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20 pages, 2293 KiB  
Article
An Evaluation of the Safety, Immunogenicity, and Protective Efficacy of a Combined Diphtheria–Tetanus–Acellular Pertussis, Haemophilus influenzae Type b, and ACYW135 Meningococcal Conjugate Vaccine in Murine and Rat Models
by Xiuwen Sui, Zhujun Shao, Yuanyuan Ji, Hairui Wang, Qingfu Xu, Bochao Wei, Zhuojun Duan, Chang Wang, Ying Yang, Jiayu Zhao and Tao Zhu
Vaccines 2025, 13(7), 724; https://doi.org/10.3390/vaccines13070724 - 3 Jul 2025
Viewed by 546
Abstract
Background: The combined diphtheria–tetanus–acellular pertussis (three-component), Haemophilus influenzae type b (Hib, conjugate), and ACYW135 meningococcal (conjugate) vaccine (DTaP-Hib-MCV4) offers a promising alternative to single-component vaccines, potentially simplifying immunization schedules and improving vaccination coverage. Methods: We evaluated the safety, immunogenicity, and protective [...] Read more.
Background: The combined diphtheria–tetanus–acellular pertussis (three-component), Haemophilus influenzae type b (Hib, conjugate), and ACYW135 meningococcal (conjugate) vaccine (DTaP-Hib-MCV4) offers a promising alternative to single-component vaccines, potentially simplifying immunization schedules and improving vaccination coverage. Methods: We evaluated the safety, immunogenicity, and protective efficacy of DTaP-Hib-MCV4 in animal models. Acute and long-term toxicity studies were conducted in Sprague-Dawley (SD) rats with equal numbers of male and female animals. Immunogenicity was assessed in female NIH mice and SD rats using a three-dose regimen at 14-day intervals. Orbital blood was collected 14 days post-immunization to measure IgG titers against pertussis, diphtheria, tetanus, Hib, and meningococcal antigens. The protective efficacy was determined using potency tests for the pertussis, diphtheria, and tetanus components; passive protection studies for Hib; and serum bactericidal antibody (SBA) titers against A/C/Y/W135 meningococcal serogroups. Results: Acute and repeated-dose toxicity studies in SD rats showed no signs of abnormal toxicity or irritation at either high (three doses/rat) or low (one dose/rat) doses levels. The no-observed-adverse-effect level (NOAEL) for DTaP-Hib-MCV4 was established at three doses/rat after 8 weeks of repeated intramuscular administration and a 4-week recovery period. Specific IgG antibodies against all the vaccine components were detected in animal sera at both one and three doses/rat, with no evidence of immunotoxicity. Following two-dose primary immunization in murine models, the combined vaccine elicited robust antigen-specific antibody responses, with geometric mean titers (GMTs) as follows: 1,280,000 for pertussis toxin (PT); 761,093 for filamentous hemagglutinin (FHA); 1,159,326 for pertactin (PRN); 1,659,955 for diphtheria toxoid (DT); 1,522,185 for tetanus toxoid (TT); 99 for Haemophilus influenzae type b (Hib); and 25,600, 33,199, 8300, and 9051 for serogroups A, C, Y, and W135 of Neisseria meningitidis, respectively. In the rat models, three-dose primary immunization also elicited robust antigen-specific antibody responses. Protection studies demonstrated efficacy against pertussis, tetanus toxin, and diphtheria toxin challenges. In the Hib challenge study, none of the 10 animals given anti-DTaP-Hib-MCV4 antiserum developed bacteremia after the live Hib challenge (vs. 5814/0.1 mL in the negative control, p < 0.001). In addition, the SBA titers against meningococcal serogroups exceeded the protective threshold (≥1:8) in 92.2% of the immunized mice and 100% of the immunized rats. Crucially, the combined vaccine induced potent immune responses and protective efficacy, with antibody levels and protection against each component antigen comparable to or greater than those of the individual components: DTaP, Hib, and MCV4. Conclusions: These findings demonstrate that the DTaP-Hib-MCV4 combined vaccine is both safe and immunogenic, supporting its potential as a viable alternative to individual vaccines. This combined vaccine may streamline immunization programs and enhance vaccination coverage. Full article
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14 pages, 651 KiB  
Article
Safety and Efficacy of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus Type B Infections in Children with Systemic Juvenile Idiopathic Arthritis: Prospective Cohort Study
by Ekaterina Alexeeva, Tatyana Dvoryakovskaya, Dmitry Kudlay, Anna Fetisova, Ivan Kriulin, Elizaveta Krekhova, Anna Kabanova, Vladimir Labinov, Elizaveta Labinova and Mikhail Kostik
Vaccines 2025, 13(6), 644; https://doi.org/10.3390/vaccines13060644 - 15 Jun 2025
Viewed by 635
Abstract
Background: The introduction of biological drugs into clinical practice for the treatment of children with systemic juvenile idiopathic arthritis (sJIA) allows disease control but increases the risk of infectious events. Infectious events cause immunosuppressive therapy interruptions, leading to disease flare and life-threatening [...] Read more.
