Vaccines最新文献

{"title":"A Quantitative Exploration of the Relationship Between Healthcare Accessibility and Mass Media in Nigeria Using the Levesque Framework of Healthcare Access.","authors":"Chelsea Gordon, Teresa Paslawski, Thilina Bandara, Shannon Floer, Tayyab Shah","doi":"10.3390/vaccines13090981","DOIUrl":"10.3390/vaccines13090981","url":null,"abstract":"<p><p><b>Background/Objectives</b>: This study investigates the relationship between maternal media access and childhood immunization status in Nigeria using the Levesque Framework for Healthcare Access. <b>Methods</b>: Utilizing data from the 2021 MICS-NICS survey, the study analyzes sociodemographic and media/ICT variables through logistic regression and geospatial mapping. <b>Results</b>: The results indicate that region is the strongest predictor of immunization status, with significant disparities in access to media and healthcare services across Nigeria. Television exposure was associated with improved immunization outcomes, while mobile phone ownership was not. <b>Conclusions</b>: The findings emphasize the importance of equitable media access and tailored health communication strategies to improve healthcare accessibility. The study highlights the need for region-specific interventions and continued monitoring of media access trends to support universal health coverage goals.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474090/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178841","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}

{"title":"GMP Manufacturing and Characterization of the HIV Booster Immunogen HxB2.WT.Core-C4b for Germline Targeting Vaccine Strategies.","authors":"Sammaiah Pallerla, Latha Kallur Siddaramaiah, Philipp Mundsperger, Dietmar Katinger, Katharina Fauland, Günter Kreismayr, Robert Weik, Onur Arslan, Mingchao Shen, Gabriel Ozorowski, Wen-Hsin Lee, Andrew B Ward, Sabyasachi Baboo, Jolene K Diedrich, John R Yates, James C Paulson, Tracy Blumen, Daniel Craig, Ryan Swoyer, Maoli Yuan, Leonidas Stamatatos","doi":"10.3390/vaccines13090980","DOIUrl":"10.3390/vaccines13090980","url":null,"abstract":"<p><strong>Background/objectives: </strong>Despite progress in antiretroviral therapy, HIV remains a major global health challenge with over one million new infections annually. An effective vaccine is urgently needed. Germline-targeting immunogens show promise in initiating broadly neutralizing antibody (bNAb) precursors. This study developed a scalable, cGMP-compliant process to manufacture the HIV vaccine booster immunogen HxB2.WT.Core-C4b, a nanoparticle designed to direct bNAb precursor maturation after priming.</p><p><strong>Methods: </strong>A CHO cell platform was established through single-cell cloning from a high-producing stable pool. Upstream and downstream processes were optimized for scalability and yield. Three scales were tested 10 L, 40 L, and 400 L. Key parameters (pH, temperature, feeding, metabolite profiles) were systematically refined. Analytical characterization included glycosylation profiling, electron microscopy, and antigenicity testing. Viral clearance was evaluated per ICH Q5A guidelines.</p><p><strong>Results: </strong>Optimization ensured consistent yields above 130 mg/L, with titers up to 250 mg/L. The selected clone (4E22) demonstrated strong growth, viability, and reproducibility. Glycan occupancy at 18 N-linked sites, including bNAb epitopes (N276, N332), was stable across scales. Over 70% of self-assembling nanoparticle were fully assembled at the GMP level. Antigenicity and purity met cGMP release criteria. Viral clearance achieved >13-log reduction for enveloped and >7-log for non-enveloped viruses.</p><p><strong>Conclusions: </strong>This work establishes a robust, scalable platform for HIV nanoparticle immunogens. Consistent quality and yield across scales support clinical development of HxB2.WT.Core-C4b and provide a model for other glycosylated nanoparticle vaccines. The immunogen is being evaluated in clinical study HVTN 320 (NCT06796686), enabling early testing of next-generation vaccines designed to elicit broadly neutralizing antibodies.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178831","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}

