VaccinePub Date : 2025-04-08DOI: 10.1016/j.vaccine.2025.127047
Monika Zasztowt-Sternicka , Anna Jagielska , Michał Rząd , Iwona Szymusik , Ewelina Hallmann , Lidia Brydak , Aneta Nitsch-Osuch
{"title":"Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood","authors":"Monika Zasztowt-Sternicka , Anna Jagielska , Michał Rząd , Iwona Szymusik , Ewelina Hallmann , Lidia Brydak , Aneta Nitsch-Osuch","doi":"10.1016/j.vaccine.2025.127047","DOIUrl":"10.1016/j.vaccine.2025.127047","url":null,"abstract":"<div><h3>Background</h3><div>Infants and pregnant women are particularly vulnerable to severe illness and complications of influenza. It is necessary to increase knowledge about the safety and effectiveness of influenza vaccination during pregnancy to improve awareness among patients and healthcare professionals and increase to increase vaccination coverage.</div></div><div><h3>Methods</h3><div>A prospective, single-group clinical study was performed in the 2021/2022 and 2022/2023 seasons. The aim of the study was to assess the immunogenicity and tolerance of quadrivalent influenza vaccine (IIV4) in pregnant women, to evaluate transplacental antibody (AB) transfer after IIV4 administration, and to estimate optimal gestational age for vaccination. A group of 62 pregnant women between 14 and 37 weeks of gestation, including 59 mother-child pairs, underwent vaccination with IIV4. The humoral immune response was assessed using the EMA criteria.</div></div><div><h3>Results</h3><div>Baseline seroprotection for all IIV4 strains was significantly correlated with previous vaccinations (<em>p</em> < .5). The postvaccination seroprotection ranged between 71 % and 94 %. A significant increase in AB titers was observed for all vaccine strains (<em>p</em> < .0000). No significant differences were observed in seroprotection and seroconversion rates or transplacental AB transfer between women vaccinated in the 2nd vs 3rd trimester of pregnancy. All IIV4 strains used in the study met at least 1 of the 3 EMA/CPMP immunogenicity criteria and may thus be considered immunogenic. Seroprotection for A/H1N1/pdm09, A/H3N2, B/lineage Victoria (B/V), and B/lineage Yamagata (B/Y) antigens was achieved by 97 %, 95 %, 59 %, and 85 % of neonates, respectively. Over 43 % of participants reported solicited injection site reactions. None of the participants reported severe or unsolicited adverse events.</div></div><div><h3>Conclusions</h3><div>IIV4 induced a strong immune response in pregnant women and a high rate of seroprotection in neonates. Immune protection in children did not differ according to the trimester of vaccination in pregnancy. IIV4 was well tolerated by pregnant women.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127047"},"PeriodicalIF":4.5,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143790832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-08DOI: 10.1016/j.vaccine.2025.127069
Patricia C. Lloyd , Gyanada Acharya , Henu Zhao , Nimesh Shah , Godwin Anguzu , Derick Ambarsoomzadeh , Tainya C. Clarke , Xinyi Ng , Mao Hu , Yoganand Chillarige , Richard A. Forshee , Steven A. Anderson
{"title":"Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Medicare beneficiaries aged 65 years and older","authors":"Patricia C. Lloyd , Gyanada Acharya , Henu Zhao , Nimesh Shah , Godwin Anguzu , Derick Ambarsoomzadeh , Tainya C. Clarke , Xinyi Ng , Mao Hu , Yoganand Chillarige , Richard A. Forshee , Steven A. Anderson","doi":"10.1016/j.vaccine.2025.127069","DOIUrl":"10.1016/j.vaccine.2025.127069","url":null,"abstract":"<div><h3>Background</h3><div>Influenza vaccination is widely recommended for individuals aged 6 months and older in the United States. While the safety of annual influenza vaccines is well established, FDA conducts routine monitoring and safety evaluations. This study assessed the safety of 2023–2024 influenza vaccines among elderly Medicare beneficiaries.</div></div><div><h3>Methods</h3><div>A self-controlled case series (SCCS) analysis compared incidence rate ratios (IRR) of anaphylaxis, encephalitis/encephalomyelitis/acute disseminated encephalomyelitis, Guillain-Barré syndrome (GBS), transverse myelitis, hemorrhagic stroke, non-hemorrhagic stroke, transient ischemic attack (TIA), and non-hemorrhagic stroke/TIA, following 2023–2024 seasonal influenza vaccinations in risk and control intervals among Medicare beneficiaries aged 65 years and older. We used conditional Poisson regression to estimate IRRs and 95 % confidence intervals (CIs) adjusted for event-dependent observation time for certain outcomes, seasonality, and uncertainty from outcome misclassification where feasible. For health outcomes with statistically significant associations, we stratified results by concomitant vaccination status.