Vaccines最新文献

{"title":"An Open-Label, Randomized Field Trial Demonstrates Safety and Immunogenicity of Inactivated gE-Deleted Marker Vaccine Against Infectious Bovine Rhinotracheitis in Cattle.","authors":"Bhaskar Ganguly, Sarvesh Tayshete, Deepa Padinjare Melepat, Sudhakar Awandkar, Srinivas Karnati, Priyabrata Pattnaik, Anand Kumar Kanakasapapathy","doi":"10.3390/vaccines13060579","DOIUrl":"10.3390/vaccines13060579","url":null,"abstract":"<p><p><b>Background</b>: Infectious Bovine Rhinotracheitis (IBR), Infectious Pustular Balanoposthitis (IPB), Infectious Pustular Vulvovaginitis (IPV), late-term abortions, and neurological and systemic disease are common manifestations of Bovine Herpesvirus-1 (BoHV-1) infections. IBR is enzootic to India and several other countries across the world. Globally, both live attenuated and inactivated vaccines are available commercially for the control of the disease. This communication reports the results of an open-label, randomized field trial of an inactivated IBR marker vaccine in cattle. <b>Methods</b>: An indigenously developed, inactivated, glycoprotein-E (gE)-deleted marker vaccine was subjected to a field trial involving 90 healthy cattle of more than three months of age, evaluating its safety and immunogenicity. <b>Results</b>: Vaccination was safe without any adverse and serious adverse events, except a self-limiting and self-subsiding induration at the site of injection in a few cases. The vaccine caused elevation of body temperature but within normal physiological range; no derangements in feed intake or milk yield were recorded. A total of 90% of the subjects developed protective titers of SNT₅₀ ≥ 8 after receiving both doses of initial vaccination and maintained protective titers until 180 days thereafter. <b>Conclusions</b>: Altogether, our findings uphold that the indigenously developed, inactivated gE-deleted marker vaccine against IBR is safe and results in protective levels of immunity for at least six months in cattle of more than three months of age.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508503","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":"A Poly-Lysine-Based RBD Mucosal Vaccine Induces Potent Antibody Responses in Mice.","authors":"Huifang Xu, Han Wang, Peng Sun, Tiantian Wang, Bin Zhang, Xuchen Hou, Jun Wu, Bo Liu","doi":"10.3390/vaccines13060582","DOIUrl":"10.3390/vaccines13060582","url":null,"abstract":"<p><p>(1) Background: The COVID-19 pandemic highlights the critical necessity for the development of mucosal vaccines. (2) Objective: In this study, we aimed to develop mucosal vaccines based on the receptor-binding domain (RBD) of the SARS-CoV-2 Spike protein. (3) Methods: We engineered the RBD of the Spike protein by incorporating ten lysine residues (K10), thereby enhancing its positive charge under physiological conditions. (4) Results: Although this modification did not directly augment the immunogenicity of the antigen, its combination with the mucosal adjuvant cholera toxin B subunit (CTB) and administration via the pulmonary route in BALB/c mice resulted in the induction of robust neutralizing antibody titers. Antigen-specific antibody responses were observed in both serum and bronchoalveolar lavage fluid. Importantly, serum IgG antibody titers remained above 10⁴ six months following third immunization, suggesting the establishment of sustained long-term immunity. Additionally, the incorporation of five lysine residues (K5) into the RBD, in conjunction with CTB, significantly increased serum IgG and IgA antibody titers. (5) Conclusions: Adding poly-lysine to RBD and combining it with CTB can stimulate robust mucosal and humoral immune responses in mice. These findings offer valuable insights for the design of subunit mucosal vaccines.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508482","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":"Optimized Production of Virus-like Particles in a High-CHO-Cell-Density Transient Gene Expression System for Foot-and-Mouth Disease Vaccine Development.","authors":"Ana Clara Mignaqui, Alejandra Ferella, Cintia Sánchez, Matthew Stuible, Romina Scian, Jorge Filippi, Sabrina Beatriz Cardillo, Yves Durocher, Andrés Wigdorovitz","doi":"10.3390/vaccines13060581","DOIUrl":"10.3390/vaccines13060581","url":null,"abstract":"<p><strong>Background/objectives: </strong>Foot-and-mouth disease virus (FMDV) poses a continuous threat to livestock health and agricultural economies. Current vaccines require high biosafety standards and are costly to produce. While novel vaccine technologies have been explored, most fail to meet industrial scalability, cost-efficiency, or multiserotype flexibility required for effective FMD control. This study aimed to evaluate the feasibility of using a high-cell density transient gene expression (TGE) system in CHO cells for the production of FMDV virus-like particles (VLPs) as a recombinant vaccine platform.