Pub Date : 2025-12-01Epub Date: 2025-01-14DOI: 10.1080/21645515.2025.2450858
Dania Comparcini, Giancarlo Cicolini, Melania Totaro, Letizia Governatori, Francesco Pastore, Daniela Miniscalco, Maria Elena Flacco, Eustachio Cuscianna, Silvio Tafuri, Valentina Simonetti
Achieving safe influenza vaccination coverage among pregnant and breastfeeding women is a global health goal due to the potential risks of serious influenza for both mother and child. However, vaccine hesitancy remains a significant barrier to vaccination uptake. Since anxiety represents a determinant in vaccine decision-making, this study aimed to assess influenza vaccination hesitancy and anxiety levels in this population and to explore the association between women's characteristics, their reluctance, and anxiety levels. A multicentre, cross-sectional study was conducted between February and June 2022 using structured phone interviews to assess: (1) socio-demographics and clinical history; (2) anti-flu vaccination status, previous anti-flu vaccination, and Sars-CoV-2 infection history; (3) insights into influenza vaccination during pregnancy; (4) attitudes toward anti-flu vaccination, using the Vaccination Attitudes Examination (VAX) Scale; (5) anxiety levels, measured by the Self-Rating Anxiety Scale (SAS). Among the 387 participants, 22.8% were already vaccinated or expressed willingness to be vaccinated against influenza, and 54% had an anxiety disorder. While anxiety was not significantly associated with vaccine hesitancy, ongoing pregnancy emerged as an independent predictor of anxiety. Higher educational levels, ongoing pregnancy, already being vaccinated or willingness to get vaccinated, and being employed were associated with reduced vaccine hesitancy, while prior SARS-CoV-2 infection with increased hesitancy. Fear of unpredictable events and lack of healthcare professionals' recommendations emerged as reasons for vaccine reluctance. Given the low coverage rates, these findings highlight the need for health services to enhance vaccination efforts and provide clear recommendations to counter misinformation and ensure accurate vaccine safety information.
{"title":"Influenza vaccination hesitancy and related factors among pregnant and breastfeeding women: A cross-sectional study.","authors":"Dania Comparcini, Giancarlo Cicolini, Melania Totaro, Letizia Governatori, Francesco Pastore, Daniela Miniscalco, Maria Elena Flacco, Eustachio Cuscianna, Silvio Tafuri, Valentina Simonetti","doi":"10.1080/21645515.2025.2450858","DOIUrl":"10.1080/21645515.2025.2450858","url":null,"abstract":"<p><p>Achieving safe influenza vaccination coverage among pregnant and breastfeeding women is a global health goal due to the potential risks of serious influenza for both mother and child. However, vaccine hesitancy remains a significant barrier to vaccination uptake. Since anxiety represents a determinant in vaccine decision-making, this study aimed to assess influenza vaccination hesitancy and anxiety levels in this population and to explore the association between women's characteristics, their reluctance, and anxiety levels. A multicentre, cross-sectional study was conducted between February and June 2022 using structured phone interviews to assess: (1) socio-demographics and clinical history; (2) anti-flu vaccination status, previous anti-flu vaccination, and Sars-CoV-2 infection history; (3) insights into influenza vaccination during pregnancy; (4) attitudes toward anti-flu vaccination, using the Vaccination Attitudes Examination (VAX) Scale; (5) anxiety levels, measured by the Self-Rating Anxiety Scale (SAS). Among the 387 participants, 22.8% were already vaccinated or expressed willingness to be vaccinated against influenza, and 54% had an anxiety disorder. While anxiety was not significantly associated with vaccine hesitancy, ongoing pregnancy emerged as an independent predictor of anxiety. Higher educational levels, ongoing pregnancy, already being vaccinated or willingness to get vaccinated, and being employed were associated with reduced vaccine hesitancy, while prior SARS-CoV-2 infection with increased hesitancy. Fear of unpredictable events and lack of healthcare professionals' recommendations emerged as reasons for vaccine reluctance. Given the low coverage rates, these findings highlight the need for health services to enhance vaccination efforts and provide clear recommendations to counter misinformation and ensure accurate vaccine safety information.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2450858"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2024-12-22DOI: 10.1080/21645515.2024.2440956
Rui Zhang, Ngai Sze Wong, Sze Long Chung, Chi Keung Kwan, Tsz Ho Kwan, Shui Shan Lee