Background: The introduction of biological drugs into clinical practice for the treatment of children with systemic juvenile idiopathic arthritis (sJIA) allows disease control but increases the risk of infectious events. Infectious events cause immunosuppressive therapy interruptions, leading to disease flare and life-threatening complications, namely macrophage activation syndrome. Our study aimed to evaluate the efficacy and safety of simultaneous vaccination against pneumococcal and Haemophilus influenzae type b (Hib) in children with sJIA. Methods: This study included 100 sJIA patients receiving immunosuppressive therapy who were simultaneously vaccinated against pneumococcal and Haemophilus influenzae type b (Hib) infections. The mean age of disease onset was 5.5 years. The median age at vaccination was 10 ± 4.5 years. Clinical and laboratory parameters of sJIA activity, immunization efficacy, and safety, including anti-SP and anti-Hib IgG antibodies, as well as all vaccination-related adverse events (AEs), were recorded in every patient before, 3 weeks after, and 6 months after vaccination. Results: At the time of vaccination, 29% of patients did not meet the criteria for the inactive disease stage, as defined by C. Wallace: active joints were present in 34.5% of patients, systemic manifestations (rash and/or fever) were present in 41.3%, and 24.2% of patients had solely inflammatory laboratory activity. The protective titer of anti-SP and anti-Hib IgG antibodies was detected in the majority of patients 3 weeks after vaccination (100% and 93%, respectively). The results remained unchanged (99% and 92%, respectively) for 6 months of follow-up, compared to the baseline (91% and 37%, p = 0.000001). Anti-SP IgG and anti-Hib titers raised from 48.3 (18.2; 76.5) and 0.64 (0.3; 3.2) U/mL at the baseline to 103.5 (47.3; 185.4) and 4 (3.5; 4.2) U/mL at D22 and 105 (48.7; 171.8) and 4 (3.8; 4) U/mL (EOS), respectively. Immunosuppressive therapy regimens (combined therapy or biological disease-modifying antirheumatic drug monotherapy) did not influence the immunogenic efficacy of vaccination. The incidence of infectious complications (p = 0.0000001) and antibiotic prescriptions (p = 0.0000001) decreased by more than two times, to 29.9 and 13.8 events per 100 patient months, respectively, within 6 months after vaccination—the average duration of acute infectious events was reduced by five times after immunization (p = 0.0000001). Vaccination did not lead to disease flare: the number of patients with active joints decreased by half compared to the baseline, and the number of patients with systemic manifestations decreased by six times. All vaccine-associated adverse events were considered mild and resolved within 1–2 days. Conclusions: Simultaneous vaccination against pneumococcal and Hib infections in sJIA children is an effective and safe tool that reduces the number and duration of infectious events and does not cause disease flare-ups. Full article
(This article belongs to the Special Issue Pneumococcal Vaccines: Current Status and Future Prospects)
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21 pages, 1871 KiB  
Article
The Effects of Patients’ Health Information Behaviors on Shared Decision-Making: Evaluating the Role of Patients’ Trust in Physicians
by Mingming Song, Joel Elson, Christian Haas, Sharon N. Obasi, Xinyu Sun and Dhundy Bastola
Healthcare 2025, 13(11), 1238; https://doi.org/10.3390/healthcare13111238 - 24 May 2025
Viewed by 699
Abstract
Background/Objectives: The availability of accessible health information outside of traditional healthcare settings has transformed patient engagement in shared decision-making (SDM) with healthcare providers. However, the challenge of navigating misinformation complicates SDM, highlighting the critical role of trust, especially when patient-achieved information conflicts [...] Read more.
Background/Objectives: The availability of accessible health information outside of traditional healthcare settings has transformed patient engagement in shared decision-making (SDM) with healthcare providers. However, the challenge of navigating misinformation complicates SDM, highlighting the critical role of trust, especially when patient-achieved information conflicts with professional advice. This study examines the association between patients’ health information behavior (HIB) and SDM, emphasizing the role of patients’ trust in healthcare providers. Methods: Utilizing data from the Health Information National Trends Survey (HINTS), this research explores how trust mediates the relationship between HIB and SDM. We conducted factor analysis, mediation analysis, and moderated mediation analysis to assess our hypotheses. Results: Factor analysis identified two main HIB dimensions: emotional responses and utilization of social media. Emotional responses positively influenced SDM, enhancing trust and decision-making involvement. In contrast, utilization of social media negatively influenced SDM through decreased trust. Mediation analysis confirmed trust in physicians as a crucial mediator, particularly when emotional responses foster trust and engagement. Moderated mediation showed that high healthcare quality amplified the positive mediation effects of trust, underscoring its role in effective SDM. Conclusions: This study highlights the significant role of trust in enhancing patient engagement in SDM through HIB. High perceived healthcare quality also strengthens trust, improving SDM outcomes. The study contributes to the literature by providing a comprehensive analysis of the interplay between HIB, trust, and SDM, suggesting that enhancing patient-centered care requires fostering trusted patient–physician relationships. Full article
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18 pages, 1035 KiB  
Article
Adverse Events Following Haemophilus influenzae Type b (Hib) Monovalent Vaccines in Zhejiang Province, China, from 2017 to 2023
by Xuejiao Pan, Yaping Chen, Hui Liang, Linzhi Shen and Xiaohua Qi
Vaccines 2025, 13(4), 349; https://doi.org/10.3390/vaccines13040349 - 25 Mar 2025
Viewed by 875
Abstract
Background: The Haemophilus influenzae type b (Hib) vaccination has well-established safety and efficacy in preventing Hib and reducing related morbidity and mortality worldwide. China has a high disease burden of Hib yet a low coverage rate of Hib vaccines and remains the only [...] Read more.