</div></div><div><h3>Results</h3><div>We observed 20,258,006 influenza vaccinees, and no statistically significant elevations of risk for anaphylaxis, encephalitis/encephalomyelitis (with ADEM), GBS, hemorrhagic stroke, or transverse myelitis. For the combined non-hemorrhagic stroke/TIA outcome (22–42-day risk window), we observed a small elevation in risk that was statistically significant in both the Fee-for-Service (IRR: 1.07; 95 % CI: 1.01, 1.14) and Medicare Advantage (IRR: 1.10; 95 % CI: 1.02, 1.17) populations that received a high-dose vaccine. This was also observed among Medicare Advantage beneficiaries that received any influenza vaccine (IRR: 1.11; 95 % CI: 1.01, 1.22). Additionally, we observed a small statistically significant risk for the individual TIA outcome (22–42-day risk window) among the Medicare Advantage population that received any influenza vaccine.</div></div><div><h3>Conclusion</h3><div>The benefits of seasonal influenza vaccines established by past studies likely outweigh the risks found in this study. The small, elevated risk of stroke outcomes must be carefully considered in light of the known benefits of influenza vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127069"},"PeriodicalIF":4.5,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143790890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-07DOI: 10.1016/j.vaccine.2025.127102
Ander Diez , Ines Arrieta-Aguirre , Giulia Carrano , Marta Bregón-Villahoz , Maria-Dolores Moragues , Iñigo Fernandez-de-Larrinoa
{"title":"A synthetic peptide vaccine induces protective immune responses against Candida albicans infection in immunocompromised mice","authors":"Ander Diez , Ines Arrieta-Aguirre , Giulia Carrano , Marta Bregón-Villahoz , Maria-Dolores Moragues , Iñigo Fernandez-de-Larrinoa","doi":"10.1016/j.vaccine.2025.127102","DOIUrl":"10.1016/j.vaccine.2025.127102","url":null,"abstract":"<div><div>Invasive fungal infections, such as those caused by <em>Candida</em> species, predominantly affects hospitalized and immunocompromised patients. Current mortality rates are expected to rise as drug-resistant fungal species increase and the pool of immunocompromised individuals grows. Today, antifungal treatments show limited effectiveness, underscoring the need for new safe and effective antifungal vaccines. This study investigates the efficacy of a protective immunization strategy with DC stimulated by a synthetic peptide, 3P-KLH, containing epitopes from three <em>Candida albicans</em> proteins (Als3, Hwp1 and Met6) against a model of invasive candidiasis raised in immunosuppressed mice. Immunization effectively stimulated both humoral and cellular immune responses, as indicated by high antibody titers to the synthetic fungal peptide, increased cytokine levels, reduced fungal burden in kidneys and improved survival outcomes following infection.</div><div>Although the variability in fungal burden in the control group limited the statistical significance for fungal clearance data, immunized mice showed a 64-fold lower fungal burden in renal tissues compared to controls. Cytokine analysis revealed elevated levels of IL-2, IL-17, and IFN-γ, suggesting a strong activation of Th1 and Th17 responses, both essential for antifungal immunity.</div><div>Survival data further supported the protective effect of the immunogenic agent: 62.5 % immunized mice survived the 21-day post-infection period compared to 100 % mortality in controls. The progressively lower fungal burden over time in surviving mice suggests a sustained immune response that continues to suppress fungal replication. These results suggest that the immunization with the synthetic peptide stimulates a strong immune response, involving both antibody production and cell-mediated immunity, making it a promising candidate for therapeutic strategies against invasive candidiasis. Future work should focus on optimizing this immunization approach, assessing long-term immunity, and evaluating its potential in other fungal infection models.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127102"},"PeriodicalIF":4.5,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-07DOI: 10.1016/j.vaccine.2025.127061
Sean Prall , Aparicio Lopes
