Vaccine最新文献

{"title":"Comparison of SARS-CoV-2 antibody responses following the second dose of BNT162b2 and mRNA-1273 vaccines in people living with HIV-1","authors":"Masayuki Murata ,&nbsp;Yuji Matsumoto ,&nbsp;Nobuyuki Shimono","doi":"10.1016/j.vaccine.2025.127457","DOIUrl":"10.1016/j.vaccine.2025.127457","url":null,"abstract":"<div><h3>Background</h3><div>People living with human immunodeficiency virus type 1 (PLWH) are at increased risk for severe outcomes following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Although SARS-CoV-2 mRNA vaccines have demonstrated strong immunogenicity in general populations, comparative data regarding the humoral immune responses in PLWH remain limited. This study aimed to compare the humoral responses elicited by two widely used mRNA vaccines, BNT162b2 and mRNA-1273, in Japanese PLWH.</div></div><div><h3>Methods</h3><div>This observational study investigated 119 PLWH without prior SARS-CoV-2 infection who received two doses of BNT162b2 (<em>n</em> = 91) or mRNA-1273 (<em>n</em> = 28). Anti-SARS-CoV-2 spike antibody titers were measured at three time points: before vaccination and approximately 6 weeks and 24 weeks after the second vaccine dose. Factors associated with the antibody responses were analyzed by multivariate logistic regression.</div></div><div><h3>Results</h3><div>Both vaccines elicited robust antibody responses in PLWH, with the mRNA-1273 group having significantly higher antibody titers than the BNT162b2 group at 6 and 24 weeks (<em>P</em> &lt; 0.0001). Receipt of mRNA-1273 was independently associated with antibody titers ≥4160 AU/mL at 6 weeks (adjusted odds ratio, 24.1; 95 % confidence interval, 6.26–161) and ≥ 1000 AU/mL at 24 weeks (adjusted odds ratio, 21.7; 95 % confidence interval, 6.72–85.5). Other factors associated with higher antibody titers included younger age, higher CD4⁺ T cell count, and absence of smoking history. Despite the differences in the antibody levels, no severe COVID-19 infections occurred during the follow-up period.</div></div><div><h3>Conclusions</h3><div>BNT162b2 and mRNA-1273 both induce effective humoral responses in PLWH, with mRNA-1273 producing significantly higher and more durable antibody titers. The present findings support vaccine selection strategies tailored to immunocompromised populations and highlight the need for continued monitoring and consideration of booster doses.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127457"},"PeriodicalIF":4.5,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144597080","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}

{"title":"Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccine uptake among pregnant women (EPIC study) in Australia","authors":"Prabha H. Andraweera ,&nbsp;Bing Wang ,&nbsp;Margie Danchin ,&nbsp;Christopher C. Blyth ,&nbsp;Ivo Vlaev ,&nbsp;Jason J. Ong ,&nbsp;Jodie Dodd ,&nbsp;Jennifer Couper ,&nbsp;Thomas R. Sullivan ,&nbsp;Alana R. Cuthbert ,&nbsp;Jonathan Karnon ,&nbsp;Nicola Spurrier ,&nbsp;Michael Cusack ,&nbsp;Dylan Mordaunt ,&nbsp;Dimi Simatos ,&nbsp;Gus Dekker ,&nbsp;Samantha Carlson ,&nbsp;Jane Tuckerman ,&nbsp;Nicholas Wood ,&nbsp;Lisa Whop ,&nbsp;Helen S. Marshall","doi":"10.1016/j.vaccine.2025.127477","DOIUrl":"10.1016/j.vaccine.2025.127477","url":null,"abstract":"<div><h3>Background</h3><div>Influenza and COVID-19 vaccine uptake among pregnant women is sub-optimal. We assessed the effectiveness of a multi-component behavioural nudge intervention to improve COVID-19 and influenza vaccine uptake among pregnant women.</div></div><div><h3>Methods</h3><div>A ‘nudge’ was developed that comprised three SMS text message reminders with a social norming message, links to vaccine safety information, videos of health professionals and consumers recommending vaccination in pregnancy and a pledge to get vaccinated. In separate RCTs, pregnant women who had not received an influenza vaccine during the 2023 influenza season, or received ≤2 doses of a COVID-19 vaccine, were randomised (1:1) to standard care or intervention at four hospitals in Australia.</div></div><div><h3>Results</h3><div>A total of 1090 and 1068 pregnant women were randomised to the COVID-19 and influenza RCTs, respectively. The nudges resulted in a 1.6 % increase in COVID-19 vaccine uptake and 1.7 % increase in influenza vaccine uptake among pregnant women. However, there was no significant difference in the percentage of pregnant women in the intervention (2.7 %) and the standard care (1.1 %) groups receiving one dose of a COVID-19 vaccine from randomisation until delivery (odds ratio, 2.40; 95 % confidence interval [CI], 0.91 to 6.30, <em>P</em> = 0.08). Similarly, there was no significant difference in the percentage of pregnant women in the intervention (58.0 %) and the standard care (56.3 %) groups receiving the influenza vaccine from the time of randomisation until delivery (odds ratio, 1.07; 95 % CI, 0.84 to 1.38, <em>P</em> = 0.58). Less than 2 % of women had viewed the video content of the nudges in both RCTs.</div></div><div><h3>Conclusions</h3><div>The nudges delivered via SMS resulted in small increases in COVID-19 and influenza vaccination uptake among pregnant women. Considering the very low cost of bulk SMS, these nudges may be cost-effective interventions at a population level.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127477"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580638","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}

