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Search Results (1,865)

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Keywords = vaccine effectiveness assessment

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16 pages, 1921 KiB  
Article
A Bivalent mRNA Vaccine Efficiently Prevents Gammaherpesvirus Latent Infection
by Yannan Yin, Jinkai Zang, Huichun Shi, Zhuang Wang, Linlin Kuang, Shuxia Wang, Haikun Wang, Ning Li, Xiaozhen Liang and Zhong Huang
Vaccines 2025, 13(8), 830; https://doi.org/10.3390/vaccines13080830 (registering DOI) - 4 Aug 2025
Abstract
Background: It is still challenging to develop effective vaccines against tumorigenic human gammaherpesviruses such as Epstein–Barr virus (EBV). A major obstacle is the lack of a small animal model that reproduces the natural infection course of human gammaherpesviruses to allow for proper [...] Read more.
Background: It is still challenging to develop effective vaccines against tumorigenic human gammaherpesviruses such as Epstein–Barr virus (EBV). A major obstacle is the lack of a small animal model that reproduces the natural infection course of human gammaherpesviruses to allow for proper assessment of vaccine efficacy. Murine gammaherpesvirus 68 (MHV68) is a natural pathogen of wild rodents and laboratory mice and therefore can be used as a surrogate for human gammaherpesviruses to evaluate vaccination strategies. Methods: In this study, two mRNA vaccine candidates were generated, one encoding a fusion protein of the MHV68 gH with the gL (gHgL-mRNA) and the other expressing the MHV68 gB protein (gB-mRNA). The immunogenicity and protective efficacy of the mRNA vaccine candidates were evaluated in a mouse model of MHV68 infection. Results: The gHgL-mRNA but not the gB-mRNA candidate vaccine was able to induce neutralizing antibodies in mice, whereas both vaccines could elicit antigen-specific T-cell responses. Following MHV68 intranasal inoculation, complete blocking of the establishment of viral latency was observed in some mice immunized with individual gHgL-mRNA or gB-mRNA vaccines. Notably, co-immunization with the two mRNA vaccines appeared to be more effective than individual vaccines, achieving sterile immunity in 50% of the vaccinated mice. Conclusions: This study demonstrates that immunization with mRNA platform-based subunit vaccines is indeed capable of preventing MHV68 latent infection, thus validating a safe and efficacious vaccination strategy that may be applicable to human gammaherpesviruses. Full article
(This article belongs to the Special Issue The Development of mRNA Vaccines)
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24 pages, 3039 KiB  
Article
Plasmodium falciparum Subtilisin-like Domain-Containing Protein (PfSDP), a Cross-Stage Antigen, Elicits Short-Lived Antibody Response Following Natural Infection with Plasmodium falciparum
by Jonas A. Kengne-Ouafo, Collins M. Morang’a, Nancy K. Nyakoe, Daniel Dosoo, Richmond Tackie, Joe K. Mutungi, Saikou Y. Bah, Lucas N. Amenga-Etego, Britta Urban, Gordon A. Awandare, Bismarck Dinko and Yaw Aniweh
Cells 2025, 14(15), 1184; https://doi.org/10.3390/cells14151184 - 31 Jul 2025
Viewed by 435
Abstract
With the increasing detection of artemisinin resistance to front-line antimalarials in Africa and notwithstanding the planned roll-out of RTS’S and R21 in Africa, the search for new vaccines with high efficacy remains an imperative. Towards this endeavour, we performed in silico screening to [...] Read more.
With the increasing detection of artemisinin resistance to front-line antimalarials in Africa and notwithstanding the planned roll-out of RTS’S and R21 in Africa, the search for new vaccines with high efficacy remains an imperative. Towards this endeavour, we performed in silico screening to identify Plasmodium falciparum gametocyte stage genes that could be targets of protection or diagnosis. Through the analysis we identified a gene, Pf3D7_1105800, coding for a Plasmodium falciparum subtilisin-like domain-containing protein (PfSDP) and thus dubbed the gene Pfsdp. Genetic diversity assessment revealed the Pfsdp gene to be relatively conserved across continents with signs of directional selection. Using RT qPCR and Western blots, we observed that Pfsdp is expressed in all developmental stages of the parasite both at the transcript and protein level. Immunofluorescence assays found PfSDP protein co-localizing with PfMSP-1 and partially with Pfs48/45 at the asexual and sexual stages, respectively. Further, we demonstrated that anti-PfSDP peptide-specific antibodies inhibited erythrocyte invasion by 20–60% in a dose-dependent manner, suggesting that PfSDP protein might play a role in merozoite invasion. We also discovered that PfSDP protein is immunogenic in children from different endemic areas with antibody levels increasing from acute infection to day 7 post-treatment, followed by a gradual decay. The limited effect of antibodies on erythrocyte invasion could imply that it might be more involved in other processes in the development of the parasite. Full article
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14 pages, 834 KiB  
Review
Immunization as Protection Against Long COVID in the Americas: A Scoping Review
by Gabriela Zambrano-Sánchez, Josue Rivadeneira, Carlos Manterola, Tamara Otzen and Luis Fuenmayor-González
Vaccines 2025, 13(8), 822; https://doi.org/10.3390/vaccines13080822 (registering DOI) - 31 Jul 2025
Viewed by 403
Abstract
Introduction: Long COVID syndrome is defined as persistent or new symptoms that appear after an acute SARS-CoV-2 infection and last at least three months without explanation. It is estimated that between 10% and 20% of those infected develop long COVID; however, data is [...] Read more.
