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Vaccines, Volume 12, Issue 5 (May 2024) – 116 articles

Cover Story (view full-size image): This study demonstrates that chronic opioid intake upregulates a distinct profile of plasma TNF superfamily (SF) molecules that are associated with immune cell interactions between Dendritic cells and T and B cells, which are important for antibody responses. In a study of people with HIV (PWH), those with associated opioid use disorder (OUD) exhibited higher post-flu vaccine antibody responses than PWH without OUD. The plasma profile in PWH+OUD was dominant in co-stimulatory TNF SF molecules, including 4-1BB, OX-40, CD40, CD30, and 4-1BBL and positively correlated with Flu Ab titers. In PWH without OUD, Ig SF molecules, including PDL-2, CTLA-4, and Perforin were dominant, with PDL-2 showing a negative correlation with Flu Ab titers. The role of opioid receptors and SF signaling pathways may reveal novel therapeutic strategies for immune-deficient states. View this paper
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28 pages, 6678 KiB  
Article
Healthcare Providers’ and Pregnant People’s Preferences for a Preventive to Protect Infants from Serious Illness Due to Respiratory Syncytial Virus
by Kathleen M. Beusterien, Amy W. Law, Martine C. Maculaitis, Oliver Will, Lewis Kopenhafer, Patrick Olsen, Brett Hauber, Jeffrey T. Vietri, Joseph C. Cappelleri, Joshua R. Coulter and Kimberly M. Shea
Vaccines 2024, 12(5), 560; https://doi.org/10.3390/vaccines12050560 - 20 May 2024
Viewed by 573
Abstract
We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were [...] Read more.
We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were recruited via convenience sample from a general research panel to complete a cross-sectional, web-based survey, including a discrete choice experiment (DCE) wherein respondents chose between hypothetical RSV preventive profiles varying on five attributes (effectiveness, preventive type [maternal vaccine vs. mAb], injection recipient/timing, type of medical visit required to receive the injection, and duration of protection during RSV season) and a no-preventive option. A best–worst scaling (BWS) exercise was included to explore the impact of additional attributes on preventive preferences. Data were collected between October and November 2022. Attribute-level preference weights and relative importance (RI) were estimated. Overall, 992 pregnant people and 310 HCPs participated. A preventive (vs. none) was chosen 89.2% (pregnant people) and 96.0% (HCPs) of the time (DCE). Effectiveness was most important to preventive choice for pregnant people (RI = 48.0%) and HCPs (RI = 41.7%); all else equal, pregnant people (RI = 5.5%) and HCPs (RI = 7.2%) preferred the maternal vaccine over mAbs, although preventive type had limited influence on choice. Longer protection, protection starting at birth or the beginning of RSV season, and use for both pre-term and full-term babies were ranked highest in importance (BWS). Pregnant people and HCPs strongly preferred a preventive to protect infants against RSV (vs. none), underscoring the need to incorporate RSV preventives into routine care. Full article
(This article belongs to the Special Issue Public Psychobehavioral Responses towards Vaccination)
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25 pages, 6146 KiB  
Article
The Biodistribution of the Spike Protein after Ad26.COV2.S Vaccination Is Unlikely to Play a Role in Vaccine-Induced Immune Thrombotic Thrombocytopenia
by Sonia Marquez-Martinez, Selina Khan, Joan van der Lubbe, Laura Solforosi, Lea M. M. Costes, Ying Choi, Satish Boedhoe, Mieke Verslegers, Marjolein van Heerden, Wendy Roosen, Sandra De Jonghe, Hendy Kristyanto, Veronica Rezelj, Jenny Hendriks, Jan Serroyen, Jeroen Tolboom, Frank Wegmann and Roland C. Zahn
Vaccines 2024, 12(5), 559; https://doi.org/10.3390/vaccines12050559 - 20 May 2024
Viewed by 757
Abstract
Ad26.COV2.S vaccination can lead to vaccine-induced immune thrombotic thrombocytopenia (VITT), a rare but severe adverse effect, characterized by thrombocytopenia and thrombosis. The mechanism of VITT induction is unclear and likely multifactorial, potentially including the activation of platelets and endothelial cells mediated by the [...] Read more.
Ad26.COV2.S vaccination can lead to vaccine-induced immune thrombotic thrombocytopenia (VITT), a rare but severe adverse effect, characterized by thrombocytopenia and thrombosis. The mechanism of VITT induction is unclear and likely multifactorial, potentially including the activation of platelets and endothelial cells mediated by the vaccine-encoded spike protein (S protein). Here, we investigated the biodistribution of the S protein after Ad26.COV2.S dosing in three animal models and in human serum samples. The S protein was transiently present in draining lymph nodes of rabbits after Ad26.COV2.S dosing. The S protein was detected in the serum in all species from 1 day to 21 days after vaccination with Ad26.COV2.S, but it was not detected in platelets, the endothelium lining the blood vessels, or other organs. The S protein S1 and S2 subunits were detected at different ratios and magnitudes after Ad26.COV2.S or COVID-19 mRNA vaccine immunization. However, the S1/S2 ratio did not depend on the Ad26 platform, but on mutation of the furin cleavage site, suggesting that the S1/S2 ratio is not VITT related. Overall, our data suggest that the S-protein biodistribution and kinetics after Ad26.COV2.S dosing are likely not main contributors to the development of VITT, but other S-protein-specific parameters require further investigation. Full article
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14 pages, 2177 KiB  
Article
Accuracy of Anti-SARS-CoV-2 Antibody in Comparison with Surrogate Viral Neutralization Test in Persons Living with HIV, Systemic Lupus Erythematosus, and Chronic Kidney Disease
by Marita Restie Tiara, Chrisan Bimo Prayuda, Tara Titian Maulidya, Hofiya Djauhari, Dadang Suhendar, Rudi Wisaksana, Laniyati Hamijoyo, Rudi Supriyadi, Agnes Rengga Indrati and Bachti Alisjahbana
Vaccines 2024, 12(5), 558; https://doi.org/10.3390/vaccines12050558 - 20 May 2024
Viewed by 507
Abstract
The presence of the anti-SARS-CoV-2-RBD antibody (anti-RBD) prevents severe COVID-19. We aimed to determine the accuracy of a point-of-care anti-RBD testing implemented in persons living with HIV (PLWH), systemic lupus erythematosus (SLE), and chronic kidney disease (CKD). We enrolled 182 non-comorbid subjects and [...] Read more.
The presence of the anti-SARS-CoV-2-RBD antibody (anti-RBD) prevents severe COVID-19. We aimed to determine the accuracy of a point-of-care anti-RBD testing implemented in persons living with HIV (PLWH), systemic lupus erythematosus (SLE), and chronic kidney disease (CKD). We enrolled 182 non-comorbid subjects and 335 comorbid subjects (PLWH, SLE, CKD) to test the anti-RBD assay compared to the surrogate viral neutralization test (sVNT) as the reference test. We performed linear correlation analysis between anti-RBD and sVNT, along with an ROC analysis to ascertain the anti-RBD cutoff at 30%, 60%, and 90% inhibition of sVNT, to calculate accuracy. The correlations between anti-RBD and sVNT among all groups were excellent, with R = 0.7903, R = 0.7843, and R = 0.8153 among the non-comorbid, SLE, and CKD groups, respectively, and with significantly higher correlation among the PLWH group (R = 0.8877; p-value = 0.0072) compared to the non-comorbid group. The accuracy of the anti-RBD test among the PLWH and CKD groups was similar to that among the non-comorbid group but showed lower sensitivity in the SLE group (p = 0.000014). The specificity of the test remained high in all groups. In conclusion, the anti-RBD test had excellent correlation with the sVNT. The persistently high specificity in all groups suggests that this test can be reliably utilized to detect the presence of low neutralization capacity, prompting additional vaccination. Full article
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36 pages, 1278 KiB  
Review
Developing Next-Generation Live Attenuated Vaccines for Porcine Epidemic Diarrhea Using Reverse Genetic Techniques
by Ruisong Yu, Shijuan Dong, Bingqing Chen, Fusheng Si and Chunhua Li
Vaccines 2024, 12(5), 557; https://doi.org/10.3390/vaccines12050557 - 19 May 2024
Viewed by 636
Abstract
Porcine epidemic diarrhea virus (PEDV) is the etiology of porcine epidemic diarrhea (PED), a highly contagious digestive disease in pigs and especially in neonatal piglets, in which a mortality rate of up to 100% will be induced. Immunizing pregnant sows remains the most [...] Read more.