{"title":"Engaging a community health ambassador model to promote COVID-19 vaccine in three Massachusetts communities","authors":"Kamini Mallick ,&nbsp;Veronica L. Handunge ,&nbsp;Karen M. Emmons ,&nbsp;Lissette Blondet ,&nbsp;Doris Harris ,&nbsp;Liv Anna Homstead ,&nbsp;Jessica Collins ,&nbsp;Isabel Lopez ,&nbsp;Rebekka M. Lee","doi":"10.1016/j.vaccine.2025.127464","DOIUrl":"10.1016/j.vaccine.2025.127464","url":null,"abstract":"<div><div>The COVID-19 vaccine rollout in the United States had significant disparities with Black, Hispanic, and other historically marginalized populations experiencing lower vaccination rates compared to white residents. In response, the Centers for Disease Control and Prevention funded Prevention Research Centers across the country to establish the Vaccine Confidence Network. The Harvard Prevention Research Center (HPRC) partnered with community-based organizations (CBOs) in three of the hardest-hit cities in Massachusetts. CBOs implemented a community health ambassador model, hiring community members who leveraged their skills and connections to conduct tailored vaccine outreach. The HPRC team provided financial and technical support, developing outreach materials that kept up with continuously shifting COVID-19 guidance. We used a mixed-methods evaluation to assess outreach activities through surveys tracking the number of individuals reached and semi-structured interviews with health ambassadors on their experiences. Over ten months, health ambassadors conducted vaccine outreach in a wide range of places like bus stops, school welcome centers, grocery stores, and community events and reached a variety of populations including immigrants, parents of younger children, African Americans, and more. Ambassadors interviewed reflected positive experiences with vaccine outreach, as it increased their confidence in understanding public health data and engaging with people about public health issues. This study emphasizes the value of partnering with community organizations to effectively engage diverse populations and highlights the potential for building local public health capacity through community health ambassadors to address future health challenges.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127464"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580474","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}