Introduction: Long COVID syndrome is defined as persistent or new symptoms that appear after an acute SARS-CoV-2 infection and last at least three months without explanation. It is estimated that between 10% and 20% of those infected develop long COVID; however, data is not precise in Latin America. Although high immunization rates have reduced acute symptoms and the pandemic’s impact, there is a lack of evidence of its efficacy in preventing long COVID in the region. Methods: This scoping review followed PRISMA-ScR guidelines. Studies on vaccinated adults with long COVID from Central and South America and the Caribbean were included (Mexico was also considered). A comprehensive search across multiple databases was conducted. Data included study design, participant characteristics, vaccine type, and efficacy outcomes. Results are presented narratively and in tables. Results: Out of 3466 initial records, 8 studies met the inclusion criteria after rigorous selection processes. These studies encompassed populations from Brazil, Mexico, Latin America, and Bonaire, with 11,333 participants, 69.3% of whom were female. Vaccination, particularly with three or more doses, substantially reduces the risk and duration of long COVID. Variability was noted in the definitions and outcomes assessed across studies. Conclusions: This scoping review highlights that SARS-CoV-2 vaccination exhibits potential in reducing the burden of long COVID in the Americas. However, discrepancies in vaccine efficacy were observed depending on the study design, the population studied, and the vaccine regimen employed. Further robust, region-specific investigations are warranted to delineate the effects of vaccination on long COVID outcomes. Full article
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9 pages, 184 KiB  
Article
HPV E6/E7 mRNA Testing in the Follow-Up of HPV-Vaccinated Patients After Treatment for High-Grade Cervical Intraepithelial Neoplasia
by Adolfo Loayza, Alicia Hernandez, Ana M. Rodriguez, Belen Lopez, Cristina Gonzalez, David Hardisson, Itziar de la Pena, Maria Serrano, Rocio Arnedo and Ignacio Zapardiel
Vaccines 2025, 13(8), 823; https://doi.org/10.3390/vaccines13080823 (registering DOI) - 31 Jul 2025
Viewed by 224
Abstract
Introduction: Following up on treated high-grade cervical intraepithelial neoplasia (HSIL/CIN) lesions poses a challenge. Cervical cytology often has a high false-negative rate, while high-risk human papillomavirus (HR-HPV) DNA testing, though sensitive, lacks specificity. The detection of messenger RNA of the HR-HPV E6 and [...] Read more.
Introduction: Following up on treated high-grade cervical intraepithelial neoplasia (HSIL/CIN) lesions poses a challenge. Cervical cytology often has a high false-negative rate, while high-risk human papillomavirus (HR-HPV) DNA testing, though sensitive, lacks specificity. The detection of messenger RNA of the HR-HPV E6 and E7 oncoproteins (E6/E7 mRNA) is proposed as an indicator of viral integration, which is crucial for identifying severe lesions. Additionally, HPV vaccination could reduce recurrence rates in patients treated for high-grade cervical intraepithelial neoplasia. Objective: Our study aimed to assess the clinical utility of E6/E7 mRNA determination in the follow-up of HPV-immunized patients who were treated for HSIL/CIN. Methods: We conducted a retrospective observational study including 407 patients treated for HSIL/CIN. The recurrence rate and the validity parameters of E6/E7 mRNA testing were analyzed. Results: The recurrence rate for high-grade lesions was 1.7%. This low percentage might be related to the vaccination of patients who were not immunized before treatment. The sensitivity of the E6/E7 mRNA test was 88% at the first clinical visit, reaching 100% in the second and third reviews. Specificity was 91% at the first visit, 92% at the second, and 85% at the third. Regarding predictive values, the positive predictive value was 18% at the first visit, 10% at the second, and 14% at the third, while the negative predictive value was 100% across all follow-up visits. Conclusions: The E6/E7 mRNA test appears to be an effective tool for ruling out recurrence after treatment for HSIL/CIN lesions in HPV-immunized patients. Full article
12 pages, 1172 KiB  
Article
The Immunogenicity of Glutaraldehyde Inactivated PTx Is Determined by the Quantity of Neutralizing Epitopes
by Xi Wang, Xinyue Cui, Chongyang Wu, Ke Tao, Shuyuan Pan and Wenming Wei
Vaccines 2025, 13(8), 817; https://doi.org/10.3390/vaccines13080817 (registering DOI) - 31 Jul 2025
Viewed by 157
Abstract
Background/Objectives: Chemically or genetically detoxified pertussis toxin (PTx) is a crucial antigen component of the acellular pertussis vaccine. Chemical detoxification using glutaraldehyde generally causes significant structural changes to the toxin. However, how these structural changes in PTx affect its antigenic properties remains unclear. [...] Read more.