Porcine epidemic diarrhea virus (PEDV) is the etiology of porcine epidemic diarrhea (PED), a highly contagious digestive disease in pigs and especially in neonatal piglets, in which a mortality rate of up to 100% will be induced. Immunizing pregnant sows remains the most promising and effective strategy for protecting their neonatal offspring from PEDV. Although half a century has passed since its first report in Europe and several prophylactic vaccines (inactivated or live attenuated) have been developed, PED still poses a significant economic concern to the swine industry worldwide. Hence, there is an urgent need for novel vaccines in clinical practice, especially live attenuated vaccines (LAVs) that can induce a strong protective lactogenic immune response in pregnant sows. Reverse genetic techniques provide a robust tool for virological research from the function of viral proteins to the generation of rationally designed vaccines. In this review, after systematically summarizing the research progress on virulence-related viral proteins, we reviewed reverse genetics techniques for PEDV and their application in the development of PED LAVs. Then, we probed into the potential methods for generating safe, effective, and genetically stable PED LAV candidates, aiming to provide new ideas for the rational design of PED LAVs. Full article
(This article belongs to the Special Issue Porcine Virus and Vaccines)
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8 pages, 2151 KiB  
Brief Report
Analysis of Acute Phase Response Using Acute Phase Proteins Following Simultaneous Vaccination of Lumpy Skin Disease and Foot-and-Mouth Disease
by Jiyeon Kim, Danil Kim, Hyoeun Noh, Leegon Hong, Eunwoo Chun, Eunkyung Kim, Younghye Ro and Woojae Choi
Vaccines 2024, 12(5), 556; https://doi.org/10.3390/vaccines12050556 - 19 May 2024
Viewed by 533
Abstract
Since 2011, South Korea has implemented biannual vaccinations against foot-and-mouth disease (FMD) and recently, lumpy skin disease (LSD), to mitigate the spread of transboundary animal diseases. However, due to past adverse reactions, potentially linked to acute phase responses from FMD vaccinations, there is [...] Read more.
Since 2011, South Korea has implemented biannual vaccinations against foot-and-mouth disease (FMD) and recently, lumpy skin disease (LSD), to mitigate the spread of transboundary animal diseases. However, due to past adverse reactions, potentially linked to acute phase responses from FMD vaccinations, there is hesitancy among Korean livestock farmers regarding new strategies for simultaneous vaccinations against both FMD and LSD. This study was conducted to assess possible adverse reactions to the LSD vaccination by analyzing acute phase proteins (APPs) in three groups: cows vaccinated against FMD (G1-FMDV), LSD (G2-LSDV), and both (G3-FMDV/LSDV). In G1-FMDV, APP levels peaked on day 3 post-vaccination (p < 0.001) and returned to baseline. In G2-LSDV, APP levels increased gradually, peaking on day 10 post-vaccination. In G3-FMDV/LSDV, APP levels peaked on day 3 post-vaccination and remained high until day 10 (p < 0.001). These results indicate that LSD vaccines trigger a later immune response compared to FMD vaccines, possibly due to different adjuvants. Therefore, a longer follow-up period for monitoring adverse reactions to LSD vaccinations may be required to understand and mitigate potential risks. Full article
(This article belongs to the Special Issue Vaccines and Animal Health)
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10 pages, 940 KiB  
Opinion
Importance of Examining Incidentality in Vaccine Safety Assessment
by Yasusi Suzumura
Vaccines 2024, 12(5), 555; https://doi.org/10.3390/vaccines12050555 - 18 May 2024
Viewed by 437
Abstract
The author believes that the principles of statistical methods for vaccine safety can be divided into three categories: comparison of adverse event incidence rates between vaccinated and unvaccinated groups, analysis of incidentality in the vaccinated group, and a combination of both. The first [...] Read more.
The author believes that the principles of statistical methods for vaccine safety can be divided into three categories: comparison of adverse event incidence rates between vaccinated and unvaccinated groups, analysis of incidentality in the vaccinated group, and a combination of both. The first category includes the cohort study; the second, the self-controlled risk interval design (SCRI); and the third, the self-controlled case series method. A single p-value alone should not determine a scientific conclusion, and analysis should be performed using multiple statistical methods with different principles. The author believes that using both the cohort study and the SCRI for analysis is the best method to assess vaccine safety. When the cohort study may not detect a significant difference owing to a low incidence rate of an adverse event in the vaccinated group or a high one in the unvaccinated group, the SCRI may detect it. Because vaccines must have a higher level of safety than the pharmaceuticals used for treatment, vaccine safety is advisable to be assessed using methods that can detect a significant difference even for any value of the incidence rate of an adverse event. The author believes that the analyses of COVID-19 vaccine safety have areas for improvement because the proportion of papers that used the cohort study and the SCRI was negligible. Full article
(This article belongs to the Section Vaccine Efficacy and Safety)
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24 pages, 1262 KiB  
Review
SARS-CoV-2 Neutralization Assays Used in Clinical Trials: A Narrative Review
by Yeqing Sun, Weijin Huang, Hongyu Xiang and Jianhui Nie
Vaccines 2024, 12(5), 554; https://doi.org/10.3390/vaccines12050554 - 18 May 2024
Viewed by 605
Abstract
Since the emergence of COVID-19, extensive research efforts have been undertaken to accelerate the development of multiple types of vaccines to combat the pandemic. These include inactivated, recombinant subunit, viral vector, and nucleic acid vaccines. In the development of these diverse vaccines, appropriate [...] Read more.
Since the emergence of COVID-19, extensive research efforts have been undertaken to accelerate the development of multiple types of vaccines to combat the pandemic. These include inactivated, recombinant subunit, viral vector, and nucleic acid vaccines. In the development of these diverse vaccines, appropriate methods to assess vaccine immunogenicity are essential in both preclinical and clinical studies. Among the biomarkers used in vaccine evaluation, the neutralizing antibody level serves as a pivotal indicator for assessing vaccine efficacy. Neutralizing antibody detection methods can mainly be classified into three types: the conventional virus neutralization test, pseudovirus neutralization test, and surrogate virus neutralization test. Importantly, standardization of these assays is critical for their application to yield results that are comparable across different laboratories. The development and use of international or regional standards would facilitate assay standardization and facilitate comparisons of the immune responses induced by different vaccines. In this comprehensive review, we discuss the principles, advantages, limitations, and application of different SARS-CoV-2 neutralization assays in vaccine clinical trials. This will provide guidance for the development and evaluation of COVID-19 vaccines. Full article
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17 pages, 4370 KiB  
Article
A Low Number of Baselines γδ T Cells Increases the Risk of SARS-CoV-2 Post-Vaccination Infection
by Juan Carlos Andreu-Ballester, Lorena Galindo-Regal, Carmen Cuéllar, Francisca López-Chuliá, Carlos García-Ballesteros, Leonor Fernández-Murga, Antonio Llombart-Cussac and María Victoria Domínguez-Márquez
Vaccines 2024, 12(5), 553; https://doi.org/10.3390/vaccines12050553 - 18 May 2024
Viewed by 506
Abstract
Background: The COVID-19 pandemic is the biggest global health problem in the last hundred years. The efficacy of the vaccine to protect against severe disease is estimated to be 70–95% according to the studies carried out, although there are aspects of the immune [...] Read more.
Background: The COVID-19 pandemic is the biggest global health problem in the last hundred years. The efficacy of the vaccine to protect against severe disease is estimated to be 70–95% according to the studies carried out, although there are aspects of the immune response to the vaccine that remain unclear. Methods: Humoral and cellular immunity after the administration of three doses of the Pfizer–BioNTech and Oxford AstraZeneca vaccines against SARS-CoV-2 over one year and the appearance of post-vaccination COVID-19 were studied. SARS-CoV-2 IgG and IgA antibodies, αβ and γδ T-cell subsets, and their differentiation stages and apoptosis were analyzed. Results: Anti-SARS-CoV-2 IgG and IgA antibodies showed a progressive increase throughout the duration of the study. This increase was the greatest after the third dose. The highest levels were observed in subjects who had anti-SARS-CoV-2 antibodies prior to vaccination. There was an increase in CD4+ αβ, CD8+ γδ and TEM CD8+ γδ T cells, and a decrease in apoptosis in CD4+ CD8+ and CD56+ αβ and γδ T cells. Post-vaccination SARS-CoV-2 infection was greater than 60%. The symptoms of COVID-19 were very mild and were related to a γδ T cell deficit, specifically CD8+ TEMRA and CD56+ γδ TEM, as well as lower pre-vaccine apoptosis levels. Conclusions: The results unveil the important role of γδ T cells in SARS-CoV-2-vaccine-mediated protection from the disease. Full article
(This article belongs to the Special Issue Immune Responses to Viruses)
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15 pages, 1632 KiB  
Article
Confronting Inequalities and Bridging the Divide: A Retrospective Study Assessment of Country-Level COVID-19 Vaccine Equality with a Cox Regression Model
by Lan Cheng, W. K. Chan, Lijie Zhu, Melody H. Chao and Yang Wang
Vaccines 2024, 12(5), 552; https://doi.org/10.3390/vaccines12050552 - 18 May 2024
Viewed by 524
Abstract
COVID-19 vaccination is vital in reducing illness, hospitalization, and mortality in the face of this global pandemic. However, COVID-19 vaccination rates worldwide remain below WHO public health targets, and persistent structural inequities reduce vaccine uptake likelihood among populations of low socioeconomic status. We [...] Read more.