Background: The Haemophilus influenzae type b (Hib) vaccination has well-established safety and efficacy in preventing Hib and reducing related morbidity and mortality worldwide. China has a high disease burden of Hib yet a low coverage rate of Hib vaccines and remains the only WHO member country not including the Hib vaccine in its National Immunization Program (NIP), partly due to insufficient surveillance data on its safety. This study analyzed all adverse events following immunization (AEFIs) after Hib monovalent vaccination in Zhejiang Province from 2017 to 2023 to provide evidence for formulating relevant immunization strategies. Methods: Hib vaccine-related AEFIs in Zhejiang Province from 1 January 2017, to 31 December 2023, were collected through the Chinese National AEFI Information System (CNAEFIS) for a descriptive epidemiological analysis. Results: From 2017 to 2023, a total of 1740 Hib vaccine-related AEFIs were reported (incidence rate: 63.01/100,000 doses) (95%CI: 60.12/100,000 doses–66.04/100,000 doses), including 1577 common adverse reactions (57.10/100,000 doses) (95%CI: 54.35/100,000 doses–59.99/100,000 doses), 139 rare adverse reactions (5.03/100,000 doses) (95%CI: 4.26/100,000 doses–5.94/100,000 doses), and 24 coincidental events (0.87/100,000 doses) (95%CI: 0.58/100,000 doses–1.29/100,000 doses). Most of the AEFIs were common adverse reactions that manifested mainly as fever, injection site redness and swelling, and crying. AEFIs were more likely to occur in male participants under the age of one, in summer and autumn, and during the booster immunity stage. The top three regions with the highest reported incidence rates of AEFIs were Jiaxing City (86.61/100,000 doses) (95%CI: 74.44/100,000 doses–100.77/100,000 doses), Hangzhou City (81.29/100,000 doses) (95%CI: 72.56/100,000 doses–91.07/100,000 doses), and Taizhou City (66.62/100,000 doses) (95%CI: 58.24/100,000 doses–76.21/100,000 doses). Conclusions: Our findings provide preliminary evidence of the safety profile of the Hib vaccine at a provincial level, which adds further support for its broader implementation in other provinces. Future multi-center studies are needed to construct a comprehensive vaccine evaluation framework and make multi-criteria decisions on the feasibility of incorporating the Hib vaccine into China’s NIP. Full article
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11 pages, 585 KiB  
Article
Vaccination Status and Influencing Factors of Delayed Vaccination in Toddlers Born to Hepatitis B Surface Antigen-Positive Mothers
by Jinling Gao, Lin Luan, Yiheng Zhu, Jie Zhu, Zhiyuan Zhu, Tian Gong, Juan Xu and Na Liu
Vaccines 2025, 13(3), 286; https://doi.org/10.3390/vaccines13030286 - 7 Mar 2025
Viewed by 1263
Abstract
Background: This study aims to analyze the vaccination status and factors influencing delayed vaccination among toddlers born to hepatitis B surface antigen (HBsAg)-positive mothers. Methods: Data of HBsAg-positive mothers between 1 January 2021 and 31 December 2022 were provided by the [...] Read more.