Background/Objectives: Chemically or genetically detoxified pertussis toxin (PTx) is a crucial antigen component of the acellular pertussis vaccine. Chemical detoxification using glutaraldehyde generally causes significant structural changes to the toxin. However, how these structural changes in PTx affect its antigenic properties remains unclear. Additionally, there is limited knowledge regarding how many alterations in antigenic properties impact immunogenicity. Methods: To investigate the impact of structural changes on antigenic properties, we developed a sandwich ELISA to quantify the neutralizing epitopes on PTx. Subsequently, we analyzed different PTx toxoid (PTd) preparations with the assay. Additionally, we assessed the immunogenicity of various acellular pertussis vaccine candidates containing these PTd preparations. Finally, the assay was applied to evaluate the consistency of commercial batches of PTx and PTd intermediates. Results: The assay demonstrated reasonable specificity, accuracy, and precision, and it was sensitive enough to quantify variations in neutralizing epitopes among different PTd samples that shared the same protein concentration. Importantly, we found a positive correlation between the number of neutralizing epitopes in detoxified PTx and its immunogenicity, indicating that the amount of neutralizing epitopes present determines the immunogenicity of glutaraldehyde-inactivated PTx. Moreover, commercial batches of PTx and PTd intermediates exhibited minor variations in neutralizing epitopes. Conclusions: These findings have significant implications for developing acellular pertussis vaccines as they highlight the importance of preserving the neutralizing epitopes of PTx during detoxification to ensure the vaccine’s effectiveness. This assay is also valuable for the quality control of PTd as it more accurately represents the actual antigenic changes of PTx. Full article
(This article belongs to the Special Issue New Technology for Vaccines and Vaccine-Preventable Diseases)
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11 pages, 262 KiB  
Article
Use of a Peer Equity Navigator Intervention to Increase Access to COVID-19 Vaccination Among African, Caribbean and Black Communities in Canada
by Josephine Etowa, Ilene Hyman and Ubabuko Unachukwu
Int. J. Environ. Res. Public Health 2025, 22(8), 1195; https://doi.org/10.3390/ijerph22081195 - 31 Jul 2025
Viewed by 145
Abstract
African, Caribbean, and Black (ACB) communities face increased COVID-19 morbidity and mortality, coupled with significant barriers to vaccine acceptance and uptake. Addressing these challenges requires innovative, multifaceted strategies. Peer-led interventions, grounded in critical health literacy (CHL) and critical racial literacy (CRL), and integrating [...] Read more.
African, Caribbean, and Black (ACB) communities face increased COVID-19 morbidity and mortality, coupled with significant barriers to vaccine acceptance and uptake. Addressing these challenges requires innovative, multifaceted strategies. Peer-led interventions, grounded in critical health literacy (CHL) and critical racial literacy (CRL), and integrating collaborative equity learning processes, can enhance community capacity, empowerment, and health outcomes, contributing to long-term health equity. This paper describes and presents the evaluative outcomes of a peer-led intervention aimed at enhancing COVID-19 vaccine confidence and acceptance. The Peer-Equity Navigator (PEN) intervention consisted of a specialized training curriculum grounded in CHL and CRL. Following training, PENs undertook a 5-month practicum in community or health settings, engaging in diverse outreach and educational activities to promote vaccine literacy in ACB communities. The evaluation utilized a modified Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework, using quantitative and qualitative methods to collect data. Sources of data included tracking records with community feedback, and a PEN focus group, to assess program feasibility, outreach, and effectiveness. From 16 September 2022, to 28 January 2023, eight trained PENs conducted 56+ community events, reaching over 1500 community members. Both PENs and community members reported high engagement, endorsing peer-led, community-based approaches and increased vaccine literacy. The PEN approach proves feasible, acceptable, and effective in promoting positive health behaviors among ACB communities. This intervention has clear implications for health promotion practice, policy, and research in equity-deserving communities, including immigrants and refugees, who also face multiple and intersecting barriers to health information and care. Full article
13 pages, 2893 KiB  
Article
Vaccine Attitudes, Knowledge, and Confidence Among Nursing, Pediatric Nursing, and Midwifery Undergraduate Students in Italy
by Ersilia Buonomo, Daniele Di Giovanni, Gaia Piunno, Stefania Moramarco, Giuliana D’Elpidio, Ercole Vellone, Enkeleda Gjini, Mariachiara Carestia, Cristiana Ferrari and Luca Coppeta
Vaccines 2025, 13(8), 813; https://doi.org/10.3390/vaccines13080813 (registering DOI) - 30 Jul 2025
Viewed by 159
Abstract
Background: Vaccine hesitancy (VH) represents a growing concern among healthcare professionals and students, potentially undermining public health efforts. Nursing, pediatric nursing, and midwifery students are future vaccinators and educators, making it essential to understand their attitudes, knowledge, and confidence toward vaccination. This study [...] Read more.