{"title":"“Better to die trying”: Vaccine perceptions and COVID-19 experiences in rural Namibian pastoralists","authors":"Sean Prall , Aparicio Lopes","doi":"10.1016/j.vaccine.2025.127061","DOIUrl":"10.1016/j.vaccine.2025.127061","url":null,"abstract":"<div><div>Substantial research indicates that local explanatory models of disease shape heath behaviors. However, less is known regarding how cultural models of disease influence interpretations of vaccines. Vaccination decisions are based around a plethora of social and cultural factors, including beliefs about disease, cultural-historical experiences with healthcare, and recent vaccination experiences. To understand how local interpretations of vaccination influence vaccination-decision making, we explore cultural models of health, vaccine norms, and COVID-19 beliefs and experiences in Himba and Herero pastoralists of the Kunene region of northern Namibia. Mixed sex focus groups were conducted in July and August of 2024 in communities across a rural and peri-urban gradient. Discussion prompts were designed to elicit dialogue on vaccination beliefs, norms, and experiences, as well as their recent experience with COVID-19. Results from these focus groups indicate that there was substantial confusion differentiating vaccinations from other types of injections. For childhood vaccines, immunization is normative and expected. Women were the primary decision-makers for childhood immunization, reflecting the matrilineal bias of Himba and Herero kinship. For adults, while local leaders had some influence interfacing with public health outreach, the decision to get vaccinated was largely a personal one. Beliefs about COVID-19 were interpreted through pre-existing cultural models of illness, and beliefs about the origins of COVID-19 reflected mistrust in international actors. Fears about COVID-19 vaccines were common, particularly concerns about vaccine safety. However, fears of the illness typically overrode fears of the vaccine, and most report receiving the vaccine despite these worries. These results highlight the importance of extending research beyond a knowledge, attitude, practice framework to incorporate local explanatory models and cultural-historical experiences in understanding vaccine-decision making. These features are particularly important in more traditional, rural, and marginalized populations where medical mistrust is common and local explanatory models of disease drive healthcare decision-making.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"55 ","pages":"Article 127061"},"PeriodicalIF":4.5,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-07DOI: 10.1016/j.vaccine.2025.127072
A. Mollo , M. Peri , L. Lodi , A. Gissi , P. Lionetti , E. Marrani , M.V. Mastrolia , A. Tondo , V. Tintori , I. Sardi , G. Indolfi , S. Trapani , L. Galli , E. Venturini , V. Astorino , C. Azzari , S. Ricci
{"title":"Considering recombinant herpes zoster vaccine for fragile pediatric patients: A new opportunity","authors":"A. Mollo , M. Peri , L. Lodi , A. Gissi , P. Lionetti , E. Marrani , M.V. Mastrolia , A. Tondo , V. Tintori , I. Sardi , G. Indolfi , S. Trapani , L. Galli , E. Venturini , V. Astorino , C. Azzari , S. Ricci","doi":"10.1016/j.vaccine.2025.127072","DOIUrl":"10.1016/j.vaccine.2025.127072","url":null,"abstract":"<div><h3>Background</h3><div>A recombinant vaccine is approved to prevent herpes zoster (HZ) in adults ≥50 years and immunocompromised individuals ≥19 years. However, in children, the live attenuated vaccine remains the only prevention strategy against varicella zoster virus (VZV), with only one trial evaluating the safety and immunogenicity of GlaxoSmithKline's HZ subunit candidate vaccine in immunocompromised children.</div></div><div><h3>Objectives</h3><div>To estimate VZV burden in our third level pediatric hospital and identify high-risk pediatric groups for its occurrence and complications to explore the need for an inactivated vaccine.</div></div><div><h3>Methods</h3><div>We reviewed VZV/HZ hospital discharge codes and positive VZV molecular tests at Meyer Children's Hospital from January 2018 to May 2023. We categorized patients based on their vaccination status as unvaccinated, partially vaccinated (single dose), or fully vaccinated (complete two-dose regimen). 96 controls from the same Departments and period were also included to assess VZV vaccine effectiveness.</div></div><div><h3>Results</h3><div>Of 48 patients with VZV (52 % female; median age: 11.6 years [IQR: 7–14.2]), 10 had chickenpox and 38 HZ; 2/48 (4.2 %) received 2 doses of vaccination, 10/48 (20.8 %) were immunized with 1 dose and 36/48 (75 %) were unvaccinated. Immune-related comorbidities were present in 20/48 (42 %) patients, and among those with HZ requiring hospitalization, comorbidities strongly predicted admission (OR 4.71; 95 % CI, 1.23–20.39; <em>p</em> = 0.028). Full vaccination was more frequent in controls (43/96, 45 %) than in cases (2/48, 4.2 %; <em>p</em> < 0.001).