{"title":"Novel Strategies for Developing Next-Generation Vaccines to Combat Infectious Viral Diseases.","authors":"Fangfeng Yuan, Martin H Bluth","doi":"10.3390/vaccines13090979","DOIUrl":"10.3390/vaccines13090979","url":null,"abstract":"<p><p>The development of viral vaccines faces persistent scientific and logistical challenges, particularly in the wake of the COVID-19 pandemic. This review critically examines emerging strategies to overcome key barriers in viral vaccine design and deployment. We focus on four major areas: (1) structure-guided antigen engineering to stabilize conformations; (2) the mRNA platform and its delivery system; (3) advanced adjuvant systems that enhance cellular and humoral immunity; and (4) approaches to mitigate immune imprinting and antigenic variability, such as chimeric antigens and glycan shielding. We also explore anti-idiotypic vaccination strategies and the limitations of current animal models in predicting human immune responses. In addition, to address vaccine hesitancy and inequitable access, we advocate for global collaboration in manufacturing, distribution, and public education to ensure inclusive immunization strategies. By integrating molecular insights with platform technologies, we aim to inform the rational design of future vaccines with improved efficacy and public acceptance.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178832","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}

{"title":"Recent Advancements in Non-Invasive Vaccination Strategies.","authors":"Mahek Gulani, Tanisha Arte, Amarae Ferguson, Dedeepya Pasupuleti, Emmanuel Adediran, Yash Harsoda, Andrew Nicolas McCommon, Rikhav Gala, Martin J D'Souza","doi":"10.3390/vaccines13090978","DOIUrl":"10.3390/vaccines13090978","url":null,"abstract":"<p><p>Vaccines remain one of the most powerful tools in modern medicine, having revolutionized public health by preventing millions of deaths and controlling the spread of infectious diseases worldwide. However, conventional needle-based vaccines face several limitations, including pain and discomfort, the need for cold-chain infrastructure, reliance on trained healthcare personnel, risk of cross-contamination, and limited accessibility in low-resource settings. These challenges have spurred the development of non-invasive vaccination approaches that promise safer, more accessible, and patient-friendly immunization. Non-invasive immunizations not only eliminate the need for needles but may also enhance compliance and enable mucosal immune responses. To harness the full potential of these innovative delivery routes, a comprehensive understanding of their formulation strategies and mechanism of action is essential. This review aims to comprehensively discuss recent advancements in oral, intranasal, microneedle, buccal, sublingual, and vaginal vaccinations and highlight their underlying immunological mechanisms, formulation strategies in preclinical studies, examples of marketed products, and ongoing clinical trials.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178963","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}

{"title":"CD63-Mediated SARS-CoV-2 RBD Fusion Neoantigen DNA Vaccine Enhances Antitumor Immune Response in a Mouse Panc02 Model via EV-Targeted Delivery.","authors":"Guang Liu, Ziqing Yuan, Ziyi Wu, Qiyv Yang, Tingbo Ding, Ker Yu, Jibin Dong","doi":"10.3390/vaccines13090977","DOIUrl":"10.3390/vaccines13090977","url":null,"abstract":"<p><strong>Background: </strong>Although DNA vaccines offer a flexible platform for tumor immunotherapy, their weak immunogenicity remains a key limitation. This study aimed to improve the immunogenicity of DNA vaccines by enhancing the efficiency of tumor neoantigen delivery through extracellular vesicles (EVs), thereby promoting stronger dendritic cell (DC) activation and antitumor responses.</p><p><strong>Methods: </strong>A novel DNA vaccine (pCSP) was engineered by fusing tumor-specific neoantigens to the EV-associated protein CD63 and incorporating a SARS-CoV-2 receptor-binding domain (RBD) fragment to facilitate EV uptake by DCs. The resulting EVs were expected to carry neoantigens into the immunoproteasome for major histocompatibility complex I (MHC-I) presentation. The immunological and antitumor effects of pCSP were assessed through in vitro functional assays and in vivo experiments in a murine pancreatic cancer model. Safety was evaluated through histological and biochemical analyses.</p><p><strong>Results: </strong>In vitro, pCSP significantly promoted EV internalization by DCs by approximately twofold and enhanced their immune activation, as evidenced by elevated cytokine production. In vivo, pCSP markedly suppressed tumor growth with a decrease in volume by over 70% relative to controls, boosted CD8+ T cell responses, and increased immune infiltration into the tumor microenvironment. Safety assessments revealed that while liver/kidney function markers were within physiological ranges, mild inflammatory infiltrates were consistently observed in the lungs, indicating a localized safety concern that warrants further monitoring.</p><p><strong>Conclusions: </strong>The pCSP vaccine enhances the immunogenicity of neoantigen DNA vaccines by improving EV uptake and immune activation in DCs. These findings provide a potential strategy for improving DNA vaccine efficacy in the context of cancer immunotherapy while maintaining acceptable safety.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178903","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}