Background: Vaccine hesitancy (VH) represents a growing concern among healthcare professionals and students, potentially undermining public health efforts. Nursing, pediatric nursing, and midwifery students are future vaccinators and educators, making it essential to understand their attitudes, knowledge, and confidence toward vaccination. This study aims to assess vaccine-related perceptions and behaviors among these student populations in an Italian university. Methods: A cross-sectional survey was conducted between November 2022 and February 2024 at the University of Rome “Tor Vergata”. A structured, anonymous questionnaire, including the Vaccination Attitudes Examination (VAX) scale, vaccine knowledge items, and sources of information, was administered to students in nursing (n = 205), pediatric nursing (n = 46), and midwifery (n = 21). Statistical analyses included descriptive statistics, ANOVA, post hoc tests, and Mann–Whitney U tests. Results: Among the 272 participants, 20.6% reported refusing at least one recommended vaccine, and 18.4% delayed vaccination for non-medical reasons. Vaccine knowledge and confidence increased significantly with academic progression (p < 0.001). Midwifery students showed both the highest concern for long-term vaccine effects and the greatest confidence in vaccine safety. Institutional and scientific sources were the most trusted, though traditional and non-institutional media also influenced perceptions, particularly among midwifery students. Conclusions: Despite high COVID-19 vaccine uptake, VH persists among health professional students. Discipline-specific patterns highlight the need for early, targeted educational strategies to enhance vaccine literacy and reduce hesitancy. Tailored training may empower future professionals to become informed and credible advocates for vaccination. Full article
(This article belongs to the Special Issue Acceptance and Hesitancy in Vaccine Uptake: 2nd Edition)
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22 pages, 1272 KiB  
Review
Pharmacy Technicians in Immunization Services: Mapping Roles and Responsibilities Through a Scoping Review
by Carolina Valeiro, Vítor Silva, Jorge Balteiro, Diane Patterson, Gilberto Bezerra, Karen Mealiff, Cristiano Matos, Ângelo Jesus and João Joaquim
Healthcare 2025, 13(15), 1862; https://doi.org/10.3390/healthcare13151862 - 30 Jul 2025
Viewed by 161
Abstract
Background: Pharmacy technicians are increasingly involved in immunization services, enhancing vaccine accessibility and reducing pharmacies’ workload. This scoping review aims to (1) provide a comprehensive overview of pharmacy technicians’ involvement in immunization services across various healthcare settings and countries, and (2) conduct a [...] Read more.