Background: This study aims to analyze the vaccination status and factors influencing delayed vaccination among toddlers born to hepatitis B surface antigen (HBsAg)-positive mothers. Methods: Data of HBsAg-positive mothers between 1 January 2021 and 31 December 2022 were provided by the Suzhou Maternal and Child Health Care and Family Planning Service Center. The vaccination records were obtained from the Jiangsu Province Immunization Service Management Information System. Logistic regression analysis was used to analyze influencing factors of delayed vaccination. Results: A total of 4250 toddlers born to HBsAg-positive mothers were documented. The data revealed that the first dose of the hepatitis B vaccine was administered to 100% of the toddlers. In addition, the coverage of the National Immunization Program (NIP) vaccines among these toddlers ranged from 92.9% to 99.4%. The proportion of delayed NIP vaccination varied between 0% and 12.2%. The proportion of delayed Bacillus Calmette–Guérin (BCG) vaccination was 11.3%, with the delay predominantly observed between 4 and 6 months. Notably, the proportion of delayed BCG vaccination among the toddlers born to HBsAg-positive mothers was significantly higher than that in the general population. Additionally, the proportion of the first dose of non-NIP vaccines was 3.3–36.4%, and the proportion of DTaP-IPV/Hib was 27.0%. Logistic regression analysis revealed that the regional level, the mother’s human papillomavirus (HPV) vaccination status, and the infant’s birth weight were significant factors influencing the timeliness of vaccination. Conclusions: Although the vaccination status of toddlers born to HBsAg-positive mothers in Suzhou city remains stable, the issue of delayed vaccination requires attention. It is essential to continue strengthening targeted vaccine education to reduce vaccine hesitancy and improve the rate of timely vaccination. Full article
(This article belongs to the Special Issue Acceptance and Hesitancy in Vaccine Uptake: 2nd Edition)
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13 pages, 5542 KiB  
Article
Microstructure and Texture Evolution of High Permeability Grain-Oriented Silicon Steel
by Yujie Fu and Lifeng Fan
Metals 2025, 15(3), 268; https://doi.org/10.3390/met15030268 - 28 Feb 2025
Cited by 1 | Viewed by 625
Abstract
Industrialization trial production of high permeability (Hi-B) steel was carried out by “one cold rolled + decarburization and nitridation technologies”. The finished product reached the level of 23Q100 with an average grain size of 5.47 cm, magnetic flux density B8 of 1.902T, [...] Read more.
Industrialization trial production of high permeability (Hi-B) steel was carried out by “one cold rolled + decarburization and nitridation technologies”. The finished product reached the level of 23Q100 with an average grain size of 5.47 cm, magnetic flux density B8 of 1.902T, and the iron loss P1.7/50 of 0.975 W/Kg. The evolution law of the microstructure and texture under different processes was analyzed with the help of OM, EBSD, and XRD. The results showed that the microstructure of the hot rolled plate was equiaxed crystals in the surface layer, a mixture of recrystallization grains and banded fiber in the quarter of the thickness layer, and banded fiber in the center layer. The texture gradient of the hot rolled plate from the surface layer to the center layer was {112}<111> + {110}<114> → {441}<014> → {001}~{111}<110>. The texture of the normalized plate was in major {110}<113> in the surface layer, diffuse α-fiber texture and {441}<014> in the quarter of the thickness layer, and sharp α texture {001}~{111}<110> in the center layer. The texture of the cold-rolled sheet was concentrated in {001}~{332}<110>. The average grain size of the decarburizing and nitriding sheet was 26.4 μm, and the texture of the first recrystallization is sharp α*-fiber and weak {111}<112>. The finished product has a sharp single Goss texture. For Hi-B steel, the Goss secondary nucleus originated from the surface layer to 1/4 layer of the hot rolled plate and reached the highest content of 11.5% in the quarter of the thickness. The content of the Goss texture decreased with the subsequent normalization and cold rolling, then the Goss grains nucleated again during the decarburization annealing and high temperature annealing processes. Full article
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16 pages, 706 KiB  
Article
Racial Discrimination as a Traumatic Bedrock of Healthcare Avoidance: A Pathway Through Healthcare Institutional Betrayal and Mistrust
by Pedram Rastegar, L. Cai and Jennifer Langhinrichsen-Rohling
Healthcare 2025, 13(5), 486; https://doi.org/10.3390/healthcare13050486 - 24 Feb 2025
Cited by 1 | Viewed by 1217
Abstract
Objectives: Experiences of racial discrimination within the healthcare system are potentially traumatic events (PTEs) that have been associated with lowered perceived trust in healthcare providers, ongoing symptoms of PTSD and depression, and anticipated healthcare avoidance. Based on the BITTEN trauma impact model, we [...] Read more.