{"title":"SARS-CoV-2 breakthrough infection during pregnancy preferentially elicits IgG4 response and enhanced placental-transfer","authors":"Sheridan B. Wagner ,&nbsp;Monica Rincon ,&nbsp;Katelyn E. Keen ,&nbsp;Gregory S. Hawk ,&nbsp;Nicole E. Marshall ,&nbsp;Ilhem Messaoudi","doi":"10.1016/j.vaccine.2025.127476","DOIUrl":"10.1016/j.vaccine.2025.127476","url":null,"abstract":"<div><h3>Background</h3><div>Emerging SARS-CoV-2 variants and waning humoral immunity have led to increased occurrences of breakthrough infection. Pregnant individuals and neonates are particularly vulnerable to adverse outcomes associated with COVID-19.</div></div><div><h3>Objective</h3><div>We aimed to evaluate the maternal anti-SARS-CoV-2 IgG response and the placental transfer of antibodies to the fetus following breakthrough infection, infection in unvaccinated participants, and vaccination in the absence of infection during pregnancy.</div></div><div><h3>Methods</h3><div>Pregnant patients (<em>n</em> = 165) were enrolled at Oregon Health &amp; Science University and assigned to three cohorts based on infection and vaccination status. Receptor-binding domain (RBD) and nucleocapsid protein (NP) specific IgG endpoint titers (EPT) and optical density (OD) values were determined via ELISA longitudinally in maternal blood and breastmilk, and at delivery in paired maternal, umbilical cord, and newborn blood.</div></div><div><h3>Results</h3><div>Breakthrough infection in vaccinated participants induced a higher maternal RBD-specific IgG response compared to infection or vaccination alone in maternal plasma and breastmilk. As reported with repeated vaccination, breakthrough infection skewed RBD-specific IgG responses toward an IgG4 response. IgG1 and IgG3 were the dominant NP-specific subclasses for both breakthrough infection and unvaccinated/infection groups. The breakthrough infection cohort had the highest newborn-to-maternal ratio of RBD-specific IgG with a strong correlation between maternal and newborn delivery titers.</div></div><div><h3>Conclusion</h3><div>Breakthrough infection during pregnancy prolongs pre-existing humoral immunity and facilitates the transplacental transfer of antibodies to the neonate, reflecting an antibody priming effect induced by prior vaccination rather than infection alone. These results warrant continued administration of updated SARS-CoV-2 vaccination during pregnancy to reduce disease severity and provide greater protection to newborns.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127476"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580637","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}

{"title":"Trends in the development of nanovaccines against swine diseases","authors":"H. León-Montoya,&nbsp;C. Angulo","doi":"10.1016/j.vaccine.2025.127491","DOIUrl":"10.1016/j.vaccine.2025.127491","url":null,"abstract":"<div><div>Swine diseases lead to significant economic losses to the pork industry and pose a risk of zoonotic transmission. To address this issue, nanomaterials are being used as carriers for antigens, including inactivated viruses, chimeric proteins, membrane proteins, and genetic materials such as DNA. Nanovaccines have been administered through intranasal, subcutaneous, and intramuscular routes, with some showing strong immune responses and protective efficacy against pathogenic challenges. This review highlights the current trends in developing nanovaccines for swine diseases, focusing on the employed nanomaterials, their physicochemical properties, delivery strategies, immune responses, and protective outcomes. It also examines the challenges and potential future applications of nanovaccines in the swine industry.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127491"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580636","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}

{"title":"Neutralizing antibody evasion of SARS-CoV-2 JN.1 derivatives KP.3, KP.3.1.1, LB.1, and XEC","authors":"Kaori Sano ,&nbsp;Kei Miyakawa ,&nbsp;Hideaki Kato ,&nbsp;Yayoi Kimura ,&nbsp;Atsushi Goto ,&nbsp;Akihide Ryo ,&nbsp;Shinji Watanabe ,&nbsp;Hideki Hasegawa","doi":"10.1016/j.vaccine.2025.127472","DOIUrl":"10.1016/j.vaccine.2025.127472","url":null,"abstract":"<div><div>The emergence of SARS-CoV-2 variants poses ongoing challenges to vaccine efficacy. We evaluated neutralizing antibody responses against JN.1 and its derivatives (KP.3, KP.3.1.1, LB.1, and XEC) in healthcare workers who received seven doses of BNT162b2, including the XBB.1.5 monovalent vaccine. In COVID-19-naïve individuals, KP.3.1.1 and LB.1 showed substantial immune escape, whereas previously infected individuals maintained neutralization activity against all variants. We also demonstrated that JN.1-based immunization induces robust cross-neutralizing activity against emerging variants. A single amino acid deletion at position 31 in the spike protein may be associated with enhanced immune evasion. These findings support the potential effectiveness of JN.1-based vaccines while highlighting the need for continued surveillance and vaccine optimization.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127472"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144588913","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}