COVID-19 vaccination is vital in reducing illness, hospitalization, and mortality in the face of this global pandemic. However, COVID-19 vaccination rates worldwide remain below WHO public health targets, and persistent structural inequities reduce vaccine uptake likelihood among populations of low socioeconomic status. We conducted a cross-sectional study based on publicly available data from the Our World in Data project. We included all 124 countries with available open epidemic data and a population of more than 5 million. We used a Cox Regression Model, with population, population density, median age, human development index, GDP per capita, gender inequality index, healthcare access and quality index, hospital beds per thousand people, completion rate of primary education, infection cases of COVID-19 by the end of 2022, and death rate due to COVID-19 by the end of 2022 as predictors for model hazard rates of completion of 50% population vaccination. According to our study, countries with higher populations, higher population density, higher human development index, lower gender inequality index, and lower hospital beds per 1000 people had a higher hazard rate, which means they were more likely to achieve 50% population vaccination faster. By utilizing the time to achieve vaccination rate goals as our primary endpoint, we evaluated inequity from a dual perspective, considering both the differences in vaccination rates and the duration required to attain them. Consequently, this study employed survival analysis approaches to gain a comprehensive understanding of vaccine drivers and population-level trends nationally and inform all communities from a statistical perspective to prepare for health emergencies. Development-level standing modified the effects of equal access to COVID-19 vaccination on cumulative cases and mortality, for which countries of low or medium human development tended to fare worse in outcomes than high human development countries. As COVID-19 vaccination efforts evolve, healthcare professionals, scholars, and policymakers need to identify the structural impediments to equitable vaccination awareness, access, and uptake so that future vaccination campaigns are not impeded by these barriers to immunization. Recognizing the complex nature of this significant barrier, it is evident that no single statistical analysis method can comprehensively address all intricacies. Full article
(This article belongs to the Special Issue Vaccination and Global Health)
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11 pages, 810 KiB  
Article
Vaccine Acceptance in Patients with Inflammatory Bowel Disease: Lessons Learned from the COVID-19 Pandemic
by Giada Mastrangeli, Filippo Vernia, Stefano Necozione, Mario Muselli, Sara Frassino, Nicola Cesaro, Giovanni Latella and Leila Fabiani
Vaccines 2024, 12(5), 551; https://doi.org/10.3390/vaccines12050551 - 18 May 2024
Viewed by 473
Abstract
Background: Immunomodulating therapies, which are commonly used in patients with Crohn’s disease (CD) and ulcerative colitis (UC), have been linked to an increased risk of contracting opportunistic infectious diseases, the majority of which are preventable through vaccination. Nonetheless, vaccination rates in these patients [...] Read more.
Background: Immunomodulating therapies, which are commonly used in patients with Crohn’s disease (CD) and ulcerative colitis (UC), have been linked to an increased risk of contracting opportunistic infectious diseases, the majority of which are preventable through vaccination. Nonetheless, vaccination rates in these patients are suboptimal, and frequently lower than in the general population. The COVID-19 immunization schedule provided a new scenario for investigating vaccine acceptance in patients with inflammatory bowel disease (IBD), with uncertainty and concerns emerging and the number of subjects receiving the third and fourth doses of the vaccine gradually decreasing. This study investigated IBD patients’ attitudes towards previous COVID-19 vaccine programs and identified the factors that influence their adherence. It considered demographic and disease-related factors as well as the role of gastroenterologists and primary care physicians (PCPs). Methods: Data were collected through a self-completed questionnaire administered to all adult IBD patients (age > 18) who visited the Gastroenterology, Hepatology, and Nutrition division at the University of L’Aquila (Italy) for a regular follow-up between November 2021 and December 2022. Non-IBD gastroenterological outpatients who visited during the same period were included as a control group. Results: A total of 178 patients were included in the analysis. The IBD group consisted of 77 patients, 48.1% with CD and 51.9% with UC; the mean age was 49.5 years and 51.9% were female. Overall, 94.8% of IBD patients had undergone at least one vaccine dose and 79.2% had received two doses, versus 8% of the control group (p < 0.0001). A total of 84.4% of IBD patients reported their propensity towards COVID-19 vaccination, with an average agreement score significantly higher than the controls (p = 0.0044). The trust of IBD patients in the effectiveness of the COVID-19 vaccine (p < 0.0001) and its role in hastening pandemic resolution (p < 0.0001) is strongly related to motivation and propensity. Concerns about the safety of the COVID-19 vaccine in IBD (p = 0.0202) and fear of vaccine-induced flare-ups (p = 0.0192) were reported as the main barriers. No correlation was found between COVID-19 vaccine propensity and clinical features like the type of IBD, years of disease, activity, and ongoing treatment. Regarding the recommendations received from physicians to get vaccinated against COVID-19, IBD patients relied heavily on their gastroenterologists for advice, while the control group relied mainly on their PCPs. Conclusions: The overall positive attitude towards vaccinations reported in our study was better than that observed for other vaccines. The relationship of trust with the gastroenterologist should be used to boost vaccination against other preventable diseases in IBD patients. Our findings add information on the factors influencing vaccine propensity, which can be used to improve current vaccination strategies. Full article
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22 pages, 2127 KiB  
Article
Design of a New Vaccine Prototype against Porcine Circovirus Type 2 (PCV2), M. hyopneumoniae and M. hyorhinis Based on Multiple Antigens Microencapsulation with Sulfated Chitosan
by Darwuin Arrieta-Mendoza, Bruno Garces, Alejandro A. Hidalgo, Victor Neira, Galia Ramirez, Andrónico Neira-Carrillo and Sergio A. Bucarey
Vaccines 2024, 12(5), 550; https://doi.org/10.3390/vaccines12050550 - 17 May 2024
Viewed by 542
Abstract
This work evaluated in vivo an experimental-multivalent-vaccine (EMV) based on three Porcine Respiratory Complex (PRC)-associated antigens: Porcine Circovirus Type 2 (PCV2), M. hyopneumoniae (Mhyop) and M. hyorhinis (Mhyor), microencapsulated with sulfated chitosan (M- ChS + PRC-antigens), postulating chitosan sulphate (ChS) as a mimetic [...] Read more.
This work evaluated in vivo an experimental-multivalent-vaccine (EMV) based on three Porcine Respiratory Complex (PRC)-associated antigens: Porcine Circovirus Type 2 (PCV2), M. hyopneumoniae (Mhyop) and M. hyorhinis (Mhyor), microencapsulated with sulfated chitosan (M- ChS + PRC-antigens), postulating chitosan sulphate (ChS) as a mimetic of the heparan sulfate receptor used by these pathogens for cell invasion. The EMV was evaluated physicochemically by SEM (Scanning-Electron-Microscopy), EDS (Energy-Dispersive-Spectroscopy), Pdi (Polydispersity-Index) and zeta potential. Twenty weaned pigs, distributed in four groups, were evaluated for 12 weeks. The groups 1 through 4 were as follows: 1-EMV intramuscular-route (IM), 2-EMV oral-nasal-route (O/N), 3-Placebo O/N (M-ChS without antigens), 4-Commercial-vaccine PCV2-Mhyop. qPCR was used to evaluate viral/bacterial load from serum, nasal and bronchial swab and from inguinal lymphoid samples. Specific humoral immunity was evaluated by ELISA. M-ChS + PRC-antigens measured between 1.3–10 μm and presented low Pdi and negative zeta potential, probably due to S (4.26%). Importantly, the 1-EMV protected 90% of challenged animals against PCV2 and Mhyop and 100% against Mhyor. A significant increase in antibody was observed for Mhyor (1-EMV and 2-EMV) and Mhyop (2-EMV), compared with 4-Commercial-vaccine. No difference in antibody levels between 1-EMV and 4-Commercial-vaccine for PCV2-Mhyop was observed. Conclusion: The results demonstrated the effectiveness of the first EMV with M-ChS + PRC-antigens in pigs, which were challenged with Mhyor, PCV2 and Mhyop, evidencing high protection for Mhyor, which has no commercial vaccine available. Full article
(This article belongs to the Topic Advances in Vaccines and Antimicrobial Therapy)
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11 pages, 879 KiB  
Article
Safety and Efficacy of Nirsevimab in a Universal Prevention Program of Respiratory Syncytial Virus Bronchiolitis in Newborns and Infants in the First Year of Life in the Valle d’Aosta Region, Italy, in the 2023–2024 Epidemic Season
by Alessandra Consolati, Mariapaola Farinelli, Paolo Serravalle, Christine Rollandin, Laura Apprato, Susanna Esposito and Salvatore Bongiorno
Vaccines 2024, 12(5), 549; https://doi.org/10.3390/vaccines12050549 - 17 May 2024
Viewed by 1104
Abstract
Respiratory syncytial virus (RSV) bronchiolitis remains a significant global health burden, particularly in newborns and infants during their first year of life. The quest for an effective preventive strategy against RSV has long been sought, and recent developments have shown promise in the [...] Read more.