Human papillomavirus (HPV) vaccination could reduce HPV infection in men who have sex with men (MSM), but the published statistics on HPV vaccination uptake in MSM were scarce globally. This study estimated the uptake and profiled the service preferences of HPV vaccination of Chinese MSM in Hong Kong. Adult MSM were recruited through non-governmental organizations (NGOs) and online channels for completing an online baseline survey. Factors associated with self-reported history of HPV vaccination were identified using multivariable stepwise logistic regression model. Totally 701 Chinese MSM completed the online baseline survey, with the median age of 30 y (interquartile range [IQR] 26-35, range 18-67), and 23% of them had received HPV vaccination. More than half of vaccinated MSM (72%) rated convenient or very convenient for local HPV vaccination services. Among unvaccinated MSM, 50% considered high cost of HPV vaccine as the barrier of vaccination, 67% expressed willingness to pay below USD 128 per vaccine dose, and 65% preferred receiving vaccination in private clinics. MSM who had taken HIV pre-exposure prophylaxis (PrEP) (p < .001), had been tested for HPV (p = .018), and had (p = .005) multiple regular sex partners in the past 6 months were more likely to be vaccinated. The HPV vaccination uptake of Chinese MSM in Hong Kong remains low (23%), and high HPV vaccine cost is the main barrier. Preventive behaviors (HIV PrEP use and HPV testing) and high-risk sexual behavior (multiple regular sex partners) are potential targets for intervention to increase the uptake of HPV vaccination in MSM.
{"title":"Uptake and service preferences of human papillomavirus vaccination in men who have sex with men.","authors":"Rui Zhang, Ngai Sze Wong, Sze Long Chung, Chi Keung Kwan, Tsz Ho Kwan, Shui Shan Lee","doi":"10.1080/21645515.2024.2440956","DOIUrl":"https://doi.org/10.1080/21645515.2024.2440956","url":null,"abstract":"<p><p>Human papillomavirus (HPV) vaccination could reduce HPV infection in men who have sex with men (MSM), but the published statistics on HPV vaccination uptake in MSM were scarce globally. This study estimated the uptake and profiled the service preferences of HPV vaccination of Chinese MSM in Hong Kong. Adult MSM were recruited through non-governmental organizations (NGOs) and online channels for completing an online baseline survey. Factors associated with self-reported history of HPV vaccination were identified using multivariable stepwise logistic regression model. Totally 701 Chinese MSM completed the online baseline survey, with the median age of 30 y (interquartile range [IQR] 26-35, range 18-67), and 23% of them had received HPV vaccination. More than half of vaccinated MSM (72%) rated convenient or very convenient for local HPV vaccination services. Among unvaccinated MSM, 50% considered high cost of HPV vaccine as the barrier of vaccination, 67% expressed willingness to pay below USD 128 per vaccine dose, and 65% preferred receiving vaccination in private clinics. MSM who had taken HIV pre-exposure prophylaxis (PrEP) (<i>p</i> < .001), had been tested for HPV (<i>p</i> = .018), and had (<i>p</i> = .005) multiple regular sex partners in the past 6 months were more likely to be vaccinated. The HPV vaccination uptake of Chinese MSM in Hong Kong remains low (23%), and high HPV vaccine cost is the main barrier. Preventive behaviors (HIV PrEP use and HPV testing) and high-risk sexual behavior (multiple regular sex partners) are potential targets for intervention to increase the uptake of HPV vaccination in MSM.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2440956"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2024-12-20DOI: 10.1080/21645515.2024.2435156
Hao Lei, Beidi Niu, Zhou Sun, Yaojing Wang, Xinren Che, Shengqiang Du, Yan Liu, Ke Zhang, Shi Zhao, Shigui Yang, Zhe Wang, Gang Zhao
From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024. The VE was estimated using multivariate logistic regression models adjusted for sex, age, influenza detection methods, and influenza testing timing. Of the 157,291 medically-attended ILI participants enrolled 56,704 (36%) tested positive for influenza. Adjusted overall VE against any medically-attended influenza infection was 48% (95% Confidence interval [CI]: 46%-51%). The overall VE of the trivalent inactivated influenza vaccine (IIV3) was 59% (95% CI: 50%-66%), followed by the trivalent live attenuated vaccine (LAIV3) (VE = 53%, 95% CI: 42%-62%) and quadrivalent inactivated influenza vaccine (IIV4) (VE = 47%, 95% CI: 45%-50%). IIV3 provided even better protection against medically-attended influenza B infection than IIV4 (VE = 87%, 95% CI: 81%-92% for IIV3 versus VE = 53%, 95% CI: 50%-57% for IIV4). In the 2023/24 season in Hangzhou, China, the influenza vaccine offered moderate protection during a major epidemic. The results supported the World Health Organization recommendation to exclude the B/Yamagata lineage antigen in quadrivalent influenza vaccines in 2023.