{"title":"Messenger RNA and Plasmid DNA Vaccines for the Treatment of Cancer.","authors":"Jena E Moseman, Daeun Shim, Donghwan Jeon, Ichwaku Rastogi, Kaitlyn M Schneider, Douglas G McNeel","doi":"10.3390/vaccines13090976","DOIUrl":"10.3390/vaccines13090976","url":null,"abstract":"<p><p>Immunotherapy is now an established therapy for nearly a third of patients with cancer. Most therapies, typically using cytokines or checkpoint blockade therapy, rely on global activation of immune effector cells. The ability of vaccines to activate specific populations of cells has led to a renewed interest in their ability to treat cancers, either alone or with other immune therapies or other conventional therapies. The COVID-19 pandemic sparked a new interest in nucleic acid vaccines with the development of new technologies and the short manufacturing time for vaccine implementation. Nucleic acid-based cancer vaccines have been studied for decades, but have shown modest anti-tumor efficacy as monotherapies, as many of these vaccines encode for shared tumor-associated antigens (TAAs) and must overcome immune tolerance. New developments, technologies, routes of delivery, and combination therapies have paved the way for new approaches and clinical trials involving nucleic acid vaccines for the treatment of cancer. Here we review mRNA and pDNA vaccines for the treatment of cancer, including similarities and differences in their mechanisms of action, an overview of these treatment modalities in preclinical and clinical studies, methods to improve these vaccine strategies, and exciting new combination approaches in development.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178681","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}

{"title":"Long-Term Follow-Up of T Cell Immunity Against <i>Orthopoxviruses</i> in People Living with HIV After Vaccination and Natural Monkeypox Virus Infection.","authors":"Monika Lindemann, Stefanie Sammet, Felix Maischack, Gabriela Graf, Peter A Horn, Heidi Wiehler, Jessica Wunderling, Stefan Esser","doi":"10.3390/vaccines13090975","DOIUrl":"10.3390/vaccines13090975","url":null,"abstract":"<p><strong>Background/objectives: </strong>After the 2022 mpox outbreak also outside Africa, risk groups including people living with HIV (PLWH) were vaccinated with the Modified Vaccinia Ankara-Bavarian Nordic vaccine (MVA-BN). Previous data on PLWH showed that two vaccinations induced specific T cell responses in 64% of the patients and natural monkeypox virus (MPXV) infection in 100%. The initial T cell response assay took place at a median of approximately 100 days post-vaccination and 300 days post-infection.</p><p><strong>Methods: </strong>This study investigates the durability of T cell immunity in PLWH by retesting patients approximately two years after initial assessment. We were able to retest 27 of 33 vaccinated patients and 7 of 10 patients after MPXV infection. T cells were stimulated with the same orthopoxvirus-derived peptide pools as in the initial study, and interferon (IFN)-γ and interleukin (IL)-2 ELISpot assays were performed.</p><p><strong>Results: </strong>The ELISpot assays showed specific T cell responses in 59% and 86% of twice vaccinated and previously infected patients, respectively. Paired analysis revealed no significant differences between previous and current data (short- and long-term follow-up), with IL-2 ELISpot results showing positive correlations at both time points (<i>r</i> = 0.67, <i>p</i> = 0.0001). Long-term IFN-γ responses after MPXV infection were 4.3 times higher (<i>p</i> < 0.01), and IL-2 responses were 2.9 times higher (<i>p</i> = 0.05) than after vaccination.</p><p><strong>Conclusions: </strong>Our data indicates that T cell responses to <i>Orthopoxviruses</i> remain overall stable for 2-3 years in PLWH, with long-term immunity being stronger after natural MPXV infection than after two vaccinations.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178720","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}