Respiratory syncytial virus (RSV) bronchiolitis remains a significant global health burden, particularly in newborns and infants during their first year of life. The quest for an effective preventive strategy against RSV has long been sought, and recent developments have shown promise in the form of nirsevimab, a monoclonal antibody specifically designed for RSV prophylaxis. Valle d’Aosta was the first Italian region to propose universal prophylaxis with nirsevimab for newborns and infants in their first epidemic season as early as 2023–2024. This study describes the effectiveness and safety of the universal prevention program of RSV bronchiolitis using the monoclonal antibody nirsevimab in children resident in Valle d’Aosta born during the 2023–2024 epidemic season. There were 556 neonates born from 1 May 2023 to 15 February 2024. The risk of hospitalization for RSV bronchiolitis in 2023–2024 was 3.2%, compared to 7% in the 2022–2023 epidemic season (p < 0.001). After the start of the prophylaxis campaign with nirsevimab, the risk of hospitalization was 8.3% in the sample of infants who did not adhere to the prophylaxis, while no child in the sample of those treated (p < 0.001) was hospitalized for bronchiolitis. Few mild transient side effects were reported. This study shows the efficacy and safety of universal prophylaxis with nirsevimab in neonates, making Valle d’Aosta the first Italian region to offer universal prophylaxis to newborns without risk factors for RSV complications. Future research could further explore its long-term impact and cost-effectiveness. Full article
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18 pages, 1672 KiB  
Systematic Review
Genital Warts in Women Vaccinated against HPV in Childhood: A Systematic Review
by Renata Malheiro, César Magalhães, Cláudia Camila Dias, Acácio Gonçalves Rodrigues and Carmen Lisboa
Vaccines 2024, 12(5), 548; https://doi.org/10.3390/vaccines12050548 - 17 May 2024
Viewed by 579
Abstract
Human papillomavirus (HPV) is the most prevalent sexually transmitted infection among young women. Notably, more than ten years after the introduction of HPV vaccination programs in Europe, it is essential to review the real-world evidence of the incidence of anogenital warts (GWs) among [...] Read more.
Human papillomavirus (HPV) is the most prevalent sexually transmitted infection among young women. Notably, more than ten years after the introduction of HPV vaccination programs in Europe, it is essential to review the real-world evidence of the incidence of anogenital warts (GWs) among women vaccinated during childhood. In this systematic review, three databases were searched for studies published between January 2008 and September 2023. Nine cohort studies were included. A total of 890,320 HPV-vaccinated women and 1,922,033 unvaccinated women were evaluated. All the studies but one investigated the 4vHPV vaccine. The incidence rate of GWs in vaccinated women ranged from 0.0 to 1650 per 100,000 person-years. The highest incidence rates were found in women vaccinated with one dose at the age of 17–19 years old and in fully vaccinated women only after 19 years of age. Similar incidence values were reported among unvaccinated women. The incidence of GWs was lower when the age at first dose was 9–11 years old. This systematic review reveals that the incidence of GWs among HPV-vaccinated women is related to the age of vaccination and the number of vaccine doses received. In the post-vaccination era, epidemiological surveillance of the incidence of GWs and their genotypes is crucial. Full article
(This article belongs to the Section Human Papillomavirus Vaccines)
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11 pages, 706 KiB  
Article
Safety and Efficacy of VIT against Wasp Venom in Ultra-Rush Protocols in Patients Older Than 60 Years
by Andrzej Bożek, Janne Winterstein, Robert Pawłowicz, Ian Poians, Dominika Sadowska, Martyna Miodonska and Marita Nittner-Marszalska
Vaccines 2024, 12(5), 547; https://doi.org/10.3390/vaccines12050547 - 16 May 2024
Viewed by 377
Abstract
Background: Allergen immunotherapy remains a widely recognized and widely used method for the treatment of selected allergic diseases. Currently, according to the European Academy Of Allergy and Clinical Immunology (EAACI) guidelines, venom immunotherapy (VIT) may be considered for patients over 60. Nevertheless, no [...] Read more.
Background: Allergen immunotherapy remains a widely recognized and widely used method for the treatment of selected allergic diseases. Currently, according to the European Academy Of Allergy and Clinical Immunology (EAACI) guidelines, venom immunotherapy (VIT) may be considered for patients over 60. Nevertheless, no separate studies have confirmed the efficacy and safety of this therapy. This study aimed to evaluate the short-term effectiveness of VIT against wasp allergens in an ultra-rush protocol for older patients compared to young patients. Methods: Among the 113 patients included in this study, 51 were older than 60 years (Group A), and 62 formed the control “young group” (age range: 18–35 years). All patients were desensitized to wasp venom using the ultra-rush protocol according to Muller and aqueous solutions of vaccines containing wasp venom. A basophil activation test (Basotest, Orpegen Pharma, Germany) and intracutaneous tests with dilutions of wasp allergen and specific IgE to extract wasp venom were performed at the start and after six months of VIT. The safety of VIT was assessed on the basis of the international Mueller scale. Results: One hundred and eleven patients with confirmed wasp allergies completed six months of VIT: 51 participants over 60 years of age (Group A) and 60 young people (Group B). No systemic adverse reactions were observed during the VIT induction phase. However, large local reactions were noted in 17% of older patients and 20% of young patients at a similar level (p > 0.05). During maintenance VIT, two mild grade I systemic reactions were confirmed in young patients. These symptoms resolved spontaneously. There were no such reactions in older patients. The effectiveness of VIT was tested using BAT. There was a statistically significant reduction in CD63 reactivity in 86% of patients in Group A, and a comparable and substantial decrease in 84% of young patients in Group B. According to the BAT test, the mean reductions in the area under the curve (AUC) after six months of VIT were significant (p < 0.05) and comparable between Groups A and B: −6.52 vs. 7.21. Conclusions: VIT against wasp venom is safe and effective in short-term observation, and is comparable to that used for young patients. Full article
(This article belongs to the Special Issue Immunosenescence and Vaccine Immune Responses)
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19 pages, 1140 KiB  
Article
A Self-Assembling Pfs230D1-Ferritin Nanoparticle Vaccine Has Potent and Durable Malaria Transmission-Reducing Activity
by Nichole D. Salinas, Rui Ma, Holly McAleese, Tarik Ouahes, Carole A. Long, Kazutoyo Miura, Lynn E. Lambert and Niraj H. Tolia
Vaccines 2024, 12(5), 546; https://doi.org/10.3390/vaccines12050546 - 16 May 2024
Viewed by 612
Abstract
Malaria is caused by eukaryotic protozoan parasites of the genus Plasmodium. There are 249 million new cases and 608,000 deaths annually, and new interventions are desperately needed. Malaria vaccines can be divided into three categories: liver stage, blood stage, or transmission-blocking vaccines. [...] Read more.