</p><p><strong>Methods: </strong>VLP expression was optimized by adjusting cDNA and polyethyleneimine (PEI) concentrations. Expression yields were compared at 24 and 48 h post-transfection to determine optimal harvest timing. We further tested the system's capacity to express different serotypes and chimeric constructs, incorporating VP1 sequences from various FMDV strains. Immunogenicity was evaluated in swine using VLPs from the A2001 Argentina strain as a model.</p><p><strong>Results: </strong>Optimal VLP expression was achieved at 24 h post-transfection. Chimeric constructs incorporating heterologous VP1 regions were successfully expressed. Immunized pigs developed protective antibody titers as measured by a virus neutralization test (VNT, log₁₀ titer 1.43) and liquid-phase blocking ELISA (LPBE, titer 2.20) at 28 days post-vaccination (dpv). Titers remained above protective thresholds up to 60 dpv with a single dose. A booster at 28 dpv further elevated titers to levels comparable to those induced by the inactivated vaccine.</p><p><strong>Conclusions: </strong>Our results demonstrate the feasibility of using CHO cell-based TGE for producing immunogenic FMDV VLPs. This platform shows promise for scalable, cost-effective, and biosafe development of recombinant FMD vaccines.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508502","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":"Intervention Strategies to Overcome HPV Vaccine Hesitancy Among Hispanic Immigrants in the USA: A Video-Based Approach.","authors":"Isaiah Aduse-Poku, Diego A Ardon, Alexis B Call, Spencer C Davis, Preston Evans, Spencer Johanson, Ruth J Larson, James Rencher, Isaac A Woolley, Brian D Poole, Jamie L Jensen","doi":"10.3390/vaccines13060574","DOIUrl":"10.3390/vaccines13060574","url":null,"abstract":"<p><strong>Background/objectives: </strong>Hispanic immigrants (HIs) in the U.S.A. are disproportionately affected by cervical cancer compared to other groups, at least partly due to low HPV vaccination rates. The aim of this study was to investigate strategies to improve HPV vaccine attitudes and intent of HIs in the U.S.A. by developing and testing the effectiveness of video-based interventions.</p><p><strong>Methods: </strong>This study employed a two-phase mixed-methods approach. In the first phase, focus groups with new and established HIs explored perspectives, concerns about HPV vaccination, types of information to include in a video intervention, and how an effective intervention should be designed. Findings from the focus groups guided the creation of seven short educational videos, including a summary video and a testimonial-based video, addressing key questions about HPV and its vaccine. The second phase, which involved a nationwide survey of 1500 Spanish-speaking HIs, revealed a significant change in overall HPV vaccine attitude generally, and a significant increase in both HPV vaccine intent and attitudes among parents of unvaccinated children.</p><p><strong>Results: </strong>Regression analysis revealed general vaccine attitudes (β = 0.620, <i>p</i> < 0.001), English proficiency (β = 0.066, <i>p</i> = 0.01), and gender (β = -0.072, <i>p</i> = 0.002), as significant predictors of attitudinal changes. Notably, females exhibited less favorable post-intervention attitudes compared to males. Additionally, perceived care from video creators was a strong predictor of normalized gains in vaccine attitudes (β = 0.270, <i>p</i> < 0.001). Video content effectiveness varied; the video addressing vaccine side effects demonstrated the highest impact on attitude improvement. Testimonials and the summary video were also effective in fostering positive changes in attitudes. Despite differences in trust levels between new and established immigrants, both groups valued culturally tailored, Spanish-language information from credible sources.</p><p><strong>Conclusion: </strong>Addressing language and cultural barriers can improve trust in healthcare interventions among Hispanic immigrants in the U.S.A. Public health initiatives should consider these factors to more effectively reduce HPV vaccine hesitancy in this population.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508548","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":"Is Vaccine Uptake Related to Health Literacy? A Representative Survey in the Multilingual Region of South Tyrol, Italy.","authors":"Verena Barbieri, Dietmar Ausserhofer, Stefano Lombardo, Adolf Engl, Giuliano Piccoliori, Timon Gärtner, Christian J Wiedermann","doi":"10.3390/vaccines13060575","DOIUrl":"10.3390/vaccines13060575","url":null,"abstract":"<p><strong>Background/objectives: </strong>Vaccination rates in South Tyrol, Northern Italy, remain among the lowest in the country. This study investigated whether health literacy is associated with vaccine uptake in this multilingual region.