Background: Pharmacy technicians are increasingly involved in immunization services, enhancing vaccine accessibility and reducing pharmacies’ workload. This scoping review aims to (1) provide a comprehensive overview of pharmacy technicians’ involvement in immunization services across various healthcare settings and countries, and (2) conduct a comparative analysis of training curricula for pharmacy technicians on immunization. Methods: A scoping review was conducted following the Arksey and O’Malley framework. A comprehensive search of the PubMed and Scopus databases was performed using keywords and MeSH terms such as “pharmacy technician(s)”, “immunization”, “vaccination”, “role”, and “involvement”. Studies included assessed pharmacy technicians’ roles in vaccine administration, training, and public health outcomes. Descriptive and thematic analyses were used to synthesize the findings. In addition, a supplementary analysis of immunization training curricula was conducted, reviewing programs from different countries to identify similarities, differences, and gaps in course structure, content, and delivery formats. Lastly, a comprehensive toolkit was developed, offering guidelines intended to facilitate the implementation of immunization training programs. Results: A total of 35 articles met the inclusion criteria, primarily from the United States of America (n = 30), Canada (n = 2), Ethiopia (n = 1), Denmark (n = 1) and United Kingdom (n = 1). The findings indicate that pharmacy technicians contribute significantly to vaccine administration, patient education, and workflow optimization, particularly in community pharmacies. The COVID-19 pandemic accelerated their involvement in immunization programs. Key challenges include regulatory barriers, a lack of standardized training, and resistance from other healthcare professionals. Facilitators include legislative support (e.g., the PREP Act), structured training programs, and collaborative pharmacist–technician models. Conclusions: Pharmacy technicians can play a vital role in expanding immunization services, improving vaccine uptake, and reducing pharmacist workload. Addressing regulatory inconsistencies, enhancing training, and fostering interprofessional collaboration are crucial for their effective integration of immunization programs. Since immunization by pharmacy technicians is not yet allowed in many EU countries, this review will provide a foundational basis to address their potential to support the healthcare workforce and improve access to immunization services. Full article
(This article belongs to the Special Issue Policy Interventions to Promote Health and Prevent Disease)
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15 pages, 288 KiB  
Systematic Review
Interventions to Improve Vaccination Uptake Among Adults: A Systematic Review and Meta-Analysis
by Anelisa Jaca, Lindi Mathebula, Thobile Malinga, Kimona Rampersadh, Masibulele Zulu, Ameer Steven-Jorg Hohlfeld, Charles Shey Wiysonge, Julie C. Jacobson Vann and Duduzile Ndwandwe
Vaccines 2025, 13(8), 811; https://doi.org/10.3390/vaccines13080811 (registering DOI) - 30 Jul 2025
Viewed by 207
Abstract
Background: Immunization is a highly effective intervention for controlling over 20 life-threatening infectious diseases, significantly reducing both morbidity and mortality rates. One notable achievement in vaccination efforts was the global eradication of smallpox, which the World Health Assembly declared on 8 May 1980. [...] Read more.
Background: Immunization is a highly effective intervention for controlling over 20 life-threatening infectious diseases, significantly reducing both morbidity and mortality rates. One notable achievement in vaccination efforts was the global eradication of smallpox, which the World Health Assembly declared on 8 May 1980. Additionally, there has been a remarkable 99.9% reduction in wild poliovirus cases since 1988, decreasing from more than 350,000 cases that year to just 30 cases in 2022. Objectives: The objective of this review was to assess the effects of various interventions designed to increase vaccination uptake among adults. Search Methods: A thorough search was conducted in the CENTRAL, Embase Ovid, Medline Ovid, PubMed, Web of Science, and Global Index Medicus databases for primary studies. This search was conducted in August 2021 and updated in November 2024. Selection Criteria: Randomized trials were eligible for inclusion in this review, regardless of publication status or language. Data Analysis: Two authors independently screened the search outputs to select potentially eligible studies. Risk ratios (RR) with 95% confidence intervals (CI) were calculated for each randomized controlled trial (RCT). A meta-analysis was conducted using a random-effects model, and the quality of the evidence was assessed using the GRADE approach. Main Results: A total of 35 randomized controlled trials met the inclusion criteria and were included in this review, with the majority conducted in the United States. The interventions targeted adults aged 18 and older who were eligible for vaccination, involving a total of 403,709 participants. The overall pooled results for interventions aimed at increasing influenza vaccination showed a risk ratio of 1.41 (95% CI: 1.15, 1.73). Most studies focused on influenza vaccination (18 studies), while the remaining studies examined various other vaccines, including those for hepatitis A, COVID-19, hepatitis B, pneumococcal disease, tetanus, diphtheria, pertussis (Tdap), herpes zoster, and human papillomavirus (HPV). The results indicate that letter reminders were slightly effective in increasing influenza vaccination uptake compared to the control group (RR: 1.75, 95% CI: 0.97, 1.16; 6 studies; 161,495 participants; low-certainty evidence). Additionally, participants who received education interventions showed increased levels of influenza vaccination uptake compared to those in the control group (RR: 1.88, 95% CI: 0.61, 5.76; 3 studies; 1318 participants; low-certainty evidence). Furthermore, tracking and outreach interventions also led to an increase in influenza vaccination uptake (RR: 1.87, 95% CI: 0.78, 4.46; 2 studies; 33,752 participants; low-certainty evidence). Conclusions: Letter reminders and educational interventions targeted at recipients are effective in increasing vaccination uptake compared to control groups. Full article
11 pages, 1528 KiB  
Brief Report
End-of-Season Influenza Vaccine Effectiveness Against Laboratory-Confirmed Influenza in Outpatient Settings, Beijing, China: A Test-Negative Design
by Jiaojiao Zhang, Zhaomin Feng, Ying Shen, Weixian Shi, Ying Sun, Jiachen Zhao, Dan Wu, Jia Li, Chunna Ma, Wei Duan, Jiaxin Ma, Yingying Wang, Lu Zhang, Xiaodi Hu, Quanyi Wang, Daitao Zhang and Peng Yang
Vaccines 2025, 13(8), 809; https://doi.org/10.3390/vaccines13080809 - 30 Jul 2025
Viewed by 242
Abstract
This study aimed to estimate the end-of-season influenza vaccine effectiveness (VE) for the 2024/25 season in Beijing, China. Methods: We used a test-negative design (TND) to assess influenza VE among outpatients with influenza-like illness (ILI) enrolled through the influenza virological surveillance in sentinel [...] Read more.