Malaria is caused by eukaryotic protozoan parasites of the genus Plasmodium. There are 249 million new cases and 608,000 deaths annually, and new interventions are desperately needed. Malaria vaccines can be divided into three categories: liver stage, blood stage, or transmission-blocking vaccines. Transmission-blocking vaccines prevent the transmission of disease by the mosquito vector from one human to another. Pfs230 is one of the leading transmission-blocking vaccine antigens for malaria. Here, we describe the development of a 24-copy self-assembling nanoparticle vaccine comprising domain 1 of Pfs230 genetically fused to H. pylori ferritin. The single-component Pfs230D1-ferritin construct forms a stable and homogenous 24-copy nanoparticle with good production yields. The nanoparticle is highly immunogenic, as two low-dose vaccinations of New Zealand White rabbits elicited a potent and durable antibody response with high transmission-reducing activity when formulated in two distinct adjuvants suitable for translation to human use. This single-component 24-copy Pfs230D1-ferritin nanoparticle vaccine has the potential to improve production pipelines and the cost of manufacturing a potent and durable transmission-blocking vaccine for malaria control. Full article
(This article belongs to the Special Issue Vaccines against Arthropods and Arthropod-Borne Pathogens)
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15 pages, 2366 KiB  
Article
Investigating the Spatial Accessibility and Coverage of the Pediatric COVID-19 Vaccine: An Ecologic Study of Regional Health Data
by Amin Bemanian and Jonathan F. Mosser
Vaccines 2024, 12(5), 545; https://doi.org/10.3390/vaccines12050545 - 15 May 2024
Viewed by 421
Abstract
The COVID-19 pandemic presented the unique challenge of having to deliver novel vaccines during a public health crisis. For pediatric patients, it was further complicated by the delayed timeline for authorizing the vaccine and the differences in dosing/products depending on the patient’s age. [...] Read more.
The COVID-19 pandemic presented the unique challenge of having to deliver novel vaccines during a public health crisis. For pediatric patients, it was further complicated by the delayed timeline for authorizing the vaccine and the differences in dosing/products depending on the patient’s age. This paper investigates the relationship between the spatial accessibility and uptake of the COVID-19 vaccine in King County, WA, USA. Public data for COVID-19 vaccine sites were used to calculate spatial accessibility using an enhanced two-step floating catchment area (E2SFCA) technique. Spatial regression analyses were performed to look at the relationship between spatial accessibility and ZIP-code-level vaccination rates. The relationships of these data with other socioeconomic and demographic variables were calculated as well. Higher rates of vaccine accessibility and vaccine coverage were found in adolescent (12- to 17-year-old) individuals relative to school-age (5- to 11-year-old) individuals. Vaccine accessibility was positively associated with coverage in both age groups in the univariable analysis. This relationship was affected by neighborhood educational attainment. This paper demonstrates how measures such as E2SFCA can be used to calculate the accessibility of the COVID-19 vaccine in a region and provides insight into some of the ecological factors that affect COVID-19 vaccination rates. Full article
(This article belongs to the Section COVID-19 Vaccines and Vaccination)
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13 pages, 1851 KiB  
Article
Immunogenicity and Protective Capacity of Sugar ABC Transporter Substrate-Binding Protein against Streptococcus suis Serotype 2, 7 and 9 Infection in Mice
by Zujie Yan, Ruyi Pan, Junjie Zhang, Jianhe Sun, Xiaochun Ma, Nihua Dong, Xiaohui Yao, Jianchao Wei, Ke Liu, Yafeng Qiu, Katie Sealey, Hester Nichols, Michael A. Jarvis, Mathew Upton, Xiangdong Li, Zhiyong Ma, Juxiang Liu and Beibei Li
Vaccines 2024, 12(5), 544; https://doi.org/10.3390/vaccines12050544 - 15 May 2024
Viewed by 564
Abstract
Background: Streptococcus suis (S. suis) is a Gram-positive bacterium that causes substantial disease in pigs. S. suis is also an emerging zoonoses in humans, primarily in Asia, through the consumption of undercooked pork and the handling of infected pig meat [...] Read more.
Background: Streptococcus suis (S. suis) is a Gram-positive bacterium that causes substantial disease in pigs. S. suis is also an emerging zoonoses in humans, primarily in Asia, through the consumption of undercooked pork and the handling of infected pig meat as well as carcasses. The complexity of S. suis epidemiology, characterized by the presence of multiple bacterial serotypes and strains with diverse sequence types, identifies a critical need for a universal vaccine with the ability to confer cross-protective immunity. Highly conserved immunogenic proteins are generally considered good candidate antigens for subunit universal vaccines. Methods: In this study, the cross-protection of the sugar ABC transporter substrate-binding protein (S-ABC), a surface-associated immunogenic protein of S. suis, was examined in mice for evaluation as a universal vaccine candidate. Results: S-ABC was shown to be highly conserved, with 97% amino acid sequence identity across 31 S. suis strains deposited in GenBank. Recombinantly expressed S-ABC (rS-ABC) was recognized via rabbit sera specific to S. suis serotype 2. The immunization of mice with rS-ABC induced antigen-specific antibody responses, as well as IFN-γ and IL-4, in multiple organs, including the lungs. rS-ABC immunization conferred high (87.5% and 100%) protection against challenges with S. suis serotypes 2 and 9, demonstrating high cross-protection against these serotypes. Protection, albeit lower (50%), was also observed in mice challenged with S. suis serotype 7. Conclusions: These data identify S-ABC as a promising antigenic target within a universal subunit vaccine against S. suis. Full article
(This article belongs to the Section Veterinary Vaccines)
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14 pages, 1374 KiB  
Communication
Innate and Adaptive Immune Parameters following mRNA Vaccination in Mice
by Srinivasa Reddy Bonam, Nicholas C. Hazell, Mano Joseph Mathew, Yuejin Liang, Xuxiang Zhang, Zhi Wei, Mohamad-Gabriel Alameh, Drew Weissman and Haitao Hu
Vaccines 2024, 12(5), 543; https://doi.org/10.3390/vaccines12050543 - 15 May 2024
Viewed by 795
Abstract
The COVID-19 pandemic has raised the standard regarding the current vaccine development pace, as several messenger RNA (mRNA)-lipid nanoparticle (LNP) vaccines have proved their ability to induce strong immunogenicity and protective efficacy. We developed 1-methylpseudouridine-containing mRNA-LNP vaccines, expressing either the more conserved SARS-CoV-2 [...] Read more.
The COVID-19 pandemic has raised the standard regarding the current vaccine development pace, as several messenger RNA (mRNA)-lipid nanoparticle (LNP) vaccines have proved their ability to induce strong immunogenicity and protective efficacy. We developed 1-methylpseudouridine-containing mRNA-LNP vaccines, expressing either the more conserved SARS-CoV-2 nucleoprotein (mRNA-N) or spike protein (mRNA-S), both based on the prototypic viral sequences. When combining both mRNA-S and mRNA-N together (mRNA-S+N), the vaccine showed high immunogenicity and broad protection against different SARS-CoV-2 variants, including wildtype, Delta, BA.1, BA.5, and BQ.1. To better understand the mechanisms behind this broad protection obtained by mRNA-S+N, we analyzed innate and adaptive immune parameters following vaccination in mice. Compared to either mRNA-S or mRNA-N alone, mice vaccinated with mRNA-S+N exhibited an increase in the innate immune response, as depicted by the higher cytokine (IL-6 and chemokine (MCP-1) levels. In addition, lymph node immunophenotyping showed the maturation and activation of dendritic cells and natural killer cells, respectively. To understand the adaptive immune response, RNA-Seq analyses of the lung and spleen samples of the vaccinated mice were performed in parallel and revealed a stronger immune gene-expression profile in the lung than that in the spleen. Compared to mRNA-S alone, mRNA-S+N vaccination elicited higher levels of expression for genes involved in multiple immune pathways, including T cells, cytokine signaling, antigen presentation, B cells, and innate immunity. Together, our studies provide immunological insights into the mechanisms of broad protection conferred by dual mRNA vaccination against SARS-CoV-2 variants. Full article
(This article belongs to the Special Issue Advances in the Use of Nanoparticles for Vaccine Platform Development)
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16 pages, 269 KiB  
Article
Selecting and Tailoring Implementation Strategies to Improve Human Papillomavirus Vaccine Uptake in Zambia: A Nominal Group Technique Approach
by Mwansa Ketty Lubeya, Mulindi Mwanahamuntu, Carla J. Chibwesha, Moses Mukosha and Mary Kawonga
Vaccines 2024, 12(5), 542; https://doi.org/10.3390/vaccines12050542 - 15 May 2024
Viewed by 431
Abstract
The human papillomavirus (HPV) vaccine is effective in cervical cancer prevention. However, many barriers to uptake exist and strategies to overcome them are needed. Therefore, this study aimed to select and tailor implementation strategies to barriers identified by multiple stakeholders in Zambia. The [...] Read more.