{"title":"Influenza vaccine effectiveness against medically-attended influenza infection in 2023/24 season in Hangzhou, China.","authors":"Hao Lei, Beidi Niu, Zhou Sun, Yaojing Wang, Xinren Che, Shengqiang Du, Yan Liu, Ke Zhang, Shi Zhao, Shigui Yang, Zhe Wang, Gang Zhao","doi":"10.1080/21645515.2024.2435156","DOIUrl":"https://doi.org/10.1080/21645515.2024.2435156","url":null,"abstract":"<p><p>From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024. The VE was estimated using multivariate logistic regression models adjusted for sex, age, influenza detection methods, and influenza testing timing. Of the 157,291 medically-attended ILI participants enrolled 56,704 (36%) tested positive for influenza. Adjusted overall VE against any medically-attended influenza infection was 48% (95% Confidence interval [CI]: 46%-51%). The overall VE of the trivalent inactivated influenza vaccine (IIV3) was 59% (95% CI: 50%-66%), followed by the trivalent live attenuated vaccine (LAIV3) (VE = 53%, 95% CI: 42%-62%) and quadrivalent inactivated influenza vaccine (IIV4) (VE = 47%, 95% CI: 45%-50%). IIV3 provided even better protection against medically-attended influenza B infection than IIV4 (VE = 87%, 95% CI: 81%-92% for IIV3 versus VE = 53%, 95% CI: 50%-57% for IIV4). In the 2023/24 season in Hangzhou, China, the influenza vaccine offered moderate protection during a major epidemic. The results supported the World Health Organization recommendation to exclude the B/Yamagata lineage antigen in quadrivalent influenza vaccines in 2023.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2435156"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-01-06DOI: 10.1080/21645515.2024.2444697
Fang-Ju Huang, Ye-Ying Fang, Jia-Ying Wen, Jian-Jun Li, Qian Lin, Qin-Yan Su, Yi-Yang Chen, Lei Wang, Jian-Jia Zeng, Bang-Teng Chi, Rong-Quan He, Di-Yuan Qin, Li-Hua Yang, Gang Chen
Cholangiocarcinoma (CCA) is a highly malignant hepatobiliary tumor characterized by limited treatment options and poor prognosis. The recent rise of immunotherapy has significantly influenced research in this field. This study presents a bibliometric analysis of 416 articles retrieved from the WOSCC, Wan fang Data, CNKI and VIP databases, spanning contributions from 32 countries, 589 institutions and 3,200 authors. The analysis identified "PD-L1," "PD-1" and "pembrolizumab" as central research foci, while "immune checkpoint inhibitors," "tumor immune microenvironment," "tertiary lymphoid structures" and "durvalumab" emerged as key areas of interest. These findings emphasize the pivotal role of immunotherapy in improving survival outcomes for CCA, and they highlight the significance of tertiary lymphoid structures within the tumor microenvironment as a promising target for future research. This study offers a strategic overview of the evolving landscape of CCA immunotherapy, providing valuable insights to guide future scientific endeavors in this domain.