{"title":"Accuracy of online surveys in predicting COVID-19 uptake and demand: A cohort study investigating vaccine sentiments and switching in 13 countries from 2020 to 2022","authors":"Zachary D.V. Abel ,&nbsp;Laurence S.J. Roope ,&nbsp;Mara Violato ,&nbsp;Philip M. Clarke","doi":"10.1016/j.vaccine.2025.127450","DOIUrl":"10.1016/j.vaccine.2025.127450","url":null,"abstract":"<div><div>During pandemic conditions, efficient use of resources is essential, but vaccine hesitancy threatens to render vaccine deployment ineffective and inefficient. This study investigated the sensitivity and specificity of a straightforward ex-ante online survey question in predicting ex-post vaccine uptake, and the sociodemographic characteristics associated with individual changes (e.g., false positive or negative responses) in vaccine preferences. We conducted a pooled analysis on stated vaccine preferences and self-reported uptake of a convenience sample of 5213 individuals who were sampled in 13 countries in 2020/21 and 2022. We found online survey response of vaccine intention to be a strong determinant of vaccine uptake. The survey sensitivity was 80.5 %, while specificity was 51.8 %. Though we found evidence of stronger consistency between ex-ante intention and ex-post action in university educated respondents, and weaker consistency amongst those with right leaning political tendencies, further work is required to generalize these results by using representative datasets within each country. In situations where health technologies need to be rolled out urgently, simple and rapid surveys linked to individual health profiles have potential to increase the speed and efficiency of deployment (e.g., Personal Level Integrated Data Asset (PLIDA) in Australia), though low specificity threatens to undermine efficiency gains and sensitivity requirements in risk-averse medical decision making settings may be beyond the capabilities of simple surveys.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127450"},"PeriodicalIF":4.5,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571447","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}

{"title":"School-based interventions to increase influenza vaccination in primary school students","authors":"Mengmeng Jia ,&nbsp;Yanlin Cao ,&nbsp;Xin Mu ,&nbsp;Dafei Ren ,&nbsp;Jiuquan Ai ,&nbsp;Cai Yang ,&nbsp;Ping Zhang ,&nbsp;Yuxi Liu ,&nbsp;Yuandong Hu ,&nbsp;Luzhao Feng","doi":"10.1016/j.vaccine.2025.127442","DOIUrl":"10.1016/j.vaccine.2025.127442","url":null,"abstract":"<div><h3>Background</h3><div>Addressing low vaccination coverage in primary school students will help prevent influenza outbreaks and safeguard public health. We evaluated the effectiveness of school-based interventions in improving influenza vaccination rates among primary school students in Guizhou, China.</div></div><div><h3>Methods</h3><div>Parents and students from four primary schools participated in December 2023. Basic information and vaccination history were collected at baseline and on April 30, 2024, respectively. Among the 9437 included students, 9168 (97·15 %) were not vaccinated during the 2023–2024 winter season. In one school, parents received informational material (Information group); in another, children received on-campus influenza vaccination services (SIV group). A third school received both informational material and vaccination services (Information+SIV group). The fourth was the control group, receiving no intervention.</div></div><div><h3>Findings</h3><div>Since the intervention, 1·11 % (19/1713) of previously unvaccinated students in the 2023–2024 season were vaccinated in the control group. Vaccination rates were significantly higher in the Information (5·30 %, <em>P</em> &lt; 0·001), SIV (13·99 %, <em>P</em> &lt; 0·001), and Information+SIV groups (12·96 %, P &lt; 0·001) than in the control group. The SIV and Information+SIV groups had higher vaccination rates than the Information group (P &lt; 0·01), with no significant difference between the SIV and Information+SIV groups (<em>P</em> = 0·28). Among the 853 vaccinated students, 44·78 % (<em>n</em> = 382) were first-time recipients. Those with prior vaccination history had a higher likelihood of vaccination than their counterparts. Students in grades 5–6 and some ethnic minority groups had a lower likelihood of vaccination.</div></div><div><h3>Interpretation</h3><div>School-based interventions, particularly on-campus vaccinations, can increase vaccination rates among primary school students.</div></div><div><h3>Funding</h3><div>Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (grant number: 2022-12 M-CoV19–004), Science &amp; Technology Fundamental Resources Investigation Program (grant number: 2023FY100600), Gates Foundation (grant number: INV-023808, INV-006373), and Health Commission of Guizhou Province (grant number: gzwkj2024–215).</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127442"},"PeriodicalIF":4.5,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571449","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}