Objectives: Experiences of racial discrimination within the healthcare system are potentially traumatic events (PTEs) that have been associated with lowered perceived trust in healthcare providers, ongoing symptoms of PTSD and depression, and anticipated healthcare avoidance. Based on the BITTEN trauma impact model, we test a pathway such that greater past healthcare discrimination would be associated with anticipated future healthcare avoidance among BIPOC college students. We posited that this direct relationship would be sequentially mediated by healthcare institutional betrayal (HIB) during one’s worst healthcare event and subsequently reduced trust in healthcare. Methods: Our model was tested in a subsample of undergraduate students, all of whom self-identified with at least one minoritized racial or ethnic identity (n = 472). Participants reported on their past experiences with racial discrimination in healthcare. Each then chose and described their worst and/or most traumatic previous healthcare experience. Subsequently, they indicated if this experience included acts of HIB and/or led to medical mistrust. Finally, they reported on the degree to which they anticipated engaging in future healthcare avoidance. Results: Our model explained 31% of the variance in anticipated healthcare avoidance. As hypothesized via BITTEN, greater HIB during one’s worst or most traumatic healthcare experience and resulting mistrust in healthcare sequentially mediated the relationship between past experiences of healthcare racial discrimination and anticipated future healthcare avoidance. However, a direct relationship between racial discrimination in healthcare and anticipated healthcare avoidance was retained. Conclusions: Racial discrimination is a potentially traumatic experience associated with deleterious health outcomes. Current results suggest that healthcare discrimination may drive BIPOC college students’ future healthcare avoidance both directly and through experiencing increased healthcare institutional betrayal during one’s worst healthcare experience and resultant mistrust in healthcare. Due to the crucial role both discrimination and HIB experiences may play in healthcare outcomes, greater organizational adoption of anti-racist trauma-informed healthcare and the enactment of deliberate system-level repair strategies post discrimination and/or HIB is critical. Understanding the interplay of racial discrimination, HIB, and medical mistrust is also likely to help us address and repair system-level factors leading to anticipated healthcare avoidance behavior among BIPOC emerging adults. Full article
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15 pages, 977 KiB  
Article
The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study
by Ekaterina Alexeeva, Tatyana Dvoryakovskaya, Anna Fetisova, Ivan Kriulin, Elizaveta Krekhova, Anna Kabanova, Vladimir Labinov, Elizaveta Labinova and Mikhail Kostik
Vaccines 2025, 13(2), 177; https://doi.org/10.3390/vaccines13020177 - 12 Feb 2025
Cited by 1 | Viewed by 1194
Abstract
Background: Immunosuppressive therapy (methotrexate and biological agents) for juvenile idiopathic arthritis (JIA) is associated with an increased risk of severe infections, higher infection rates, treatment interruptions, failure to achieve disease remission, and recurrent disease flares. Our study aimed to evaluate the safety [...] Read more.
Background: Immunosuppressive therapy (methotrexate and biological agents) for juvenile idiopathic arthritis (JIA) is associated with an increased risk of severe infections, higher infection rates, treatment interruptions, failure to achieve disease remission, and recurrent disease flares. Our study aimed to evaluate the safety and efficacy of simultaneous immunization with 13-valent polysaccharide conjugate vaccines (PCV13) against S. pneumoniae (SP) and Hemophilus influanzae type b infections (HibV) in children with JIA without systemic manifestations. Methods: A total of 371 non-systemic JIA patients who received 13PCV and HibV were included in this prospective cohort study. In every patient, we evaluated clinical, laboratory, anti-SP, and anti-Hib IgG antibodies before vaccination, three weeks after, and six months after, and all adverse events (AEs) were collected during the study. The number and duration of acute respiratory infection (ARI) episodes and requirements for antibacterial treatment and AE six months before and after the baseline were collected. Results: The levels of the Ig G anti-SP and anti-Hib antibodies increased in the 3 weeks after vaccination; then, anti-SP antibodies slightly decreased and anti-Hib antibodies remained increased during the whole study, as well as in a part of the patients with a protective titer. During the study, there were no patients with significant flares, and the main JIA outcomes gradually decreased during the trial. The number of patients with uveitis remained equal, as well as the part of the patients with active, low-active, and inactive uveitis. There was no significant rise in the hs-CRP or S100 protein after the vaccination. Previous or ongoing treatment with non-biological (p = 0.072) and biological (p = 0.019) disease-modified anti-rheumatic drugs affected the Hib and did not affect the anti-SP protective titer at the end of the study. Within 6 months following vaccination, the number of ARI episodes (p < 0.001) and the number of courses of antibacterial treatment (p < 0.0001) decreased twice. The median duration of ARI episodes decreased four times (p < 0.0001). Mild AEs (injection site reactions and short-term fever episodes) were found in 58 (15.6%) patients with JIA, and 1 patient (0.2%) developed an SAE. Conclusions: Simultaneous vaccination against pneumococcal and Hib infections reduces the frequency and duration of episodes of ARI, as well as the number of courses of antibacterial drugs, and does not lead to significant JIA flares. The number of reported AEs is consistent with what was expected. Full article
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10 pages, 364 KiB  
Article
Vaccination Coverages Among Splenectomized Patients: A Retrospective Study from an Italian Southern Province
by Giuseppe Di Martino, Riccardo Mazzocca, Tania Masci, Lisa Berghella, Jacopo Del Papa, Francesco D’Aloisio, Mario Messinese, Fabrizio Cedrone, Patrizia Marani Toro and Graziella Soldato
Vaccines 2025, 13(2), 138; https://doi.org/10.3390/vaccines13020138 - 28 Jan 2025
Cited by 1 | Viewed by 1327
Abstract
Background: Splenectomized patients have a higher risk compared to the general population of developing post-splenectomy infection, particularly by capsulated bacteria. Splenectomized patients need to be vaccinated against pneumococcal diseases, meningococcal disease, and heamophilus influenzae (Hib) in order to avoid invasive bacterial diseases. This [...] Read more.