The human papillomavirus (HPV) vaccine is effective in cervical cancer prevention. However, many barriers to uptake exist and strategies to overcome them are needed. Therefore, this study aimed to select and tailor implementation strategies to barriers identified by multiple stakeholders in Zambia. The study was conducted in Lusaka district between January and February 2023. Participants were purposively sampled from three stakeholder groups namely, adolescent girls, parents, and teachers and healthcare workers. With each of the stakeholders’ groups (10–13 participants per group), we used the nominal group technique to gain consensus to tailor feasible and acceptable implementation strategies for mitigating the identified contextual barriers. The identified barriers included low levels of knowledge and awareness about the HPV vaccine, being out of school, poor community sensitisation, lack of parental consent to vaccinate daughters, and myths and misinformation about the HPV vaccine. The lack of knowledge and awareness of the HPV vaccine was a common barrier across the three groups. Tailored strategies included conducting educational meetings and consensus-building meetings, using mass media, changing service sites, re-examining implementation, and involving patients/consumers and their relatives. Our study contributes to the available evidence on the process of selecting and tailoring implementation strategies to overcome contextual barriers. Policymakers should consider these tailored strategies to mitigate barriers and improve HPV vaccine uptake. Full article
(This article belongs to the Special Issue Vaccine Strategies for HPV-Related Cancers)
12 pages, 2033 KiB  
Article
SARS-CoV-2-Specific Antibodies, B Cell and T Cell Immune Responses after ChAdOx1 nCoV-19 Vaccination in Solid Organ Transplant Recipients
by Pattaraphorn Phornkittikorn, Surasak Kantachuvesiri, Abhasnee Sobhonslidsuk, Teerapat Yingchoncharoen, Sasisopin Kiertiburanakul and Jackrapong Bruminhent
Vaccines 2024, 12(5), 541; https://doi.org/10.3390/vaccines12050541 - 15 May 2024
Viewed by 485
Abstract
Background: Immunization against SARS-CoV-2 is essential for vulnerable solid organ transplant (SOT) recipients who are at risk of infection. However, there are concerns about suboptimal immunogenicity, especially in humoral immunity (HMI), and limited exploration of cell-mediated immune (CMI) responses. The primary objective of [...] Read more.
Background: Immunization against SARS-CoV-2 is essential for vulnerable solid organ transplant (SOT) recipients who are at risk of infection. However, there are concerns about suboptimal immunogenicity, especially in humoral immunity (HMI), and limited exploration of cell-mediated immune (CMI) responses. The primary objective of this study was to assess the immunogenicity of ChAdOx1 nCoV-19 vaccination in SOT recipients. The secondary endpoint was to evaluate factors that affect immunogenicity and adverse events (AEs) following immunization in SOT recipients. Methods: All adult SOT recipients who received the two-dose ChAdOx1 nCoV-19 vaccine at a 12-week interval underwent measurements of HMI by evaluating anti-receptor-binding domain (RBD) IgG levels and CMI by investigating SARS-CoV-2-specific T cell and B cell responses before and after complete vaccination, around 2–4 weeks post-vaccination, and compared to controls. AEs were monitored in all participants. Results: The study included 63 SOT recipients: 44 kidney recipients, 16 liver recipients, and 3 heart transplant recipients, along with 11 immunocompetent controls. Among SOT recipients, 36% were female, and the median (IQR) age was 52 (42–61). The median (IQR) time since transplant was 55 (28–123) months. After the second dose, the median (IQR) anti-RBD antibody levels were significantly lower in SOT recipients compared to those in the control group (8.3 [0.4–46.0] vs. 272.2 [178.1–551.6] BAU/mL, p < 0.01). This resulted in a seroconversion rate (anti-RBD antibody > 7.1 BAU/mL) of 51% among SOT recipients and 100% among controls (p = 0.008). Receiving the vaccine beyond one year post-transplant significantly affected seroconversion (OR 9.04, 95% CI 1.04–78.56, p = 0.046), and low-dose mycophenolic acid marginally affected seroconversion (OR 2.67, 95% CI 0.89–7.96, p = 0.079). RBD-specific B cell responses were also significantly lower compared to those in the control group (0 [0–4] vs. 10 [6–22] SFUs/106 PBMCs, p = 0.001). Similarly, S1- and SNMO-specific T cell responses were significantly lower compared to those in the control group (48 [16–128] vs. 216 [132–356] SFUs/106 PBMCs, p = 0.004 and 20 [4–48] vs. 92 [72–320] SFUs/106 PBMCs, p = 0.004). AEs were generally mild and spontaneously resolved. Conclusions: SOT recipients who received the full two-dose ChAdOx1 nCoV-19 vaccine demonstrated significantly diminished HMI and CMI responses compared to immunocompetent individuals. Consideration should be given to administering additional vaccine doses or optimizing immunosuppressant regimens during vaccination (Thai Clinical Trial Registry: TCTR20210523002). Full article
(This article belongs to the Special Issue RNA-Based Vaccines Development)
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17 pages, 2345 KiB  
Article
Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults
by Kusnandi Rusmil, Eddy Fadlyana, Rodman Tarigan Girsang, Riyadi Adrizain, Andri Reza Rahmadi, Hendarsyah Suryadinata, Muhammad Gilang Dwi Putra, Frizka Primadewi Fulendry, Dinda Tiaraningrum Nashsyah, Rona Kania Utami, Behesti Zahra Mardiah, I Gusti Ayu Trisna Windiani, I Gusti Agung Ngurah Sugitha Adnyana, Ni Luh Sukma Pratiwi Murti, I Ketut Agus Somia, I Made Susila Utama, Soetjiningsih Soetjiningsih, Ulfa Luthfiani Nurkamila Mutiara and Mita Puspita
Vaccines 2024, 12(5), 540; https://doi.org/10.3390/vaccines12050540 - 14 May 2024
Viewed by 479
Abstract
According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This [...] Read more.
According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This trial was an observer-blind, randomised, prospective intervention study. This study targeted individuals who had received complete primary doses of the authorised/approved COVID-19 vaccine. The groups were divided into the primary inactivated vaccine (CoronaVac®) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac®). The groups were compared with the control and primary mRNA vaccine (BNT162b2). The participants enrolled in the study were from two primary care centres in Bandung City and three primary care centres in Denpasar City. A total of 696 participants were enrolled from 1 September to 31 October 2022. The demographic characteristics of the all-vaccine group showed a uniform distribution. The results showed that, compared with the control, the investigational product had inferior effectiveness 14 days after the booster dose was administered. However, 28 days after the booster dose, the investigational product exhibited non-inferior effectiveness compared with the primary groups that received CoronaVac® (GMR 0.76 (0.57–0.99)) and ChAdOx1 (GMR 0.72 (0.56–59.93)), but the BNT162b2 group (GMR 0.61 (0.39–0.94)) was inferior to the control. At 12 months follow-up after the booster dose, three serious adverse events (SAEs) were reported in three participants, with causality not correlated with the investigated products. Neither AEs of special interest nor severe COVID-19 cases were reported throughout the follow-up period; thus, the IndoVac® vaccine as a booster was immunogenic and safe. Until the 6-month follow-up after the booster dose, the IndoVac® vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme. Full article
(This article belongs to the Special Issue COVID-19 Vaccines and Immune Response)
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26 pages, 11864 KiB  
Article
In Silico and In Vitro Evaluation of the Molecular Mimicry of the SARS-CoV-2 Spike Protein by Common Short Constituent Sequences (cSCSs) in the Human Proteome: Toward Safer Epitope Design for Vaccine Development
by Yuya Mizuno, Wataru Nakasone, Morikazu Nakamura and Joji M. Otaki
Vaccines 2024, 12(5), 539; https://doi.org/10.3390/vaccines12050539 - 14 May 2024
Viewed by 665
Abstract
Spike protein sequences in SARS-CoV-2 have been employed for vaccine epitopes, but many short constituent sequences (SCSs) in the spike protein are present in the human proteome, suggesting that some anti-spike antibodies induced by infection or vaccination may be autoantibodies against human proteins. [...] Read more.