This study aimed to estimate the end-of-season influenza vaccine effectiveness (VE) for the 2024/25 season in Beijing, China. Methods: We used a test-negative design (TND) to assess influenza VE among outpatients with influenza-like illness (ILI) enrolled through the influenza virological surveillance in sentinel hospitals in Beijing from week 44, 2024 to week 14, 2025. Cases were ILI patients who tested positive for influenza; controls were those who tested negative. Results: Among 18,405 ILI patients tested, 3690 (20.0%) were positive for influenza, with A(H1N1)pdm09 as the predominant strain (98.9%). The overall influenza vaccination coverage was 12.4%. Adjusted VE was 48.3% (95%CI: 40.4%–55.3%) against any influenza and 48.2% (95%CI: 40.3%–55.1%) against A(H1N1)pdm09, with the highest VE observed in adults aged 18–59 years (79.0%). The adjusted VE was similar for those vaccinated in 2023/24 only (53.1%) or both 2023/24 and 2024/25 seasons (50.8%), but lower for those vaccinated only in the 2024/25 season (48.5%). The adjusted VE was higher during the epidemic period (52.5%) than in the pre-epidemic (48.1%) and post-epidemic (35.3%) periods. Conclusions: Our findings indicate moderate VE against laboratory-confirmed influenza, especially A(H1N1)pdm09, during the end of the 2024/25 season in Beijing, China. Influenza vaccination provided protective effects across different epidemic periods. These timely estimates support ongoing public health communication and immunization strategies. Full article
(This article belongs to the Section Vaccine Advancement, Efficacy and Safety)
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12 pages, 691 KiB  
Article
A Novel Approach to Estimate the Impact of PCV20 Immunization in Children by Incorporating Indirect Effects to Generate the Number Needed to Vaccinate
by Mark H. Rozenbaum, Maria J. Tort, Blair Capitano, Ruth Chapman, Desmond Dillon-Murphy, Benjamin M. Althouse and Alejandro Cane
Vaccines 2025, 13(8), 805; https://doi.org/10.3390/vaccines13080805 - 29 Jul 2025
Viewed by 248
Abstract
Background/Objectives: The number needed to vaccinate (NNV) is a metric commonly used to evaluate the public health impact of a vaccine as it represents the number of individuals that must be vaccinated to prevent one case of disease. Traditional calculations may underestimate vaccine [...] Read more.
Background/Objectives: The number needed to vaccinate (NNV) is a metric commonly used to evaluate the public health impact of a vaccine as it represents the number of individuals that must be vaccinated to prevent one case of disease. Traditional calculations may underestimate vaccine benefits by neglecting indirect effects and duration of protection (DOP), resulting in NNV overestimation. This study evaluated the NNV for the pediatric 20-valent pneumococcal conjugate (PCV20) US immunization program, as compared to PCV13, with a unique approach to NNV. Methods: A multi-cohort, population-based Markov model accounting for indirect effects was employed to calculate the NNV of PCV20 to avert a case of pneumococcal disease, invasive pneumococcal disease (IPD), hospitalized non-bacteremic pneumonia (NBP), ambulatory NBP, and otitis media (OM), as well as to prevent antibiotic-resistant cases and antibiotic prescriptions. Results: The mean NNV over a 25-year time horizon to prevent one case of pneumococcal disease was 6, with NNVs of 854 for IPD, 106 for hospitalized NBP, 25 for outpatient NBP, and 9 for OM, 11 for a course of antibiotic, and 4 for resistant disease. The mean NNV per year decreased over time, reflecting the DOP and increasing indirect effects over time. Conclusions: This study presents a novel approach to NNVs and shows that relatively few vaccinations are required to prevent disease. The decrease in NNV over time highlights the necessity of including DOP and indirect effects in NNV calculations, ensuring a more realistic assessment of a vaccine’s impact. Full article
(This article belongs to the Special Issue Estimating Vaccines' Value and Impact)
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26 pages, 635 KiB  
Review
Decoding Immunodeficiencies with Artificial Intelligence: A New Era of Precision Medicine
by Raffaele Sciaccotta, Paola Barone, Giuseppe Murdaca, Manlio Fazio, Fabio Stagno, Sebastiano Gangemi, Sara Genovese and Alessandro Allegra
Biomedicines 2025, 13(8), 1836; https://doi.org/10.3390/biomedicines13081836 - 28 Jul 2025
Viewed by 378
Abstract
Primary and secondary immunodeficiencies comprise a wide array of illnesses marked by immune system abnormalities, resulting in heightened vulnerability to infections, autoimmunity, and cancers. Notwithstanding progress in diagnostic instruments and an enhanced comprehension of the underlying pathophysiology, delayed diagnosis and underreporting persist as [...] Read more.