Background: Splenectomized patients have a higher risk compared to the general population of developing post-splenectomy infection, particularly by capsulated bacteria. Splenectomized patients need to be vaccinated against pneumococcal diseases, meningococcal disease, and heamophilus influenzae (Hib) in order to avoid invasive bacterial diseases. This study evaluated vaccination coverages among splenectomized patients in a Southern Italian province. Methods: A retrospective study was conducted evaluating all splenectomized patients from the Pescara province from 2015 to 2023. Vaccination coverages were calculated before and after splenectomy for the following vaccines: pneumococcal disease, meningococcal disease, Hib, and COVID-19. Results: A total of 97 patients were considered during the study period. Vaccination coverages were low before surgery, but they increased after splenectomy. Higher coverages were found against pneumococcal diseases (77.3%), meninigococcal disease (58.8%), and COVID-19 (91.8%). Conclusions: Vaccination coverages among splenectomized patients in the Pescara province are not satisfying. It is imperative to implement educational measures for patients and physicians to increase vaccination coverages. Full article
(This article belongs to the Special Issue Vaccination Strategies for Global Public Health)
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17 pages, 3198 KiB  
Article
Development and Evaluation of Five-in-One Vaccine Microneedle Array Patch for Diphtheria, Tetanus, Pertussis, Hepatitis B, and Haemophilus influenzae Type b: Immunological Efficacy and Long-Term Stability
by In-Jeong Choi, Hye-Ran Cha, Danbi Kwon, Aram Kang, Ji Seok Kim, Jooyoung Kim, Jeong-Eun Choi, Hyeon Woo Chung, Sunghoon Park, Doo Hee Shim, Tae-Hyun Kim, Seung-Ki Baek, Woon-Sung Na, Jae Myun Lee and Jung-Hwan Park
Pharmaceutics 2024, 16(12), 1631; https://doi.org/10.3390/pharmaceutics16121631 - 23 Dec 2024
Cited by 1 | Viewed by 2219
Abstract
Background and objectives: The development of a five-in-one vaccine microneedle patch (five-in-one MN patch) aims to address challenges in administering vaccines against Diphtheria (DT), Tetanus (TT), Pertussis (wP), Hepatitis B (HBsAg), and Haemophilus influenzae type b (Hib). Combining multiple vaccines into a [...] Read more.
Background and objectives: The development of a five-in-one vaccine microneedle patch (five-in-one MN patch) aims to address challenges in administering vaccines against Diphtheria (DT), Tetanus (TT), Pertussis (wP), Hepatitis B (HBsAg), and Haemophilus influenzae type b (Hib). Combining multiple vaccines into a single patch offers a novel solution to improve vaccine accessibility, stability, and delivery efficiency, particularly in resource-limited settings. Methods: The five-in-one MN patch consists of four distinct microneedle arrays: DT and TT vaccines are coated together on one array, while wP, HepB, and Hib vaccines are coated separately on individual arrays. The patch was tested for long-term stability (12 months at 25 °C) and evaluated for immunogenicity in mice and minipigs. Antibody titers were measured using ELISA to compare immune responses between microneedle-based delivery and traditional intramuscular (IM) injection. Results: The five-in-one MN patch demonstrated stable antigenicity for up to 12 months at room temperature. In animal studies, the patch induced antibody titers comparable to traditional IM injections for all vaccines. Notably, immunogenic responses to Pertussis and Haemophilus influenzae type b vaccines via microneedles were reported for the first time. The patch facilitated the simultaneous yet independent delivery of vaccines, preserving their immunogenicity without interference. Conclusions: The five-in-one MN patch represents a significant advancement in vaccine delivery by enabling stable, minimally invasive, and efficient immunization. Its innovative design addresses the critical limitations of combination vaccines and has the potential to enhance vaccine accessibility in low- and middle-income countries. Future studies will focus on optimizing patch application techniques and evaluating broader clinical applicability. Full article
(This article belongs to the Special Issue Microarray Patches for Transdermal Drug Delivery)
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18 pages, 3148 KiB  
Article
Evaluating the Compatibility of Three Aluminum Salt-Adjuvanted Recombinant Protein Antigens (Trivalent NRRV) Combined with a Mock Trivalent Sabin-IPV Vaccine: Analytical and Formulation Challenges
by Prashant Kumar, Atsushi Hamana, Christopher Bird, Brandy Dotson, Soraia Saleh-Birdjandi, David B. Volkin and Sangeeta B. Joshi
Vaccines 2024, 12(10), 1102; https://doi.org/10.3390/vaccines12101102 - 26 Sep 2024
Cited by 1 | Viewed by 1747
Abstract
In this work, we describe compatibility assessments of a recombinant, trivalent non-replicating rotavirus vaccine (t-NRRV) candidate with a mock trivalent Sabin inactivated polio vaccine (t-sIPV). Both t-sIPV and t-NRRV are incompatible with thimerosal (TH), a preservative commonly used in pediatric pentavalent combination vaccines [...] Read more.