Spike protein sequences in SARS-CoV-2 have been employed for vaccine epitopes, but many short constituent sequences (SCSs) in the spike protein are present in the human proteome, suggesting that some anti-spike antibodies induced by infection or vaccination may be autoantibodies against human proteins. To evaluate this possibility of “molecular mimicry” in silico and in vitro, we exhaustively identified common SCSs (cSCSs) found both in spike and human proteins bioinformatically. The commonality of SCSs between the two systems seemed to be coincidental, and only some cSCSs were likely to be relevant to potential self-epitopes based on three-dimensional information. Among three antibodies raised against cSCS-containing spike peptides, only the antibody against EPLDVL showed high affinity for the spike protein and reacted with an EPLDVL-containing peptide from the human unc-80 homolog protein. Western blot analysis revealed that this antibody also reacted with several human proteins expressed mainly in the small intestine, ovary, and stomach. Taken together, these results showed that most cSCSs are likely incapable of inducing autoantibodies but that at least EPLDVL functions as a self-epitope, suggesting a serious possibility of infection-induced or vaccine-induced autoantibodies in humans. High-risk cSCSs, including EPLDVL, should be excluded from vaccine epitopes to prevent potential autoimmune disorders. Full article
(This article belongs to the Special Issue New Trends in Vaccine Characterization, Formulations, and Development)
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15 pages, 1589 KiB  
Article
DNA Vaccine Encoding a Modified Hemagglutinin Trimer of Avian Influenza A Virus H5N8 Protects Mice from Viral Challenge
by Victoria R. Litvinova, Andrey P. Rudometov, Nadezhda B. Rudometova, Denis N. Kisakov, Mariya B. Borgoyakova, Lyubov A. Kisakova, Ekaterina V. Starostina, Anastasia A. Fando, Vladimir A. Yakovlev, Elena V. Tigeeva, Ksenia I. Ivanova, Andrei S. Gudymo, Tatiana N. Ilyicheva, Vasiliy Yu. Marchenko, Artemiy A. Sergeev, Alexander A. Ilyichev and Larisa I. Karpenko
Vaccines 2024, 12(5), 538; https://doi.org/10.3390/vaccines12050538 - 14 May 2024
Viewed by 722
Abstract
The development of a safe and effective vaccine against avian influenza A virus (AIV) H5N8 is relevant due to the widespread distribution of this virus in the bird population and the existing potential risk of human infection, which can lead to significant public [...] Read more.
The development of a safe and effective vaccine against avian influenza A virus (AIV) H5N8 is relevant due to the widespread distribution of this virus in the bird population and the existing potential risk of human infection, which can lead to significant public health concerns. Here, we developed an experimental pVAX-H5 DNA vaccine encoding a modified trimer of AIV H5N8 hemagglutinin. Immunization of BALB/c mice with pVAX-H5 using jet injection elicited high titer antibody response (the average titer in ELISA was 1 × 105), and generated a high level of neutralizing antibodies against H5N8 and T-cell response, as determined by ELISpot analysis. Both liquid and lyophilized forms of pVAX-H5 DNA vaccine provided 100% protection of immunized mice against lethal challenge with influenza A virus A/turkey/Stavropol/320-01/2020 (H5N8). The results obtained indicate that pVAX-H5 has good opportunities as a vaccine candidate against the influenza A virus (H5N8). Full article
(This article belongs to the Special Issue Recent Discoveries and Developments in RNA and DNA Vaccines)
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25 pages, 1876 KiB  
Article
Very Broadly Effective Hemagglutinin-Directed Influenza Vaccines with Anti-Herpetic Activity
by David C. Bloom, Cameron Lilly, William Canty, Nuria Vilaboa and Richard Voellmy
Vaccines 2024, 12(5), 537; https://doi.org/10.3390/vaccines12050537 - 14 May 2024
Viewed by 545
Abstract
A universal vaccine that generally prevents influenza virus infection and/or illness remains elusive. We have been exploring a novel approach to vaccination involving replication-competent controlled herpesviruses (RCCVs) that can be deliberately activated to replicate efficiently but only transiently in an administration site in [...] Read more.
A universal vaccine that generally prevents influenza virus infection and/or illness remains elusive. We have been exploring a novel approach to vaccination involving replication-competent controlled herpesviruses (RCCVs) that can be deliberately activated to replicate efficiently but only transiently in an administration site in the skin of a subject. The RCCVs are derived from a virulent wild-type herpesvirus strain that has been engineered to contain a heat shock promoter-based gene switch that controls the expression of, typically, two replication-essential viral genes. Additional safety against inadvertent replication is provided by an appropriate secondary mechanism. Our first-generation RCCVs can be activated at the administration site by a mild local heat treatment in the presence of an antiprogestin. Here, we report that epidermal vaccination with such RCCVs expressing a hemagglutinin or neuraminidase of an H1N1 influenza virus strain protected mice against lethal challenges by H1N1 virus strains representing 75 years of evolution. Moreover, immunization with an RCCV expressing a subtype H1 hemagglutinin afforded full protection against a lethal challenge by an H3N2 influenza strain, and an RCCV expressing a subtype H3 hemagglutinin protected against a lethal challenge by an H1N1 strain. Vaccinated animals continued to gain weight normally after the challenge. Protective effects were even observed in a lethal influenza B virus challenge. The RCCV-based vaccines induced robust titers of in-group, cross-group and even cross-type neutralizing antibodies. Passive immunization suggested that observed vaccine effects were at least partially antibody-mediated. In summary, RCCVs expressing a hemagglutinin induce robust and very broad cross-protective immunity against influenza. Full article
(This article belongs to the Special Issue The Recent Development of Influenza Vaccine)
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9 pages, 664 KiB  
Viewpoint
Implementing Adult Hepatitis B Immunization and Screening Using Electronic Health Records: A Practical Guide
by H. Nina Kim, Kelly L. Moore, David L. Sanders, Michaela Jackson, Chari Cohen, Richard Andrews and Camilla S. Graham
Vaccines 2024, 12(5), 536; https://doi.org/10.3390/vaccines12050536 - 14 May 2024
Viewed by 1395
Abstract
Importance: Hepatitis B is a serious problem in the United States (US), with up to 2.4 million Americans living with a chronic infection. Only 26–32% of people living with hepatitis B in the US are diagnosed. Additionally, just 30% of all adults are [...] Read more.
Importance: Hepatitis B is a serious problem in the United States (US), with up to 2.4 million Americans living with a chronic infection. Only 26–32% of people living with hepatitis B in the US are diagnosed. Additionally, just 30% of all adults are vaccinated against the virus. In 2022, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) updated adult hepatitis B vaccination recommendations to include all adults aged 19–59 years and those 60 years and older with risk factors for hepatitis B. Subsequently, in 2023, the CDC recommended that all adults be screened at least one time in their lives. Observations: Electronic health record (EHR) tools (prompts, order sets, etc.) have proven to be an effective method of increasing hepatitis B screening and vaccination, but longstanding challenges and questions around hepatitis B vaccines and tests could prevent effectual EHR implementation. As the new recommendations directly impact providers who may have limited familiarity with hepatitis B, guidance on how to identify eligible patients and triggers, order sets to facilitate vaccine/test selection, and proper documentation and patient follow-up is necessary. Conclusions and Relevance: This communication offers a practical framework for health systems to build an effective EHR strategy for the updated adult hepatitis B recommendations. We also provide comprehensive responses to clinicians’ questions that are frequently asked prior to screening or vaccinating for hepatitis B. Full article
(This article belongs to the Special Issue Feature Papers of Hepatitis A, B, C and E Vaccines)
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12 pages, 1668 KiB  
Article
MV140 Mucosal Vaccine Induces Targeted Immune Response for Enhanced Clearance of Uropathogenic E. coli in Experimental Urinary Tract Infection
by Paula Saz-Leal, Marianne Morris Ligon, Carmen María Diez-Rivero, Diego García-Ayuso, Soumitra Mohanty, Marcos Viñuela, Irene Real-Arévalo, Laura Conejero, Annelie Brauner, José Luis Subiza and Indira Uppugunduri Mysorekar
Vaccines 2024, 12(5), 535; https://doi.org/10.3390/vaccines12050535 - 14 May 2024
Viewed by 724
Abstract
MV140 is an inactivated whole-cell bacterial mucosal vaccine with proven clinical efficacy against recurrent urinary tract infections (UTIs). These infections are primarily caused by uropathogenic E. coli (UPEC) strains, which are unique in their virulence factors and remarkably diverse. MV140 contains a non-UPEC [...] Read more.