</p><p><strong>Methods: </strong>A representative cross-sectional survey (<i>n</i> = 2090) was conducted using the validated European Health Literacy Survey Questionnaire (HLS-EU-Q16) to assess health literacy. Vaccine uptake was evaluated on a 4-point Likert scale and analysed by age group (18-54 years; ≥55 years). Associations were explored using ANCOVA and multivariate logistic regression models.</p><p><strong>Results: </strong>Among younger adults (18-54 years), higher health literacy was significantly associated with greater vaccine uptake, particularly when compared with individuals with missing health literacy data. Health literacy was not a significant predictor for vaccine uptake in the older age group (≥55 years). Instead, vaccine uptake correlated with trust in healthcare providers, the presence of chronic diseases, and educational level. Differences in health literacy were notable across language groups, but these did not interact with vaccination behaviour.</p><p><strong>Conclusions: </strong>Building trust and targeting individuals with lower educational attainment are key strategies for improving vaccination rates across language groups. Although health literacy plays a secondary role, efforts to enhance it, especially among the German-speaking population, are still warranted. Younger individuals with missing health literacy scores, often with a migration background and low trust in healthcare, should be prioritised in vaccination and health literacy campaigns.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508550","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":"Synergistic Antitumor Effects of Caerin Peptides and Dendritic Cell Vaccines in a 4T-1 Murine Breast Cancer Model.","authors":"Rongmi Mo, Junjie Li, Xinyi Song, Jiawei Fu, Mengqi Liu, Yuandong Luo, Quanlan Fu, Jinyi Wu, Hongyin Wu, Yongxin Liang, Tianfang Wang, Xiaosong Liu, Guoying Ni","doi":"10.3390/vaccines13060577","DOIUrl":"10.3390/vaccines13060577","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Breast cancer remains a leading cause of cancer-related mortality among women worldwide, necessitating novel therapeutic strategies. This study aimed to investigate the synergistic antitumor effects of caerin peptides (F1/F3) combined with dendritic cell (DC) vaccines in a 4T-1 murine breast cancer model, providing new insights for breast cancer immunotherapy. <b>Methods</b>: In vitro experiments evaluated the effects of F1/F3 on 4T-1 cell proliferation and apoptosis. A 4T-1 breast cancer mouse model was established, and treatments included F1/F3 alone, DC vaccines (DCV₁: loaded with whole tumor antigens; DCV₂: loaded with F1/F3-induced apoptotic antigens), or combination therapy. Flow cytometry analyzed immune cell subsets in the tumor microenvironment and lymph nodes, while ELISA measured cytokine levels. <b>Results</b>: F1/F3 significantly inhibited 4T-1 cell proliferation and induced apoptosis while suppressing tumor growth and lung metastasis in vivo. Flow cytometry revealed increased infiltration of CD4⁺ T cells and cDC₁ in tumors, along with reduced PD-L1 expression. DCV₂ exhibited stronger T-cell proliferation induction and lower IL-10 secretion in vitro. Combination therapy with DCV₂ and F1/F3 demonstrated superior tumor suppression compared to monotherapy. <b>Conclusions</b>: F1/F3 enhances antitumor immunity by modulating the tumor microenvironment, and its combination with DCV₂ yields synergistic effects. This study provides experimental evidence for combination immunotherapy in breast cancer, with potential for further optimization of DC vaccine design to improve efficacy.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508558","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":"Comprehensive Assessment of Reactogenicity and Safety of the Live-Attenuated Chikungunya Vaccine (IXCHIQ^®).","authors":"Gabriele Maurer, Vera Buerger, Julian Larcher-Senn, Florian Erlsbacher, Stéphanie Meyer, Susanne Eder-Lingelbach, Juan Carlos Jaramillo","doi":"10.3390/vaccines13060576","DOIUrl":"10.3390/vaccines13060576","url":null,"abstract":"<p><p><b>Background/Objectives:</b> This overview provides a comprehensive safety evaluation of the approved live-attenuated vaccine VLA1553 (IXCHIQ^®) for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in clinical trials. <b>Methods</b>: Protocol-defined solicited systemic events (i.e., fever, arthralgia, myalgia, fatigue, and headache) and other unsolicited arthralgia-related events were evaluated. Additionally, during a regulatory review, a broader definition of adverse events of special interest (broad-definition AESIs) (fever and ≥1 AESI symptom within 30 days post-vaccination) was evaluated post hoc. <b>Results</b>: The most frequently reported solicited systemic events post-VLA1553 included fever (13.5%), arthralgia (17.2%), myalgia (23.9%), fatigue (28.5%), and headache (31.6%), with very few prolonged symptoms. The incidence of unsolicited arthralgia-related events (arthritis, osteoarthritis, musculoskeletal stiffness, joint stiffness, and joint swelling) was comparable between VLA1553 and placebo groups. Broad-definition AESIs were observed in 11.7% (361/3082) participants (VLA1553) and 0.6% (6/1033) participants (placebo), with a duration of 1-182 days (median: 4 days; prolonged broad-definition AESI [≥1 symptom lasting ≥ 30 days] occurred in 0.5% of participants) (VLA1553) and 4-27 days (median: 8 days) (placebo). Most symptoms contributing to broad-definition AESIs were solicited. In the VLA1553 group, the most common of these symptoms, in addition to fever, were headache (9.1% of participants), fatigue (8.6%), myalgia (7.0%), and arthralgia (5.2%). There were few severe cases (1.6% of participants in the VLA1553 group). <b>Conclusions</b>: In clinical trials, VLA1553 showed an acceptable safety profile that was consistent with other live-attenuated vaccines. The incidence of broad-definition AESIs was mainly limited to the immediate post-vaccination period, and broad-definition AESI symptoms were mostly solicited systemic adverse events.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508488","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":"The Impact of Bacillus Calmette-Guérin Vaccination and <i>Mycobacterium bovis</i> Infection on Diagnostic Antibody Tests for Mycobacterial Infections.","authors":"Thomas Holder, Nick Robinson, Gareth J Jones","doi":"10.3390/vaccines13060578","DOIUrl":"10.3390/vaccines13060578","url":null,"abstract":"<p><strong>Background: </strong>Bovine tuberculosis (bTB) is an infectious disease which causes significant damage to the farming industry and remains a disease of global significance. Although control strategies have focused on a test and cull approach primarily based around specific cell-mediated immune responses, serological assays are increasingly being used as a supplementary test alongside skin testing and interferon-gamma release (IGRA) assays. The UK is moving towards the use of the Bacillus Calmette-Guérin (BCG) vaccination of cattle as an additional targeted control tool against bTB. However, there are concerns over its potential impact on the outcomes of bTB diagnostic tests and other non-TB assays, such as serological tests for <i>Mycobacterium avium</i> subsp. <i>paratuberculosis</i> (MAP).</p><p><strong>Methods: </strong>We investigated the performance of commercially available serology tests designed to detect bTB and MAP using serum samples from BCG-vaccinated animals which were subsequently infected with <i>Mycobacterium bovis</i> (<i>M. bovis</i>).</p><p><strong>Results: </strong>BCG vaccination per se did not significantly impact the specificity of serological diagnostic tests for bTB or Johne's disease. However, increased numbers of false-positive responses in bTB serology tests were seen in BCG-vaccinated animals 3 weeks following a tuberculin skin test, where up to 23% and 54% of animals gave a positive result in IDEXX and Enferplex tests, respectively. Furthermore, <i>M. bovis</i> infection gave rise to false-positive test results for Johne's disease, irrespective of the animals' prior BCG vaccination status.</p><p><strong>Conclusions: </strong>Caution should be taken when assessing results from serology tests for bTB if tuberculin skin testing has occurred shortly before collection of blood from BCG-vaccinated cattle. Furthermore, these results highlight the potential for misdiagnosis of MAP infection when using serology tests in bTB-infected cattle.