Human Vaccines & Immunotherapeutics最新文献

{"title":"Absence of autoantibodies linked to cancer and autoimmune disorders 26 weeks after BNT162b2 boosting in CoronaVac- primed individuals.","authors":"Aini Syahida Mat Yassim, Anis Atifah Mohd Hisham, Bushra Solehah Mohd Rosdan, Ti-Myen Tan, Nur Diana Anuar, Ezzeddin Kamil Mohamed Hashim, Mohd Nor Norazmi","doi":"10.1080/21645515.2026.2661499","DOIUrl":"10.1080/21645515.2026.2661499","url":null,"abstract":"<p><p>Concerns regarding vaccine-associated autoimmunity and activation of cancer-related pathways persist, yet longitudinal proteome-wide evaluations of heterologous COVID-19 vaccination regimens remain limited. Here, we assessed the stability of the human 'autoantibodyome' in 30 healthy adults receiving a heterologous CoronaVac-BNT162b2 vaccination regimen (inactivated-virus priming followed by an mRNA booster). Paired serum samples collected pre-vaccination and 26 weeks post-booster were analyzed using the i-Ome™ Discovery protein microarray, which measures IgG reactivity against 1,610 native human antigens associated with autoimmune and oncogenic pathways. After quality-control filtering, 534 high-confidence autoantigens were retained for downstream analysis. Across this panel, autoantibody profiles remained highly stable over time. Linear modeling with false discovery rate correction (FDR > 0.05) and receiver operating characteristic analysis (AUC 0.59-0.67) identified no statistically significant changes in autoantibody reactivity. Principal component analysis demonstrated substantial overlap between pre-vaccination and 26-week post-booster samples, indicating that no combinatorial autoantibody signature distinguished the two timepoints. In stratified analyses, mild breakthrough SARS-CoV-2 infection did not promote aberrant autoantibody production. Within the scope of this high-resolution 1,610-antigen platform, these findings provide proteome-wide evidence that heterologous BNT162b2 boosting after CoronaVac priming is not associated with sustained induction of IgG autoantibodies linked to autoimmune or cancer-related pathways. These findings provide proteome-wide safety evidence supporting the immunological stability of the circulating autoantibody repertoire following mixed-platform COVID-19 vaccination in healthy adults.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2661499"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13170387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876319","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}

{"title":"Global burden of varicella in children aged 5-9 y, relationship with vaccination policy indicators, and projected trends to 2030.","authors":"Zitai Zeng, Xiaosong Ma, Huadong Zhang, Dongmei Yuan, Yunjia Cao, Yang Liu, Jingfu Qiu, Chunbei Zhou","doi":"10.1080/21645515.2026.2726107","DOIUrl":"10.1080/21645515.2026.2726107","url":null,"abstract":"<p><p>Varicella remains a common childhood infection worldwide. Understanding long-term trends and identifying key determinants of disease burden are essential for informing vaccination strategies and public health planning. Data were obtained from the Global Burden of Disease (GBD) 2021 study and the global varicella vaccination policy information. Extreme Gradient Boosting (XGBoost) model was trained to predict the disease burden for 2030. This model estimated the incidence, prevalence, and disability-adjusted life years (DALYs) for varicella among children aged 5-9 y worldwide. Shapley Additive exPlanations (SHAP) was employed to identify key factors and inform public health strategies. From 1990 to 2021, the rate of global incidence rose from 1,028.46/100,000 to 1,048.24/100,000, prevalence from 30.81/100,000 to 31.07/100,000, and DALYs declined from 21.09/100,000 to 12.36/100,000. By 2030, these metrics are projected to fall to 897.01/100,000, 28.96/100,000, and 11.71/100,000, respectively. From 1990 through 2030, Southeast and South Asia had the highest varicella incidence, Asian and Pacific Island nations had the highest prevalence, and sub-Saharan Africa and South Asia had the highest DALYs. SHAP identified population as the strongest predictor (mean absolute SHAP value: 0.167 for incidence and 0.103 for prevalence), and higher vaccination program tier may be associated with lower DALYs. Varicella burden among children aged 5-9 y has declined globally, but model projections indicate that regional disparities will persist. The lack of vaccination coverage and cohort-level immunization data limits interpretation of vaccine effects; future studies should incorporate both coverage and cohort exposure information to strengthen policy evaluation.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2726107"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540090/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148876378","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}