{"title":"Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Healthy Children Aged 12 to 15 Months: A Phase III, Randomized, Double-Blind, Active-Controlled Clinical Trial.","authors":"Nancy Nazaire-Bermal, Ningning Jia, Maria Angela C Maronilla, Josemaria F Lopez, Gang Zeng, Wenbin Wu, Adrielle Bernice C Nimo, Chunfang Luan, Qianqian Xin","doi":"10.3390/vaccines13090973","DOIUrl":"10.3390/vaccines13090973","url":null,"abstract":"<p><p><b>Objectives</b>: The varicella vaccine (VarV) produced by Sinovac (Dalian) obtained World Health Organization (WHO) prequalification in November 2022. However, no direct comparative studies have been conducted between VarV and other WHO-prequalified varicella vaccines. The study aimed to assess the immunogenicity and safety of Sinovac's VarV compared with Merck Sharp & Dohme's (MSD) VARIVAX^® (Moorgate, London, UK) following a single dose administration. <b>Methods</b>: This Phase III, randomized, double-blind, active-controlled, non-inferiority trial was conducted in the Philippines. Healthy children aged 12 to 15 months were enrolled. Eligible participants were randomly assigned (1:1) to receive a single dose of varicella vaccine either manufactured by Sinovac (Test group) or MSD (Active control group). Immunogenicity was evaluated 6 weeks after vaccination by enzyme-linked immunosorbent assay (ELISA). The primary immunogenicity endpoint was seroresponse rate 6 weeks after vaccination. Seroresponse rate was defined as varicella-zoster virus (VZV) antibody concentration ≥ 10 mIU/mL in participants who were seronegative (antibody concentration < 10 mIU/mL) at baseline. The secondary endpoint was the corresponding geometric mean concentration (GMC). Adverse events (AEs) and serious adverse events (SAEs) were monitored for 6 weeks after vaccination. <b>Results</b>: Among the 484 participants analyzed, the seroresponse rates 6 weeks after vaccination were 98.85% and 98.88% in the Test group and Active control group, respectively, with a difference of -0.03% (95% CI: -3.10%, 2.99%), which exceeded the predefined non-inferiority margin of -10%. The corresponding GMCs were 35.73 mIU/mL and 37.34 mIU/mL, respectively, with the ratio of 0.96 (95% CI: 0.86, 1.06), also exceeding the predefined non-inferiority margin of 0.67. Furthermore, the incidence of adverse reactions (ARs) in the Test group was lower than that in the Active control group (38.08% vs. 55.51%). <b>Conclusions</b>: Sinovac's VarV demonstrated non-inferior immunogenicity to WHO-prequalified comparator vaccine (VARIVAX^®) and favorable safety profile. These findings indicated that VarV (Sinovac, Beijing, China) met WHO standards for varicella vaccine evaluation, supporting its global use consideration.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178929","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}