{"title":"From PD-1/PD-L1 to tertiary lymphoid structures: Paving the way for precision immunotherapy in cholangiocarcinoma treatment.","authors":"Fang-Ju Huang, Ye-Ying Fang, Jia-Ying Wen, Jian-Jun Li, Qian Lin, Qin-Yan Su, Yi-Yang Chen, Lei Wang, Jian-Jia Zeng, Bang-Teng Chi, Rong-Quan He, Di-Yuan Qin, Li-Hua Yang, Gang Chen","doi":"10.1080/21645515.2024.2444697","DOIUrl":"https://doi.org/10.1080/21645515.2024.2444697","url":null,"abstract":"<p><p>Cholangiocarcinoma (CCA) is a highly malignant hepatobiliary tumor characterized by limited treatment options and poor prognosis. The recent rise of immunotherapy has significantly influenced research in this field. This study presents a bibliometric analysis of 416 articles retrieved from the WOSCC, Wan fang Data, CNKI and VIP databases, spanning contributions from 32 countries, 589 institutions and 3,200 authors. The analysis identified \"PD-L1,\" \"PD-1\" and \"pembrolizumab\" as central research foci, while \"immune checkpoint inhibitors,\" \"tumor immune microenvironment,\" \"tertiary lymphoid structures\" and \"durvalumab\" emerged as key areas of interest. These findings emphasize the pivotal role of immunotherapy in improving survival outcomes for CCA, and they highlight the significance of tertiary lymphoid structures within the tumor microenvironment as a promising target for future research. This study offers a strategic overview of the evolving landscape of CCA immunotherapy, providing valuable insights to guide future scientific endeavors in this domain.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2444697"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142933382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-01-22DOI: 10.1080/21645515.2025.2454078
Ting Zhang, Zhongquan Jian, Juan Chen, Dongzi Xu, Xiaoyi Yang, Yan Lu, Shu Yan, Lizi Pan, Qingqiang Wu, Zhaolian Ouyang
mRNA vaccines offer groundbreaking technological advantages and broad application potential. Their rapid advancement, particularly during the COVID-19 pandemic, is the result of decades of research and numerous technological breakthroughs. These discoveries build upon each other, forming dense, interconnected networks of progress. Studying the technological development paths of mRNA vaccines is therefore essential. Main path analysis (MPA) is particularly effective for mapping out development trajectories within complex and interconnected networks, which serves as a powerful tool for identifying key nodes and innovations. This study introduces a novel approach to extracting main paths from a patent citation network in the mRNA vaccine field. Initially, we shielded edges connecting the origin and terminus patents. Subsequently, we extracted the main paths from intermediate patents, and then, we reintegrated the edges connecting the origin and terminus patents based on the citation relationships, resulting in a comprehensive extraction of the main paths. The research findings indicate a consistency among the global main paths, global key-route main paths, local forward main paths, and local key-route main paths within the mRNA vaccine field. The patents on the main paths predominantly focus on nucleic acid modifications and delivery systems. The local backward main paths identify a greater number of patents, especially those related to litigation, offering a richer and more diverse set of technological insights. This study significantly advances the methodology of MPA, with the innovative shielding technique offering a fresh perspective for navigating complex networks and providing a deeper understanding of technological development in the mRNA vaccine domain.