In this work, we describe compatibility assessments of a recombinant, trivalent non-replicating rotavirus vaccine (t-NRRV) candidate with a mock trivalent Sabin inactivated polio vaccine (t-sIPV). Both t-sIPV and t-NRRV are incompatible with thimerosal (TH), a preservative commonly used in pediatric pentavalent combination vaccines (DTwP-Hib-HepB) distributed in low- and middle-income countries (LMICs), preventing the development of a heptavalent combination. The compatibility of t-NRRV with a mock DTwP-Hib-HepB formulation is described in a companion paper. This case study highlights the analytical and formulation challenges encountered when combining a mock t-sIPV vaccine (unadjuvanted) with Alhydrogel® (AH) adjuvanted t-NRRV. Selective and stability-indicating competition ELISAs were implemented to monitor antibody binding to each of the six antigens (±AH). Simple mixing caused the undesired desorption of t-NRRV from AH with the concomitant binding of t-sIPV to AH. Although the former effect was mitigated by dialyzing sIPV bulks, decreased sIPV storage stability was observed at accelerated temperatures in the bivalent combination with a rank-ordering of P[8] > P[6] > P[4] and sIPV3 > sIPV2 > sIPV1. The compatibility of AH-adsorbed t-sIPV with alternative preservatives was evaluated, and parabens (methyl, propyl) were identified for potential use in this multi-dose bivalent formulation. Along with a companion paper, the lessons learned are discussed to facilitate the future formulation development of pediatric combination vaccines with new antigens. Full article
(This article belongs to the Special Issue Recent Advances in Vaccine Adjuvants and Formulation)
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12 pages, 235 KiB  
Article
Correlates of Zero-Dose Status among Children Aged 12–23 Months in the Luambo Health District, Democratic Republic of Congo: A Matched Case–Control Study
by Esperent Ntambue Malu, Alain Nzanzu Magazani, Jean Bosco Kasonga, Adèle Mudipanu, Michel Kabamba Nzaji, Daniel Katuashi Ishoso and Dalau Mukadi Nkamba
Vaccines 2024, 12(7), 700; https://doi.org/10.3390/vaccines12070700 - 21 Jun 2024
Viewed by 1817
Abstract
(1) Background: “Zero-dose” (ZD) refers to a child who has not received any doses of the pentavalent (diphtheria–tetanus–pertussis–Haemophilus influenzae type b (Hib)–hepatitis B) vaccine. ZD children are vulnerable to vaccine-preventable diseases (VPDs). Luambo health district (HD) is one of 26 HDs in [...] Read more.
(1) Background: “Zero-dose” (ZD) refers to a child who has not received any doses of the pentavalent (diphtheria–tetanus–pertussis–Haemophilus influenzae type b (Hib)–hepatitis B) vaccine. ZD children are vulnerable to vaccine-preventable diseases (VPDs). Luambo health district (HD) is one of 26 HDs in Kasai Central Province in Democratic Republic of the Congo and had the largest number of ZD children in 2021. This study was conducted to identify factors associated with ZD status among children in Luambo HD. (2) Methods: We conducted a mixed-methods study of children aged 12–23 months in Luambo HD. (3) Results: A total of 445 children aged 12–23 months were included in the study, including 89 cases and 356 controls. Children who were born in Angola (AOR = 3.2; 95% CI = 1.1 to 9.8; p = 0.046), born at home (AOR = 5.2; 95% CI = 2.1 to 12.5; p < 0.001), whose mothers did not receive antenatal care (AOR = 4.4; 95% CI = 1.2 to 16.3; p = 0.023), or did not know any vaccine preventable disease (AOR = 13.3; 95% CI = 4.6 to 38.4; p < 0.001) were more likely to be ZD than their counterparts. In addition, perceptions of children’s parents influenced child immunization. (4) Conclusions: Factors associated with being a ZD child suggest inequalities in vaccination that need to be addressed through appropriate interventions. Maternal and child health services need to be strengthened while also targeting children’s fathers. This will make it possible to considerably reduce the proportion of ZD and undervaccinated children and effectively fight against VPDs. Full article
25 pages, 4692 KiB  
Article
Evaluating the Compatibility of New Recombinant Protein Antigens (Trivalent NRRV) with a Mock Pentavalent Combination Vaccine Containing Whole-Cell Pertussis: Analytical and Formulation Challenges
by Prashant Kumar, David A. Holland, Kathryn Secrist, Poorva Taskar, Brandy Dotson, Soraia Saleh-Birdjandi, Yetunde Adewunmi, Jennifer Doering, Nicholas J. Mantis, David B. Volkin and Sangeeta B. Joshi
Vaccines 2024, 12(6), 609; https://doi.org/10.3390/vaccines12060609 - 3 Jun 2024
Cited by 2 | Viewed by 2807
Abstract
Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated [...] Read more.
Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated with Alhydrogel® adjuvant, AH) combined with a mock multidose formulation of a pediatric pentavalent vaccine used in LMICs. This complex formulation contained (1) vaccine antigens (i.e., whole-cell pertussis (wP), diphtheria (D), tetanus (T), Haemophilus influenza (Hib), and hepatitis B (HepB), (2) a mixture of aluminum-salt adjuvants (AH and Adju-Phos®, AP), and (3) a preservative (thimerosal, TH). Selective, stability-indicating competitive immunoassays were developed to monitor binding of specific mAbs to each antigen, except wP which required the setup of a mouse immunogenicity assay. Simple mixing led to the desorption of t-NRRV antigens from AH and increased degradation during storage. These deleterious effects were caused by specific antigens, AP, and TH. An AH-only pentavalent formulation mitigated t-NRRV antigen desorption; however, the Hib antigen displayed previously reported AH-induced instability. The same rank-ordering of t-NRRV antigen stability (P[8] > P[4] > P[6]) was observed in mock pentavalent formulations and with various preservatives. The lessons learned are discussed to enable future multidose, combination vaccine formulation development with new vaccine candidates. Full article
(This article belongs to the Special Issue Recent Advances in Vaccine Adjuvants and Formulation)
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16 pages, 765 KiB  
Article
Understanding College Students’ Healthcare Avoidance: From Early Maladaptive Schemas, through Healthcare Institutional Betrayal and Betrayal Trauma Appraisal of Worst Healthcare Experiences
by Pedram J. Rastegar and Jennifer Langhinrichsen-Rohling
Healthcare 2024, 12(11), 1126; https://doi.org/10.3390/healthcare12111126 - 31 May 2024
Cited by 2 | Viewed by 1349
Abstract
Understanding healthcare avoidance among college students is critical. In this study, we consider two broad cognitive contributors to greater healthcare avoidance: specific early maladaptive schema and negative appraisals of students’ prior worst healthcare experiences. From schema theory, we proposed college students holding greater [...] Read more.
Understanding healthcare avoidance among college students is critical. In this study, we consider two broad cognitive contributors to greater healthcare avoidance: specific early maladaptive schema and negative appraisals of students’ prior worst healthcare experiences. From schema theory, we proposed college students holding greater levels of two early maladaptive schema (disconnection/rejection and impaired autonomy/performance EMS) would be more likely to appraise their problematic healthcare experience as both containing healthcare institutional betrayal (HIB) behaviors and as traumatic and betrayal-inducing; both EMS and these appraisals would predict healthcare avoidance. Using a cross-sectional survey in a large, diverse college student sample (n = 1383, 61.1% female, 18.9% African American, 7.2% Asian, 6.4% Hispanic/Latino), as predicted, both EMS were significantly related to healthcare avoidance. Furthermore, a sequential mediation model was supported, indicating students holding greater EMS of disconnection/rejection or impaired autonomy/rejection reported more HIB in their worst healthcare experience, and appraised that experience as more betraying. Taken altogether, this model accounted for 23% of the variance in students’ reports of healthcare avoidance. Core beliefs formed early in life may be a foundational lens through which potentially traumatic healthcare experiences are processed in ways that can impact emerging adults’ future healthcare engagement. Findings also support the importance of addressing HIB actions and repairing trauma appraisals accrued during problematic healthcare experiences to prevent healthcare avoidance by emerging adults. Full article
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9 pages, 773 KiB  
Article
Hot Iron Branding of Beef Cattle: Process Characterization, Implications for Animal Welfare, and Its Efficiency for Cattle Individual Identification
by Jaira de Oliveira, Joseph Kaled Grajales-Cedeño, Mariana Parra Cerezo, Tiago S. Valente and Mateus J. R. Paranhos da Costa
Ruminants 2024, 4(2), 192-200; https://doi.org/10.3390/ruminants4020013 - 9 Apr 2024
Cited by 1 | Viewed by 3057
Abstract
This study aimed to characterize the hot iron branding (HIB) procedure by assessing its implications for animal welfare and its efficiency for cattle identification. The study was carried out in two stages: First, with 37 Nellore calves, by measuring the skin temperatures in [...] Read more.
This study aimed to characterize the hot iron branding (HIB) procedure by assessing its implications for animal welfare and its efficiency for cattle identification. The study was carried out in two stages: First, with 37 Nellore calves, by measuring the skin temperatures in the place of HIB application (ONB) and 10 cm above it (OFFB) immediately after its application and during four consecutive days, the time required for application of each HIB digit and the occurrences of rebranding; second, with two batches of cows (N = 97 and N = 94, respectively, by measuring the time spent to read cattle ID and comparing the efficiency of HIB vs. EET (electronic ear tag) and visual ear tags (VET) vs. EET. Skin temperature was significantly affected by the interaction between the place where the skin temperatures were taken (on and 10 cm above the HIB) and assessment day, with temperatures in ONB on days d0 and d2 being higher than in OFFB (p < 0.05), and 86% of the calves required at least one rebranding. EET reading was faster than HIB and VET (p < 0.001), and fewer errors were made when reading EET than HIB (1/97 vs. 17/97) and VET (2/94 vs. 12/94). We concluded that HIB potentially compromises cattle welfare and has a lower efficiency for cattle identification than EET and VET. Full article
(This article belongs to the Special Issue Beef Cattle Production and Management)
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