</div></div><div><h3>Conclusions</h3><div>In our cohort, many cases had comorbidities contraindicating the live attenuated vaccine. If proven safe and effective, the recombinant HZ vaccine could offer a preventive option for immunocompromised children ineligible for live viral vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127072"},"PeriodicalIF":4.5,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-06DOI: 10.1016/j.vaccine.2025.127071
Christina Shearn , Gianina-Ioana Postavaru , Lorna Hylton , Howard Morris , Noelle Robertson , Eva M. Krockow
{"title":"COVID-19 vaccine decision-making and the role of institutions across the pandemic in UK Black African and Black Caribbean communities","authors":"Christina Shearn , Gianina-Ioana Postavaru , Lorna Hylton , Howard Morris , Noelle Robertson , Eva M. Krockow","doi":"10.1016/j.vaccine.2025.127071","DOIUrl":"10.1016/j.vaccine.2025.127071","url":null,"abstract":"<div><h3>Introduction</h3><div>In the UK, individuals from Black African and Black Caribbean backgrounds show particularly low rates of COVID-19 vaccination uptake. Initial research highlighted institutional mistrust as a prevalent influencing factor in COVID-19 vaccine decision-making, but most data were obtained from un-differentiated minority ethnic samples. This study explored the role of institutional mistrust across the entire COVID-19 vaccination rollout period, focusing on Black African and Black Caribbean communities.</div></div><div><h3>Methods</h3><div>Purposive sampling resulted in 13 participants (7 = male, 6 = female; <em>M</em> = 52 years), who expressed uncertainty about one or more of the menu of COVID-19 vaccinations. An in-person focus group and online semi-structured interviews were conducted to explore COVID-19 vaccination views and institutional influences. Data were analysed thematically.</div></div><div><h3>Results</h3><div>Three overarching themes were identified, each with constituent sub-themes, mapping onto the chronological sequence of the vaccination rollout: (1) ‘mistrust during initial vaccine decision-making’ (e.g., highlighting historical racial inequities and biased news exposure), (2) ‘negative experiences of institutions during the pandemic’ (e.g., highlighting systemic pressures to vaccination and perceptions of deception), and (3) ‘vaccination attitudes post-pandemic’ (e.g., highlighting varied views and concerns about booster vaccinations).</div></div><div><h3>Conclusions</h3><div>Findings emphasize the enduring influence of institutions on COVID-19 vaccination attitudes of UK individuals from Black African and Black Caribbean backgrounds. Initial vaccination adherence through perceived coercive governmental strategies appeared counterproductive for ongoing willingness to vaccinate. Instead, co-producing campaigns and providing opportunities to discuss concerns with trusted healthcare professionals in the community are recommended. These findings can be applied to future vaccination campaigns against COVID-19 and other similar health threats.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127071"},"PeriodicalIF":4.5,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143783728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-05DOI: 10.1016/j.vaccine.2025.127064
Natasha Davidson, Jane Fisher
{"title":"“If I know about it of course I would give my son and daughter”, barriers to and enablers of accessing human papillomavirus vaccination among women from refugee and asylum-seeking backgrounds resettling in Melbourne, Australia – A qualitative study","authors":"Natasha Davidson, Jane Fisher","doi":"10.1016/j.vaccine.2025.127064","DOIUrl":"10.1016/j.vaccine.2025.127064","url":null,"abstract":"<div><h3>Background</h3><div>Women from refugee and asylum-seeking backgrounds have lower human papillomavirus vaccination (HPVV) rates than host country populations. Improving HPVV rates is important in the prevention of cervical cancer. This qualitative study gained an in-depth understanding of refugee and asylum-seeking women's barriers to and enablers of accessing HPVV services and information for their children post-resettlement in Melbourne, Australia.