{"title":"Efficiency enhancement in main path extraction in mRNA vaccine field: A novel approach leveraging intermediate patents, with shielding origin and terminus patent edges.","authors":"Ting Zhang, Zhongquan Jian, Juan Chen, Dongzi Xu, Xiaoyi Yang, Yan Lu, Shu Yan, Lizi Pan, Qingqiang Wu, Zhaolian Ouyang","doi":"10.1080/21645515.2025.2454078","DOIUrl":"https://doi.org/10.1080/21645515.2025.2454078","url":null,"abstract":"<p><p>mRNA vaccines offer groundbreaking technological advantages and broad application potential. Their rapid advancement, particularly during the COVID-19 pandemic, is the result of decades of research and numerous technological breakthroughs. These discoveries build upon each other, forming dense, interconnected networks of progress. Studying the technological development paths of mRNA vaccines is therefore essential. Main path analysis (MPA) is particularly effective for mapping out development trajectories within complex and interconnected networks, which serves as a powerful tool for identifying key nodes and innovations. This study introduces a novel approach to extracting main paths from a patent citation network in the mRNA vaccine field. Initially, we shielded edges connecting the origin and terminus patents. Subsequently, we extracted the main paths from intermediate patents, and then, we reintegrated the edges connecting the origin and terminus patents based on the citation relationships, resulting in a comprehensive extraction of the main paths. The research findings indicate a consistency among the global main paths, global key-route main paths, local forward main paths, and local key-route main paths within the mRNA vaccine field. The patents on the main paths predominantly focus on nucleic acid modifications and delivery systems. The local backward main paths identify a greater number of patents, especially those related to litigation, offering a richer and more diverse set of technological insights. This study significantly advances the methodology of MPA, with the innovative shielding technique offering a fresh perspective for navigating complex networks and providing a deeper understanding of technological development in the mRNA vaccine domain.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2454078"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-01-21DOI: 10.1080/21645515.2024.2436714
Amparo L Figueroa, Kashif Ali, Gary Berman, Wenqin Xu, Weiping Deng, Bethany Girard, Anne Yeakey, Karen Slobod, Jacqueline Miller, Rituparna Das, Frances Priddy
Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2-negative and -positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.
{"title":"Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents.","authors":"Amparo L Figueroa, Kashif Ali, Gary Berman, Wenqin Xu, Weiping Deng, Bethany Girard, Anne Yeakey, Karen Slobod, Jacqueline Miller, Rituparna Das, Frances Priddy","doi":"10.1080/21645515.2024.2436714","DOIUrl":"https://doi.org/10.1080/21645515.2024.2436714","url":null,"abstract":"<p><p>Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2-negative and -positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2436714"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-02-11DOI: 10.1080/21645515.2025.2463191
Ariel Bardach, Martin Brizuela, Mabel Berrueta, Agustín Ciapponi, Juan M Sambade, Jamile Ballivian, Vanesa Ortega, Noelia Castellana, Daniel Comandé, Edward P K Parker, Beate Kampmann, Katharina Stegelmann, Xu Xiong, Andy Stergachis, Flor M Munoz, Pierre Buekens, Agustina Mazzoni
Chikungunya virus (CHIKV), transmitted through Aedes mosquitoes, is a significant global health concern. Various vaccine platforms have been explored to combat CHIKV, including formalin inactivation, live-attenuated strains, virus-like particles (VLPs), viral vectors, and mRNA technologies. This umbrella review synthesizes evidence on the safety profiles of vaccine platforms used in Chikungunya vaccines that have been applied in other vaccines, focusing on adverse events of special interest (AESI) in pregnant persons, children, and adolescents. A comprehensive overview of systematic reviews (SRs) was conducted. Results: Seven systematic reviews were included and complemented with primary studies. Vaccines like influenza, human papillomavirus (HPV), and COVID-19, which share platforms with Chikungunya vaccines, showed no significant increase in AESI. Moderate-to high-quality SRs supported favorable safety profiles. Vaccines sharing platforms with Chikungunya vaccines generally exhibit acceptable safety profiles in pregnant persons, children, and adolescents.
{"title":"Umbrella review of the safety of Chikungunya vaccine platforms used in other vaccines.","authors":"Ariel Bardach, Martin Brizuela, Mabel Berrueta, Agustín Ciapponi, Juan M Sambade, Jamile Ballivian, Vanesa Ortega, Noelia Castellana, Daniel Comandé, Edward P K Parker, Beate Kampmann, Katharina Stegelmann, Xu Xiong, Andy Stergachis, Flor M Munoz, Pierre Buekens, Agustina Mazzoni","doi":"10.1080/21645515.2025.2463191","DOIUrl":"10.1080/21645515.2025.2463191","url":null,"abstract":"<p><p>Chikungunya virus (CHIKV), transmitted through <i>Aedes</i> mosquitoes, is a significant global health concern. Various vaccine platforms have been explored to combat CHIKV, including formalin inactivation, live-attenuated strains, virus-like particles (VLPs), viral vectors, and mRNA technologies. This umbrella review synthesizes evidence on the safety profiles of vaccine platforms used in Chikungunya vaccines that have been applied in other vaccines, focusing on adverse events of special interest (AESI) in pregnant persons, children, and adolescents. A comprehensive overview of systematic reviews (SRs) was conducted. Results: Seven systematic reviews were included and complemented with primary studies. Vaccines like influenza, human papillomavirus (HPV), and COVID-19, which share platforms with Chikungunya vaccines, showed no significant increase in AESI. Moderate-to high-quality SRs supported favorable safety profiles. Vaccines sharing platforms with Chikungunya vaccines generally exhibit acceptable safety profiles in pregnant persons, children, and adolescents.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2463191"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143392190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-02-16DOI: 10.1080/21645515.2025.2465116
Dhriti Jagadish, Nathaniel Mamo, Felicia Pasadyn, Arthur Caplan
Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.