{"title":"Development of a pandemic H5N1 influenza vaccine using MDCK suspension cells: A scalable and efficient production platform.","authors":"Shaobo Zhang, Meihao Wang, Dongwu Jin, Jiayou Zhang, Jiamin Wang, Zhongren Ma, Jinliang Yang","doi":"10.1080/21645515.2026.2679784","DOIUrl":"10.1080/21645515.2026.2679784","url":null,"abstract":"<p><p>The persistent threat of H5N1 avian influenza pandemics necessitates the development of rapid and scalable vaccine manufacturing platforms as alternatives to traditional egg-based systems. We established a complete process for manufacturing an inactivated H5N1 vaccine using serum-free MDCK suspension cells, incorporating cell-line screening, systematic optimization of infection parameters, and scale-up in a bioreactor. High-titer virus propagation (1:1024 HA titer; 10.07 log₁₀CCID₅₀/mL) was achieved in a 75 L bioreactor within 48 h. A purification process employing ultrafiltration and two-step chromatography effectively reduced host cell protein and DNA to 2.20 µg/mL and 3.92 ng/mL, respectively. In a preliminary immunogenicity assessment, two immunizations with a 15 µg dose induced 100% seroconversion (geometric mean titer GMT = 183). This work demonstrates a scalable and efficient cell-based production platform for generating high-quality H5N1 vaccines, offering a promising strategy for pandemic preparedness.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2679784"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248904/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148206588","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}

{"title":"Safety evaluation of inactivated poliomyelitis vaccine.","authors":"Deng Yan, Leng Yunji, Liu Jiawei, Li Jiarong, Lu Junyan, Huang Pinyi, Yang Yufan, Zhou Jianxin, Zhong Zhilei, Yang Jingsi","doi":"10.1080/21645515.2026.2620273","DOIUrl":"10.1080/21645515.2026.2620273","url":null,"abstract":"<p><p>This study aimed to evaluate the safety profile of inactivated poliomyelitis vaccine made from Sabin strains (sIPV) developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, during its post-marketing real-world use in China from 2015 to 2025. A database-based retrospective analysis was conducted using multi-source data, including the Chinese Center for Disease Control and Prevention's (CDC) Adverse Events Following Immunization (AEFI) surveillance system, post-marketing safety studies, and internal vaccination databases. Safety metrics were compared with national IPV (2018-2022) and all marketed vaccines. Statistical analyses employed chi-square and Fisher's exact tests. Among 50,111,746 sIPV doses administered, 12,788 AEFI cases were reported (25.52 per 100,000 doses). sIPV exhibited significantly lower AEFI reported incidences than national IPV data for pyrexia (≥38.6°C) (6.19 vs. 8.51 per 100,000 doses, <i>P</i> < .001), vaccination site erythema/swelling (>2.5 cm) (3.46 vs. 3.85 per 100,000 doses, <i>P</i> < .001), and vaccination site induration (>2.5 cm) (0.90 vs. 1.19 per 100,000 doses, <i>P</i> < .001). The incidence of severe AEFI (0.13 per 100,000 doses) was significantly different (<i>P</i> < .001) from that of the national IPV. Most AEFI (97.41%) occurred within 3 d post-vaccination, and 71.31% resolved completely. sIPV demonstrates an excellent safety profile, supporting its role in polio eradication. Continued monitoring is essential for rare events and regional disparities.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2620273"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12893682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146151166","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}

{"title":"Targeting a conserved flagellin D1 epitope with 16G10 confers cross-serotype protection in murine <i>Pseudomonas aeruginosa</i> infection models.","authors":"Ying Wang, Yating Wang, Zifan Zhu, Qian Wang, Xinglong Liu, Qingli Cai, Yueyue Zhang, Yuhang Li, Hui Zhao, Xin Cheng, Jiang Gu, Quanming Zou, Jianxin Jiang","doi":"10.1080/21645515.2026.2689214","DOIUrl":"10.1080/21645515.2026.2689214","url":null,"abstract":"<p><p>Escalating resistance in <i>Pseudomonas aeruginosa</i> (PA) underscores the need for resistance-agnostic immunotherapies. In this study, we generated a panel of 20 monoclonal antibodies against the flagellin protein FliC and identified 16G10 as a high-affinity lead. Epitope mapping revealed a conserved linear site within the D1 domain (Gly71-Ile88), a region essential for filament assembly. In vitro, 16G10 induced bacterial aggregation, suppressed swimming motility, and significantly reduced adhesion to and invasion of A549 cells, while limiting biofilm biomass by SEM and confocal 3D imaging. <i>In vivo</i>, in murine pneumonia, where 16G10 administered either after pre-incubation with imipenem-resistant PA strain or as post-infection therapy, it improved survival, lowered lung bacterial loads, reduced IL-6 and TNF-α concentrations, and attenuated histologic inflammation. Protection extended across serotype A and B flagellated strains, indicating broad coverage. These data nominate 16G10 as a promising candidate for immunotherapy of drug-resistant PA lung infections and establish a druggable flagellin epitope for future vaccine and antibody designs.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2689214"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148334025","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}