Primary and secondary immunodeficiencies comprise a wide array of illnesses marked by immune system abnormalities, resulting in heightened vulnerability to infections, autoimmunity, and cancers. Notwithstanding progress in diagnostic instruments and an enhanced comprehension of the underlying pathophysiology, delayed diagnosis and underreporting persist as considerable obstacles. The implementation of artificial intelligence into clinical practice has surfaced as a viable method to enhance early detection, risk assessment, and management of immunodeficiencies. Recent advancements illustrate how artificial intelligence-driven models, such as predictive algorithms, electronic phenotyping, and automated flow cytometry analysis, might enable early diagnosis, minimize diagnostic delays, and enhance personalized treatment methods. Furthermore, artificial intelligence-driven immunopeptidomics and phenotypic categorization are enhancing vaccine development and biomarker identification. Successful implementation necessitates overcoming problems associated with data standardization, model validation, and ethical issues. Future advancements will necessitate a multidisciplinary partnership among physicians, data scientists, and governments to effectively use the revolutionary capabilities of artificial intelligence, therefore ushering in an age of precision medicine in immunodeficiencies. Full article
(This article belongs to the Section Immunology and Immunotherapy)
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11 pages, 284 KiB  
Article
Is Inhaled Colostrum as Effective as Inhaled Lavender Essential Oil for Pain Control in Neonatal Frenotomies? A Prospective, Randomized Clinical Trial
by Silvia Maya-Enero, Júlia Candel-Pau, Beatriz Valle-Del Barrio, Montserrat Fàbregas-Mitjans, Sandra Prieto-Paja and María Ángeles López-Vílchez
Children 2025, 12(8), 982; https://doi.org/10.3390/children12080982 - 26 Jul 2025
Viewed by 231
Abstract
Background/Objectives: Neonatal pain must be treated due to its potential short- and long-term adverse effects. A frenotomy is a painful procedure where common strategies to relieve pain (oral sucrose solutions and sucking) cannot be used because the technique is performed on the tongue. [...] Read more.
Background/Objectives: Neonatal pain must be treated due to its potential short- and long-term adverse effects. A frenotomy is a painful procedure where common strategies to relieve pain (oral sucrose solutions and sucking) cannot be used because the technique is performed on the tongue. Lavender essential oil (LEO) is useful in treating pain during blood sampling, heel punctures, vaccination, and frenotomies. We aimed to determine whether smelling colostrum had similar effects as inhaled LEO during frenotomies. Methods: A prospective, randomized clinical trial was carried out with neonates who underwent a frenotomy for ankyloglossia between September 2023 and June 2024. We assessed pain using the NIPS score, heart rate, oxygen saturation, and crying time. After obtaining parental informed consent, we randomized patients into experimental and control groups. In both groups, we performed swaddling, administered 1 mL of oral sucrose, and let the newborn suck for 2 min. In the experimental group, we placed a gauze pad with two drops of colostrum, whereas in the control group, we used one drop of LEO 2 cm under the neonate’s nose prior to and during the frenotomy. Results: We enrolled 142 patients (71 experimental cases and 71 controls). The experimental group showed lower crying times (28.0 vs. 40.2 s, p = 0.03). Both groups showed similar NIPS scores (1.4 vs. 1.5, p = 0.28). We observed no side effects in either of the groups. Conclusions: Inhaled colostrum and LEO help relieve pain in neonates who undergo a frenotomy for ankyloglossia and have no side effects. Aromatherapy with colostrum may decrease crying time during the frenotomy. Full article
(This article belongs to the Section Pediatric Neonatology)
16 pages, 777 KiB  
Communication
The Platform Readiness Dashboard: A Tool for Evaluating Vaccine Platform Suitability for a Rapid Response to Epidemic and Pandemic Threats
by Ramin Sabet-Azad, Catherine Hoath, Nicole Bézay and Anna Särnefält
Vaccines 2025, 13(8), 793; https://doi.org/10.3390/vaccines13080793 - 26 Jul 2025
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Abstract
Rapid vaccine availability is essential for effective epidemic and pandemic response. Building on the Coalition for Epidemic Preparedness Innovations (CEPI) 100 Days Mission, which aims to have new vaccines ready for initial authorization and manufacturing at scale within 100 days of recognition of [...] Read more.