知情同意是医学伦理不可或缺的原则。然而,美国缺乏标准化的免疫接种同意程序,各州和私营公司只能依赖 1986 年《全国儿童疫苗伤害法案》引入的《疫苗信息声明》(VISs)。VISs 的制定并没有考虑到患者的自主权,而是为了应对过多的疫苗伤害诉讼和由此造成的疫苗供应短缺。VISs 并没有提供有意义的信息披露,其制作者--疾病控制和预防中心--自己也承认,VISs 不应被误认为是知情同意书。在内容上,VIS 的可读性过于复杂,没有将免疫接种置于公共卫生的背景下,也没有介绍所有的替代方案。VIS 的提供也不充分,给患者消化疫苗信息的时间有限,而且不需要任何文件来确保 VIS 的提供。简而言之,VIS 对引发深思熟虑和增加对疫苗的信心作用甚微。本文建议对 VIS 的内容、提供和问责机制稍作改进,以确保分发。作者认为,不应该浪费这些病人--提供者的时刻--让病人更好地了解自己的健康、疾病的威胁以及他们对公众所做贡献的分量。
{"title":"Is informed consent correctly obtained for vaccinations?","authors":"Dhriti Jagadish, Nathaniel Mamo, Felicia Pasadyn, Arthur Caplan","doi":"10.1080/21645515.2025.2465116","DOIUrl":"10.1080/21645515.2025.2465116","url":null,"abstract":"<p><p>Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer - the Centers for Disease Control and Prevention - itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments - for patients to better understand their health, the threat of disease, and the weight of their contribution to the public - should not be squandered.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2465116"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-03-13DOI: 10.1080/21645515.2025.2474772
Abby E Rudolph, Nadine Al Akoury, Natalija Bogdanenko, Kristen Markus, Isabelle Whittle, Olivia Wright, Hammam Haridy, Julia R Spinardi, John M McLaughlin, Moe H Kyaw
This systematic literature review summarizes the evidence across 56 publications and pre-prints (January 2020-July 2023) with low-risk of bias based on JBI critical appraisal, that report adjusted estimates for the relationship between COVID-19 vaccination and Post-COVID-19 Condition (PCC) by timing of vaccination relative to infection or PCC-onset. Comparisons of adjusted vaccine effectiveness (aVE) against ≥1 PCC (vs. unvaccinated) across study characteristics known to impact PCC burden or VE against other COVID-19 endpoints were possible for 31 studies where vaccination preceded infection. Seventy-seven percent of pre-infection aVE estimates were statistically significant (range: 7%-95%). Statistically significant pre-infection aVE estimates were slightly higher for mRNA (range: 14%-84%) than non-mRNA vaccines (range: 16%-38%) and aVE ranges before and during Omicron overlapped. Our findings suggest that COVID-19 vaccination before SARS-CoV-2 infection reduces the risk of PCC regardless of vaccine type, number of doses received, PCC definition, predominant variant, and severity of acute infections included.