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508572","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, Tolerability, and Immunogenicity of a DNA Vaccine (pGX9501) Against SARS-CoV-2 in Healthy Volunteers: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, and Dose-Ranging Phase I Trial.","authors":"Haijing Yang, Yang Zhou, Xin Cheng, Chao Qiu, Shuo Wang, Yu Xia, Xuefen Huai, Zhenning Xiu, Jiarong Wang, Yue He, Guoying Cao, Qiong Wei, Jingjing Wang, Jingwen Ai, Haochen Zhang, Yi Zhang, Jing Zhang, Wenhong Zhang, Bin Wang","doi":"10.3390/vaccines13060573","DOIUrl":"10.3390/vaccines13060573","url":null,"abstract":"<p><p><b>Background</b>: pGX9501 is a prophylactic DNA vaccine encoding the spike protein of SARS-CoV-2 and can induce immune response in the human body so as to prevent COVID-19. With respect to non-clinical studies, pGX9501 has been demonstrated to induce both cellular and humoral immune responses in various animal models. It was found that the level of antibody titers following a two-dose regimen was higher than that following a single-dose regimen in nonhuman primate challenge model. <b>Methods</b>: In China, a phase I, randomized, double-blind, placebo-controlled clinical trial has been conducted in Huashan Hospital, Shanghai, China to evaluate the safety, tolerability, and immunogenicity of DNA vaccine pGX9501 administered intradermally (ID) followed by electroporation (EP) in 45 Chinese healthy volunteers aged 18 to 59 years old. <b>Results</b>: No adverse events of special interest (AESIs), death, or treatment-related SAEs occurred in this study. All the treatment-related (vaccine or EP) adverse events (TRAEs) were of grade 1 and 2 in severity. The solicited AEs were reported in thirty-two (32/36, 88.9%) and nine (9/9, 100.0%) subjects, respectively, in the DNA vaccine and placebo group. The frequency of solicited AEs did not increase with vaccine dose level and frequency. The DNA vaccine pGX9501 effectively enhanced both humoral and cellular immune responses in a dose-dependent manner, with increased antibody GMTs and peak seroconversion rates observed on day 42. The significant rise in IFN-γ levels confirmed the vaccine's ability to induce cellular immune responses. Variations in the microbiome structure suggested a tangible impact of the gut microbiota on vaccine immunogenicity. <b>Conclusions</b>: The findings from this study confirm the immunogenicity and safety of the DNA vaccine pGX9501 and point to the potential role of the gut microbiota in vaccine immune responses. These insights provide practical references for the future design and development of DNA vaccines.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508526","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":"Construction and Preclinical Evaluation of a Recombinant Attenuated Measles Vaccine Candidate of the H1a Genotype.","authors":"Lixia Xie, Yuanbao Liu, Yajing Zhang, Biao Niu, Hui Wang, Yue Guo, Jinliang Wang, Juncheng Ruan, Guandong Xie, Zhiguo Wang, Zhenfang Fu, Qi An, Dayong Tian","doi":"10.3390/vaccines13060571","DOIUrl":"10.3390/vaccines13060571","url":null,"abstract":"<p><p><b>Background</b>: Measles, an acute respiratory infectious disease caused by the measles virus, continues to pose a significant threat to children under five years old worldwide. Despite the availability of effective vaccines, challenges such as insufficient vaccination coverage and antigenic drift contribute to its persistence. Based on a newly isolated wild-type measles virus strain (genotype H1a), designated MVs/Jiangsu.CHN/38.16/1[H1a] (MV-1), this study aims to develop and evaluate a novel recombinant measles virus vaccine candidate designed to enhance immunogenicity and broaden protection against multiple epidemic genotypes. <b>Methods</b>: A recombinant measles virus vaccine candidate, designated rSchwarz/FH(H1a), was developed by incorporating immunogenic genes from the H1a genotype into the backbone of the Schwarz vaccine strain. The genetic stability, safety, and immunogenicity of this vaccine candidate were evaluated in preclinical models. Relevant sample sizes and methodologies were selected to ensure comprehensive assessment of vaccine efficacy against various genotypes (H1a, B3, D8). <b>Results</b>: The rSchwarz/FH(H1a) vaccine candidate demonstrated enhanced immunogenicity, with robust immune responses observed against the targeted genotypes. Additionally, it showed excellent genetic stability and safety profiles, indicating potential for effective use in vaccination programs. Notably, the vaccine provided cross-protection against multiple epidemic genotypes, highlighting its broader application in controlling measles outbreaks. <b>Conclusions</b>: Our findings suggest that the rSchwarz/FH(H1a) vaccine candidate represents a promising advancement in measles vaccine development. It has the potential to strengthen current measles vaccination strategies by providing improved immunogenicity and broader protection against different circulating genotypes. Further clinical trials are warranted to confirm these promising preclinical results.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 6","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12197764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144508489","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}