Rapid vaccine availability is essential for effective epidemic and pandemic response. Building on the Coalition for Epidemic Preparedness Innovations (CEPI) 100 Days Mission, which aims to have new vaccines ready for initial authorization and manufacturing at scale within 100 days of recognition of a pandemic pathogen, the CEPI has developed a Chemistry, Manufacturing and Controls (CMC) Rapid Response Framework to define technical and logistical CMC requirements to enable rapid vaccine availability. Central to this framework is the availability of adaptable vaccine platforms that can be readily tailored to emerging pathogens. To support strategic decision-making and identify gaps in platform capabilities, CEPI has created the Platform Readiness Dashboard. This tool provides a structured, multi-dimensional initial assessment of platform maturity across six key categories: Adaptability, Compatibility, Suitability, Regulatory, Manufacturing, and Facility Readiness. Each category includes specific technical and operational considerations scored using a color-coded system to reflect outbreak response readiness level. This Dashboard aims to enable vaccine developers, manufacturers, funders, and outbreak response teams to evaluate platform strengths and limitations at any given time, informing funding, preparedness and response activities. By offering a dynamic view of essential platform readiness indicators, the dashboard can communicate progress supporting faster responses to future health emergencies. Full article
(This article belongs to the Special Issue Estimating Vaccines' Value and Impact)
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Review
The Number Needed to Immunize (NNI) to Assess the Benefit of a Prophylaxis Intervention with Monoclonal Antibodies Against RSV
by Sara Boccalini, Veronica Gironi, Primo Buscemi, Paolo Bonanni, Barbara Muzii, Salvatore Parisi, Marta Borchiellini and Angela Bechini
Vaccines 2025, 13(8), 791; https://doi.org/10.3390/vaccines13080791 - 25 Jul 2025
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Abstract
Introduction: Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections in infants and children, as well as hospitalizations for respiratory infections in the pediatric population, representing a significant public health concern. Nirsevimab, a long-acting anti-RSV monoclonal antibody, has recently [...] Read more.
Introduction: Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections in infants and children, as well as hospitalizations for respiratory infections in the pediatric population, representing a significant public health concern. Nirsevimab, a long-acting anti-RSV monoclonal antibody, has recently been approved by the European Medicines Agency (EMA). The aim of this study is to assess the utility of certain parameters, such as the Number Needed to Immunize (NNI), in supporting decision-makers regarding the introduction of nirsevimab as a universal prophylactic measure. Methods: A literature review was conducted to identify the definition and application of the NNI in the context of infectious disease prevention. The following online databases were consulted: Scopus, MEDLINE, Google Scholar, Web of Science, and Cochrane Library. The search was restricted to English-language texts published between 1 January 2000 and 30 January 2025. Results: The NNI represents the number of individuals who need to be immunized to prevent clinical outcomes such as medical visits and hospitalizations caused by infectious diseases. Six studies were identified that utilized this parameter to outline the benefits of immunization and describe the advantages of using monoclonal antibodies for RSV disease. Finelli and colleagues report that to prevent one RSV-related hospitalization, 37–85 infants aged 0–5 months and 107–280 infants aged 6–11 months would need to be immunized with long-acting anti-RSV antibodies. A recent study by Mallah et al. on the efficacy of nirsevimab estimates that the NNI required to prevent one RSV-related hospitalization is 25 infants. Studies by Francisco and O’Leary report NNI values of 82 and 128 infants, respectively, to prevent one RSV-related hospitalization with nirsevimab. Mallah et al. describe NNI as a metric useful to quantify the immunization effort needed to prevent a single RSV hospitalization. A recent Italian study reports that 35 infants need to be immunized to prevent one hospitalization due to RSV-LRTI and 3 infants need to be immunized to prevent one primary care visit due to RSV-LRTI. The studies indicate that the NNI for anti-RSV monoclonal antibodies is lower than the corresponding Number Needed to Vaccinate (NNV) for vaccines already included in national immunization programs. The main limitations of using this parameter include the absence of a shared threshold for interpreting results and the lack of consideration for the indirect effects of immunization on the population. Conclusions: The NNI is an easily understandable tool that can be used to convey the value of an immunization intervention to a variety of stakeholders, thereby supporting public health decision-making processes when considered in association with the uptake of the preventative strategy. At the current status, the estimated NNI of monoclonal antibodies against RSV results favourable and confirms the use in the first year of life for the prevention of RSV disease. Full article
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