</div></div><div><h3>Methods</h3><div>A qualitative study using semi-structured interviews was conducted with a purposive sample of women from Myanmar, Iraq, Syria and women seeking asylum from different countries. A bi-cultural worker assisted in recruitment and interpreting during data collection. Between December 2021 and September 2023 interviews were conducted in the participants first language with a bi-cultural worker or volunteer interpreting into English during the interview. Audio recordings of English dialogue were transcribed verbatim. Reflexive thematic analysis was used to analyse and report data.</div></div><div><h3>Results</h3><div>Thirty-one refugees and 12 women seeking asylum from eleven countries were interviewed. Barriers to and enablers of HPVV were identified. 1) Barriers to awareness and knowledge of HPVV included: limited awareness of HPVV, lack of access to HPV vaccine information in the pre-arrival context, uncertainty about HPV vaccine safety and effectiveness, gender association with HPVV, negative influence of COVID vaccination on HPV vaccine perceptions. Enablers included: Understanding future benefits: prevention is better than cure 2) Barriers to sociocultural influences included: necessity for HPVV at recommended age, Enablers included: promoting peer support 3) Barriers to health information seeking included: missed opportunities for information delivery at schools and language classes, inconsistent messaging. Enablers included: trust in the education programs, health care provider recommendation, desire for new knowledge.</div></div><div><h3>Conclusion</h3><div>Improving HPVV access requires a multi-faceted approach to enhance women's awareness and knowledge. Key strategies include providing routine HPVV education through resettlement services and school programs, supporting healthcare providers in educating women unfamiliar with HPVV, and delivering clear messaging about the recommended age and addressing gender-related misconceptions.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-05DOI: 10.1016/j.vaccine.2025.127082
Guifan Li , Shouchun Cao , Bidan Xu , Jialei Hu , Lei Zhang , Leitai Shi , Danhua Zhao , Yixin Li , Yafei Liu , Qi Liang , Xiaohong Wu
{"title":"Safety, immunogenicity and immune persistence of a lyophilized purified human diploid cells rabies vaccine following rabies PEP regimen Essen and Zagreb: A randomized, blinded controlled phase 3 trial in healthy participants aged 10–60 years old","authors":"Guifan Li , Shouchun Cao , Bidan Xu , Jialei Hu , Lei Zhang , Leitai Shi , Danhua Zhao , Yixin Li , Yafei Liu , Qi Liang , Xiaohong Wu","doi":"10.1016/j.vaccine.2025.127082","DOIUrl":"10.1016/j.vaccine.2025.127082","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the safety, immunogenicity and immune persistence of a lyophilized purified human diploid cells rabies vaccine in healthy and previously unvaccinated people in a simulated rabies post-exposure prophylaxis, by traditional 5-dose Essen regimen and abbreviated 4-dose Zagreb regimen.</div></div><div><h3>Methods</h3><div>A cohort of 1800 healthy participants aged 10–60 years old were randomized into three groups: 5-dose test group (T5, Essen regimen), 5-dose control group (C5, Essen regimen) and 4-dose test group (T4, Zagreb regimen) according to the ratio of 1:1:1, and inoculated with trial vaccine or control vaccine separately to analyze the safety of vaccine as well as rabies antibody levels before and after vaccination.</div></div><div><h3>Results</h3><div>Adverse reactions (AEs) mainly occurred after the initial dose of immunization, which were mostly mild (grade 1) in severity. The incidence of total AEs in T4 (38 %) was lower than that in C5 (45 %) (<em>P</em> = 0.02) from the initial dose to 28 days after the final dose; fever rate in T5 (12 %, <em>P</em> = 0.01) and T4 (13 %, <em>P</em> = 0.03) was lower than that in C5 (17 %). No vaccine-related serious AEs (SAEs) were observed. Seroconversion rates reached 100 % in all three groups 14 days following the first dose. Moreover, the seroconversion rate was 98 %, 96 % and 98 % 12 months following the first dose in T5, C5 and T4, respectively. Both T5 and T4 displayed higher neutralizing antibodies geometric mean concentration (GMC) and geometric mean increase (GMI) compared to those in C5 on day 7, day 14, and 12 months after the first dose, as well as on day 14 after the last dose. There were no significant differences in the incidence of AEs, seroconversion rate, GMC and GMI between T5 and T4.</div></div><div><h3>Conclusion</h3><div>The trial vaccine administered following both Essen regimen and Zagreb regimen shows good safety, immunogenicity and immune persistence, and the trial vaccine is not inferior to the control vaccine.</div><div><strong>Clinical Trials Registration:</strong> <span><span>NCT03971370</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127082"},"PeriodicalIF":4.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-05DOI: 10.1016/j.vaccine.2025.127076