MV140 is an inactivated whole-cell bacterial mucosal vaccine with proven clinical efficacy against recurrent urinary tract infections (UTIs). These infections are primarily caused by uropathogenic E. coli (UPEC) strains, which are unique in their virulence factors and remarkably diverse. MV140 contains a non-UPEC strain, suggesting that it may induce an immune response against different UPEC-induced UTIs in patients. To verify this, we experimentally evaluated the cellular and humoral responses to UTI89, a prototypical UPEC strain, in mice vaccinated with MV140, as well as the degree of protection achieved in a UPEC UTI89 model of acute cystitis. The results show that both cellular (Th1/Th17) and antibody (IgG/IgA) responses to UTI89 were induced in MV140-immunized mice. MV140 vaccination resulted in an early increased clearance of UTI89 viable bacteria in the bladder and urine following transurethral infection. This was accompanied by a highly significant increase in CD4+ T cells in the bladder and an increase in urinary neutrophils. Collectively, our results support that MV140 induces cross-reactive humoral and cellular immune responses and cross-protection against UPEC strains. Full article
(This article belongs to the Special Issue Bacterial Vaccine: Mucosal Immunity and Implications)
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15 pages, 2258 KiB  
Article
Differences in Vaccination Consultation Preferred by Primary Health Care Workers and Residents in Community Settings
by Tianshuo Zhao, Xianming Cai, Sihui Zhang, Mingting Wang, Linyi Chen, Juan Wang, Yajie Yu, Liandi Tao, Xiaoxia Xu, Jing Luo, Chao Wang, Juan Du, Yaqiong Liu, Qingbin Lu and Fuqiang Cui
Vaccines 2024, 12(5), 534; https://doi.org/10.3390/vaccines12050534 - 14 May 2024
Viewed by 509
Abstract
Objective: To evaluate the preference of primary HCWs and residents on vaccination consultation in community health services to provide evidence for vaccine hesitancy intervention strategies. Methods: A discrete choice model (DCM) was constructed to evaluate the preference difference between primary HCWs and residents [...] Read more.
Objective: To evaluate the preference of primary HCWs and residents on vaccination consultation in community health services to provide evidence for vaccine hesitancy intervention strategies. Methods: A discrete choice model (DCM) was constructed to evaluate the preference difference between primary HCWs and residents on vaccination consultation in community health services in China during May–July 2022. Results: A total of 282 residents and 204 HCWs were enrolled in this study. The residents preferred consulting with an HCW-led approach (β = 2.168), with specialized content (β = 0.954), and accompanied by telephone follow-up (β = 1.552). In contrast, the HCWs preferred face-to-face consultation (β = 0.540) with an HCW-led approach (β = 0.458) and specialized content (β = 0.409), accompanied by telephone follow-up (β = 0.831). College residents and residents with underlying self-reported disease may be near-critically inclined to choose traditional consultation (an offline, face-to-face consultation with standardized content and more prolonged duration) rather than a new-media consulting group (an online consultation with specialized content within 5 min). Urban HCWs preferred long-term consultation groups (the resident-led offline consultation with follow-up lasting more than 5 min). In contrast, rural HCWs preferred efficient consultation (the HCW-led, short-duration, standardized offline consultation mode). Conclusion: The selection preference for vaccine consultation reveals a gap between providers and demanders, with different groups exhibiting distinct preferences. Identifying these targeted gaps can help design more acceptable and efficient interventions, increasing their likelihood of success and leading to better resource allocation for policymakers to develop targeted vaccination policies. Full article
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13 pages, 1036 KiB  
Review
Current Progress in Vaccines against Merkel Cell Carcinoma: A Narrative Review and Update
by Thilo Gambichler, David Schrama, Riina Käpynen, Sera S. Weyer-Fahlbusch, Jürgen C. Becker, Laura Susok, Florian Kreppel and Nessr Abu Rached
Vaccines 2024, 12(5), 533; https://doi.org/10.3390/vaccines12050533 - 13 May 2024
Viewed by 447
Abstract
Merkel cell carcinoma is a rare, aggressive skin cancer that mainly occurs in elderly and immunocompromised patients. Due to the success of immune checkpoint inhibition in MCC, the importance of immunotherapy and vaccines in MCC has increased in recent years. In this article, [...] Read more.
Merkel cell carcinoma is a rare, aggressive skin cancer that mainly occurs in elderly and immunocompromised patients. Due to the success of immune checkpoint inhibition in MCC, the importance of immunotherapy and vaccines in MCC has increased in recent years. In this article, we aim to present the current progress and perspectives in the development of vaccines for this disease. Here, we summarize and discuss the current literature and ongoing clinical trials investigating vaccines against MCC. We identified 10 articles through a PubMed search investigating a vaccine against MCC. From the international clinical trial database Clinical.Trials.gov, we identified nine studies on vaccines for the management of MCC, of which seven are actively recruiting. Most of the identified studies investigating a vaccine against MCC are preclinical or phase 1/2 trials. The vaccine principles mainly included DNA- and (synthetic) peptide-based vaccines, but RNA-based vaccines, oncolytic viruses, and the combination of vaccines and immunotherapy are also under investigation for the treatment of MCC. Although the management of MCC is changing, when compared to times before the approval of immune checkpoint inhibitors, it will still take some time before the first MCC vaccine is ready for approval. Full article
(This article belongs to the Special Issue Vaccines and Therapeutic Approaches in Dermatological Diseases)
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21 pages, 570 KiB  
Article
The Limitations of a Hypothetical All-Variant COVID-19 Vaccine: A Simulation Study
by Robert J. Kosinski
Vaccines 2024, 12(5), 532; https://doi.org/10.3390/vaccines12050532 - 13 May 2024
Viewed by 403
Abstract
This paper simulates a hypothetical pan-coronavirus vaccine that confers immediate sterilizing immunity against all SARS-CoV-2 variants. Simulations used a SEIIS (susceptible, exposed, infective, immune, susceptible) spreadsheet model that ran two parallel subpopulations: one that accepted vaccination and another that refused it. The two [...] Read more.
This paper simulates a hypothetical pan-coronavirus vaccine that confers immediate sterilizing immunity against all SARS-CoV-2 variants. Simulations used a SEIIS (susceptible, exposed, infective, immune, susceptible) spreadsheet model that ran two parallel subpopulations: one that accepted vaccination and another that refused it. The two subpopulations could transmit infections to one another. Using data from the United States (US), the simulated vaccine was tested against limiting factors such as vaccine hesitancy, slow vaccination distribution, and the development of high-transmission variants. The vaccine was often successful at reducing cases, but high-transmission variants and discontinuation of non-pharmaceutical interventions (NPIs) such as masking greatly elevated cases. A puzzling outcome was that if NPIs were discontinued and high-transmission variants became common, the model predicted consistently higher rates of disease than are actually observed in the US in 2024. However, if cumulative exposure to virus antigens increased the duration of immunity or decreased the infectivity of the virus, the model predictions were brought back into a more realistic range. The major finding was that even when a COVID-19 vaccine always produces sterilizing immunity against every SARS-CoV-2 variant, its ability to control the epidemic can be compromised by multiple common conditions. Full article
(This article belongs to the Special Issue Immune Effectiveness of COVID-19 Vaccines)
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15 pages, 3419 KiB  
Article
Differential Regulation of DC Function, Adaptive Immunity, and MyD88 Dependence by MF59 and AS03-like Adjuvants
by Jayachandra Reddy Nakkala, Yibo Li, Labone Akter, Xinliang Kang and Xinyuan Chen
Vaccines 2024, 12(5), 531; https://doi.org/10.3390/vaccines12050531 - 13 May 2024
Viewed by 643
Abstract
MF59 and AS03 are squalene emulsion-based vaccine adjuvants with similar compositions and droplet sizes. Despite their broad use in licensed influenza vaccines, few studies compared their adjuvant effects and action mechanisms side by side. Considering the majority of adjuvants act on dendritic cells [...] Read more.
MF59 and AS03 are squalene emulsion-based vaccine adjuvants with similar compositions and droplet sizes. Despite their broad use in licensed influenza vaccines, few studies compared their adjuvant effects and action mechanisms side by side. Considering the majority of adjuvants act on dendritic cells (DCs) to achieve their adjuvant effects, this study compared MF59 and AS03-like adjuvants (AddaVax and AddaS03, respectively) to enhance antigen uptake, DC maturation, ovalbumin (OVA) and seasonal influenza vaccine-induced immune responses. Considering MF59 was reported to activate MyD88 to mediate its adjuvant effects, this study also investigated whether the above-explored adjuvant effects of AddaVax and AddaS03 depended on MyD88. We found AddaVax more potently enhanced antigen uptake at the local injection site, while AddaS03 more potently enhanced antigen uptake in the draining lymph nodes. AddaS03 but not AddaVax stimulated DC maturation. Adjuvant-enhanced antigen uptake was MyD88 independent, while AddaS03-induced DC maturation was MyD88 dependent. AddaVax and AddaS03 similarly enhanced OVA-induced IgG and subtype IgG1 antibody responses as well as influenza vaccine-induced hemagglutination inhibition antibody titers, whileAddaS03 more potently enhanced OVA-specific IgG2c antibody responses. Both adjuvants depended on MyD88 to enhance vaccine-induced antibody responses, while AddaVax depended more on MyD88 to achieve its adjuvant effects. Our study reveals similarities and differences of the two squalene emulsion-based vaccine adjuvants, contributing to our improved understanding of their action mechanisms. Full article
(This article belongs to the Special Issue Modern Adjuvants and Their Roles in Vaccine Development)
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