{"title":"Factors affecting the impact of COVID-19 vaccination on post COVID-19 conditions among adults: A systematic literature review.","authors":"Abby E Rudolph, Nadine Al Akoury, Natalija Bogdanenko, Kristen Markus, Isabelle Whittle, Olivia Wright, Hammam Haridy, Julia R Spinardi, John M McLaughlin, Moe H Kyaw","doi":"10.1080/21645515.2025.2474772","DOIUrl":"10.1080/21645515.2025.2474772","url":null,"abstract":"<p><p>This systematic literature review summarizes the evidence across 56 publications and pre-prints (January 2020-July 2023) with low-risk of bias based on JBI critical appraisal, that report adjusted estimates for the relationship between COVID-19 vaccination and Post-COVID-19 Condition (PCC) by timing of vaccination relative to infection or PCC-onset. Comparisons of adjusted vaccine effectiveness (aVE) against ≥1 PCC (vs. unvaccinated) across study characteristics known to impact PCC burden or VE against other COVID-19 endpoints were possible for 31 studies where vaccination preceded infection. Seventy-seven percent of pre-infection aVE estimates were statistically significant (range: 7%-95%). Statistically significant pre-infection aVE estimates were slightly higher for mRNA (range: 14%-84%) than non-mRNA vaccines (range: 16%-38%) and aVE ranges before and during Omicron overlapped. Our findings suggest that COVID-19 vaccination before SARS-CoV-2 infection reduces the risk of PCC regardless of vaccine type, number of doses received, PCC definition, predominant variant, and severity of acute infections included.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2474772"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11913386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The buildup of senescent cells exacerbates metabolic disorders in adipose tissue and contributes to aging-related cardiac dysfunction. Targeted clearance of senescent cells can markedly ameliorate these aging-related diseases. Here, we developed a novel nanovaccine (GK-NaV) loaded with seno-antigen that is self-assembled from the fusion of cationic protein (K36) and seno-antigen peptide (Gpnmb). The GK-NaV could be highly engulfed by bone marrow-derived dendritic cells (BMDCs) and efficiently present antigens on the cellular surface, thereby promoting DCs maturation and activation of CD8+T cells in vitro. Following subcutaneous immunization, GK-NaV not only exhibited a noticeable antigen depot effect but also markedly activated specific cellular immune responses, enhancing the immunoreactivity and cytotoxic effects of CD8+T cells. Consequently, the targeted anti-aging immunity triggered by GK-NaV demonstrated the ability to selectively eliminate senescent adipocytes and cardiomyocytes in high-fat diet (HFD)-induced progeroid mice, leading to a significant improvement in age-related metabolic disorders in adipose tissue and cardiac dysfunction. Hence, our findings indicate that immunization with GK-NaV targeting seno-antigens may represent a promising strategy for novel senolytic therapies.
{"title":"Nanovaccine loaded with seno-antigen target senescent cells to improve metabolic disorders of adipose tissue and cardiac dysfunction.","authors":"Kexin Zhang, Qiliang Yin, Yucen Ma, Mengyu Cao, Lingwei Li, Xinliang Jin, Jiyan Leng","doi":"10.1080/21645515.2025.2479229","DOIUrl":"10.1080/21645515.2025.2479229","url":null,"abstract":"<p><p>The buildup of senescent cells exacerbates metabolic disorders in adipose tissue and contributes to aging-related cardiac dysfunction. Targeted clearance of senescent cells can markedly ameliorate these aging-related diseases. Here, we developed a novel nanovaccine (GK-NaV) loaded with seno-antigen that is self-assembled from the fusion of cationic protein (K36) and seno-antigen peptide (Gpnmb). The GK-NaV could be highly engulfed by bone marrow-derived dendritic cells (BMDCs) and efficiently present antigens on the cellular surface, thereby promoting DCs maturation and activation of CD8<sup>+</sup>T cells in vitro. Following subcutaneous immunization, GK-NaV not only exhibited a noticeable antigen depot effect but also markedly activated specific cellular immune responses, enhancing the immunoreactivity and cytotoxic effects of CD8<sup>+</sup>T cells. Consequently, the targeted anti-aging immunity triggered by GK-NaV demonstrated the ability to selectively eliminate senescent adipocytes and cardiomyocytes in high-fat diet (HFD)-induced progeroid mice, leading to a significant improvement in age-related metabolic disorders in adipose tissue and cardiac dysfunction. Hence, our findings indicate that immunization with GK-NaV targeting seno-antigens may represent a promising strategy for novel senolytic therapies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2479229"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11916409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}