Elisa Ferreras-Colino , José de la Fuente , Joana Couto , Maryna Golovchenko , Sandra Antunes , Iker A. Sevilla , Ana Domingos , Natalie Rudenko , Marinela Contreras , Rafael Martínez-Camacho , Christian Gortazar , María A. Risalde
{"title":"Immunostimulant effect of heat-inactivated Mycobacterium bovis in mice challenged with vector-borne pathogens","authors":"Elisa Ferreras-Colino , José de la Fuente , Joana Couto , Maryna Golovchenko , Sandra Antunes , Iker A. Sevilla , Ana Domingos , Natalie Rudenko , Marinela Contreras , Rafael Martínez-Camacho , Christian Gortazar , María A. Risalde","doi":"10.1016/j.vaccine.2025.127076","DOIUrl":"10.1016/j.vaccine.2025.127076","url":null,"abstract":"<div><div>Trained immunity is defined as an enhanced state of the innate system which leads to an improved immune response against related or non-related pathogens. Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated <em>Mycobacterium bovis</em> strain, is currently one of the main inductors of trained immunity. The objective of the present study was to evaluate the protective effects of heat-inactivated <em>M. bovis</em> (HIMB) against <em>Plasmodium berghei</em> and <em>Borrelia burgdorferi</em> and characterize the immunological mechanisms involved. BALB/c and C3H/HeN mice were randomly assigned in similar number to either immunized group receiving two oral doses of HIMB with a 4-week interval, or control group treated with PBS. All the BALB/c mice were intraperitoneally infected with <em>P. berghei</em> while the C3H/HeN mice were subcutaneously infected with <em>B. burgdorferi</em>. Pathogen burden was significantly reduced in both immunized groups when compared to controls. The number of macrophages significantly decreased in the liver or in the spleen of the mice that had been immunized prior to the challenge with <em>P. berghei</em> or <em>B. burgdorferi</em>, respectively. Furthermore, the immunized groups showed an apparent upregulation of IFN-γ, TNF-α and IL-1α in the liver (<em>P. berghei</em> challenge) or a significant increase in IL-1α producing cells in the spleen (<em>B. burgdorferi</em> challenge). Our findings suggest that oral immunization with heat-inactivated mycobacteria limits pathogen burden through stimulation of the innate immune response in two vector-borne diseases in mice.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127076"},"PeriodicalIF":4.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
VaccinePub Date : 2025-04-05DOI: 10.1016/j.vaccine.2025.127084
Kimberly A. Fisher , Lydia Goldthwait , Ollie Desrochers , Melanie Zemel , Cassandra Saphirak , Jeremy Malin , Rosalie Torres Stone , Sonal Singh , Sybil Crawford , Kathleen M. Mazor
{"title":"Reasons for COVID-19 vaccination late in the pandemic: A qualitative study","authors":"Kimberly A. Fisher , Lydia Goldthwait , Ollie Desrochers , Melanie Zemel , Cassandra Saphirak , Jeremy Malin , Rosalie Torres Stone , Sonal Singh , Sybil Crawford , Kathleen M. Mazor","doi":"10.1016/j.vaccine.2025.127084","DOIUrl":"10.1016/j.vaccine.2025.127084","url":null,"abstract":"<div><div>This study elicited reasons for initiating COVID-19 vaccination in April 2022 or later. We interviewed patients (<em>n</em> = 51) from 2 healthcare systems in central Massachusetts. Participants were 66.7 % female, 39.2 % White non-Hispanic, 15.7 % Black non-Hispanic, and 39.2 % Hispanic. The most common reason for vaccination was that it was required for something the participant wanted to do, cited by 40/51 participants as the main reason for vaccination. Social influences, reported by 27/51 participants, were mostly (<em>n</em> = 22/27) described as secondary reasons. Increased disease risk appraisal and/or increased confidence in the vaccine were noted by 24/51 participants, also predominantly as secondary reasons (<em>n</em> = 14/24). Requirements to be vaccinated for work, school, or to participate in activities are an important lever for promoting COVID-19 vaccine uptake. Commonly cited as secondary reasons, social influences and factors that increase disease risk appraisal and/or vaccine confidence may serve to create a foundation for vaccine requirements.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127084"},"PeriodicalIF":4.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}