{"title":"Need for Invasive Meningococcal Disease Prevention Through Vaccination for Young Children in the Americas.","authors":"Gaurav Mathur, Joseph B Domachowske, Maria Gabriela Graña, Reena Ladak, Joanne M Langley, Oluwatosin Olaiya, Alysa Pompeo, Laura Taddei, Rodolfo Villena","doi":"10.3390/vaccines13090974","DOIUrl":"10.3390/vaccines13090974","url":null,"abstract":"<p><p><b>Background:</b> Invasive meningococcal disease (IMD) is an uncommon but potentially life-threatening condition, resulting in life-long sequelae or death in up to 20% of cases. Most IMD cases are caused by Neisseria meningitidis serogroups (Men) A, B, C, W, X, and Y. The highest IMD incidence is among children < 5 years of age (YOA). We reviewed IMD epidemiology data and existing national immunization programs (NIP) in the Americas and identify unmet needs to decrease IMD burden in young children. <b>Methods:</b> Using national surveillance data and published literature from 2006 to 2024, we evaluated the IMD burden and national vaccination strategies for children < 5 YOA in the Americas, focusing on Canada, the United States, Brazil, Chile, Argentina. <b>Results:</b> The highest IMD incidence was among infants, followed by children 1-4 YOA, with MenB infections predominating in both age groups. Chile has both MenACWY (2014) and MenB (2023) infant vaccination in its NIP. Argentina and Brazil's NIPs include MenACWY (2017) and MenC (2010) vaccinations for infants, respectively. In Canada, MenC (2002) vaccination is recommended at 1 YOA (replaced by MenACWY in 2024 in Manitoba); MenB vaccination is selectively recommended. In each country, the incidence of IMD caused by vaccine-preventable serogroups decreased following the introduction of the respective meningococcal vaccination in the NIP. <b>Conclusions:</b> Comprehensive meningococcal vaccination programs in the Americas have the potential to reduce the IMD burden in children < 5 YOA. National recommendations and NIPs could reduce IMD burden by offering equitable access to protection against IMD, aligning with the WHO roadmap to defeat meningitis by 2030.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178862","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}

{"title":"Safety and Immunogenicity of Single-Dose of Adsorbed Tetanus Vaccine in Adults Aged 18-44 Years: Randomized, Double-Blind, Positive-Controlled Phase I/III Clinical Trial.","authors":"Zhiqiang Xie, Liyong Yuan, Yaping Qiao, Wangyang You, Yurong Li, Taotao Zhu, Wei Zhang, Lili Huang, Jiebing Tan, Xiaocan Jia, Zhe Li, Feng Xue, Xiaojuan Lian, Yanxia Wang","doi":"10.3390/vaccines13090972","DOIUrl":"10.3390/vaccines13090972","url":null,"abstract":"<p><p><b>Background</b>: The persistence of non-neonatal tetanus (non-NT) highlights the necessity of adult booster vaccines and post-traumatic prophylaxis. This Phase I/III clinical trial aimed to evaluate the safety and immunogenicity of a new adsorbed tetanus vaccine. <b>Methods</b>: A randomized, double-blind, positive-controlled clinical trial was conducted in Henan Province, China. A total of 1258 healthy participants aged 18-44 years (60 in Phase I and 1198 in Phase III) were enrolled, with no history of tetanus infection, or tetanus toxoid-containing vaccines (TTCVs) vaccination within the past 10 years. The participants were randomly assigned at a 1:1 ratio to receive a single dose of either the investigational vaccine or the licensed control vaccine. The Phase III clinical trial was initiated subsequent to the 7-day safety observation period following vaccination in the Phase I trial. The objective of the Phase III clinical trial was to assess the non-inferiority of the seroconversion rate of tetanus antibodies at 30 days post-vaccination with the investigational vaccine compared to the control vaccine. Serum samples were collected prior to and at 30 days post-vaccination. Adverse events were monitored for 30 days, with serious adverse events (SAEs) followed up for 6 months post-vaccination. <b>Results</b>: The investigational group achieved a seroconversion rate of 99.48%, which was non-inferior to that of the control group (99.66%), with a negligible rate difference of -0.17% (95% confidence interval [CI]: -1.20%, 0.78%). The investigational group exhibited a significantly higher geometric mean concentration (GMC) of antibodies (4.721 IU/mL vs. 3.627 IU/mL, <i>p</i> < 0.0001). Among the susceptible participants, the seroconversion rates were 99.78% in the investigational group and 99.79% in the control group, respectively, with a non-inferior rate difference of -0.01% (95%CI: -1.06%, 0.97%). Furthermore, the investigational group showed a low incidence of adverse reactions (ARs) within 30 days post-vaccination (12.26%), which was comparable to that of the control group (13.65%). All the reported ARs were mild or moderate, and no SAEs were associated with the vaccination. <b>Conclusions</b>: The new adsorbed tetanus vaccine demonstrated favorable safety and comparable immunogenicity to the marketed control vaccine, with a significantly higher antibody GMC, supporting its clinical application in tetanus prevention.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 9","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179021","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}