{"title":"IFITM3-deficient mice as a model for testing influenza virus vaccines via the intramuscular route","authors":"Adrian C. Eddy ,&nbsp;Samuel Speaks ,&nbsp;Megan Roth,&nbsp;Jack E. Roettger,&nbsp;Brendan M. Reznik,&nbsp;Shreenath Mohan,&nbsp;Ben D. Liu,&nbsp;Emily A. Hemann,&nbsp;Jacob S. Yount","doi":"10.1016/j.vaccine.2025.127458","DOIUrl":"10.1016/j.vaccine.2025.127458","url":null,"abstract":"<div><div>Influenza virus infections remain a significant global health concern. Development of a universal influenza vaccine has been met with challenges, in part due to difficulties with preclinical vaccine testing in mice, which are widely available but are often poorly infected with human and avian influenza viruses. Here, we investigate whether mice lacking interferon-induced transmembrane protein 3 (IFITM3), an antiviral restriction factor, provide a suitable preclinical model for vaccine testing since we observe enhanced replication of multiple influenza virus strains in these mice. We find that IFITM3 KO mice produce a blunted antibody response to intramuscular vaccination that is increased by a booster dose. Nonetheless, their adaptive immune responses to previous infections and vaccinations were found to be functional in limiting weight loss, survival, and viral replication in challenge studies. Overall, our findings identify IFITM3 KO mice as an accessible, functionally immunocompetent preclinical model for assessment of influenza vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127458"},"PeriodicalIF":4.5,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571446","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}

{"title":"Immunogenicity, safety and immunological memory of a Brazilian meningococcal C conjugate vaccine on a phase II clinical trial","authors":"Reinaldo de Menezes Martins ,&nbsp;Célia Menezes Cruz Marques ,&nbsp;Tatiana Guimarães de Noronha ,&nbsp;Elyne Montenegro Engstrom ,&nbsp;Carla da Silva Sepúlveda ,&nbsp;Luiz Antonio Bastos Camacho ,&nbsp;Denise Cristina de Souza Matos ,&nbsp;Andrea Marques Vieira da Silva ,&nbsp;Maria de Lourdes Moura Leal ,&nbsp;Ellen Jessouroun ,&nbsp;Raissa Coelho Andrade ,&nbsp;Akira Homma ,&nbsp;Ivna Alana Freitas Brasileiro da Silveira ,&nbsp;Maria de Lourdes de S. Maia","doi":"10.1016/j.vaccine.2025.127419","DOIUrl":"10.1016/j.vaccine.2025.127419","url":null,"abstract":"<div><div>Introduction: Meningococcal disease (MD) is a public health burden. In many countries, including Brazil, serogroup C (MenC) is the main cause of MD, emphasizing the importance of continuous improvement of MenC conjugate vaccines. Methods: Phase II randomized, single-blinded study, with 360 healthy and meningococcal vaccine-naive children from 1 to 9 years of age: 240 received the candidate MenCC-Bio vaccine and 120 received the reference vaccine Neisvac-C®. The test vaccine was developed by Bio-Manguinhos∕Fiocruz and contained per dose: meningococcal C polysaccharide 10 μg (strain 2135) conjugated to tetanus toxoid (10–30 μg), and aluminum hydroxide (0.35 mg Al⁺³). Seroconversion (<em>i.e.</em>, conversion to ≥1:8 or a 4-fold increase in serum bactericidal activity titers) and geometric mean titers (GMT) were evaluated. Adverse events were recorded for 30 days following vaccination. Duration of seroprotection was assessed 12 months after primary vaccination, and a booster dose was administered in children who had seroconverted initially. Results: Seroconversion rates were 226/240 (94.2 %; 95 % CI: 91.0 %; 96.4 %) for MenCC-Bio and 118/120 (98.3 %; 95 % CI: 94.1 %; 99.8 %) for Neisvac-C®. MenCC-Bio was considered non-inferior (difference in seroconversion −4.1 %; 95 % CI: −8.5 %; 0.3 %). However, post-vaccination bactericidal GMT was inferior (MenCC-Bio = 230; Reference vaccine = 1036), and test/reference GMT post-vaccination ratio was 0.22 (non-inferiority cutoff ≥0.6). Differences in immunogenicity were higher for children &lt;5 years old. In the subset of children reassessed after 12 months, seroreversion for MenCC-Bio was 80.1 % and 46.0 % for the reference vaccine. Post-revaccination GMT was higher than after primary vaccination, and all seronegative volunteers became seropositive, indicating strong immunological memory. Both vaccines were well tolerated, and adverse events were mild or moderate. Conclusion: MenCC-Bio vaccine was equally safe but had lower immunogenicity compared to Neisvac-C®. Nevertheless, the high seroconversion rate and induction of immunological memory indicates its usefulness in Immunization Programs.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127419"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144570522","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}