{"title":"HPV vaccination scenario and parental willingness to pay among girls aged 9-14 y in the Yangtze River Delta, China.","authors":"Xiaoya Fu, Qian Zhang, Jia Lu, Lianqin Shi, Yihan Lu","doi":"10.1080/21645515.2026.2681241","DOIUrl":"10.1080/21645515.2026.2681241","url":null,"abstract":"<p><p>Human papillomavirus (HPV) vaccine uptake remains suboptimal among adolescent girls in China. In November 2025, bivalent HPV vaccine was included in China's National Immunization Program for girls aged 13. This study examined girls' vaccination scenario and parental willingness to pay (WTP) for HPV vaccine. A cross-sectional survey was conducted among parents of girls aged 9-14 in the Yangtze River Delta, one of the socioeconomically developed regions in China, between March and August 2025. The survey investigated HPV vaccination scenarios among mothers and their daughters. Contingent valuation method was used to estimate parental WTP. A total of 4,595 parents participated. Overall, 62.6% intended to vaccinate their daughters (39.9% for themselves or their wives), and 8.1% had completed/scheduled HPV vaccination in daughters (35.5% in mothers). It remained inconsistent between mothers and daughters (Kappa = 0.38). Daughters receiving influenza vaccine, parents being informed through schools or community health centers, and greater HPV knowledge were associated with both HPV vaccine intent and uptake (each <i>P</i> < .05). HPV vaccine uptake in daughters was associated with parents endorsing teacher engagement (<i>P</i> = .004). The average WTP was CNY 2,373 for daughters; it was higher among higher-income parents and those with daughters who received influenza vaccine, but lower among parents expecting governmental funding or unwilling to vaccinate daughters (each <i>P</i> < .05). School-based settings are key drivers of HPV vaccine intent and uptake among girls in the Yangtze River Delta. Multi-channel communication and stakeholder engagement may enhance parental decision-making. Improving vaccine financing strategies may promote health equity as China expands HPV vaccination.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2681241"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13232873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148152030","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}

{"title":"Heterogeneity in the psychological antecedents of influenza vaccination among Chinese older adults: A 5C model approach.","authors":"Yuxing Wang, Jianing Dai, Yuanruo Xie, Shuai Yuan, Lili You","doi":"10.1080/21645515.2026.2616903","DOIUrl":"10.1080/21645515.2026.2616903","url":null,"abstract":"<p><p>Seasonal influenza remains a significant public health concern among older adults, who face an increased risk of hospitalization and mortality. Despite the availability of free vaccination programs in many regions of China, influenza vaccination coverage among older adults remains low. Psychological antecedents play a crucial role in shaping vaccination decisions, yet few studies have explored how these factors interact with sociodemographic characteristics. A cross-sectional survey was conducted among 13,363 community-dwelling adults aged ≥60 y in six major Chinese cities between December 2024 and January 2025. The 5C scale - Confidence, Collective Responsibility, Complacency, Constraints, and Calculation - was used to assess psychological determinants of influenza vaccination. Logistic regression models, likelihood ratio tests (LRTs), and stratified analyses were performed to examine the main and interaction effects between psychological and sociodemographic factors. Overall, 34.05% of participants reported receiving an influenza vaccine within the past year. Calculation was positively associated with vaccination uptake (OR = 1.075, 95% CI: 1.057-1.093), while Complacency (OR = 0.658, 95% CI: 0.643-0.673) and Constraints (OR = 0.849, 95% CI: 0.831-0.867) were negatively associated. Significant interaction effects were observed between 5C subscales and education, income, and self-care ability, indicating that the influence of psychological factors varied across subpopulations. The psychological drivers of influenza vaccination among Chinese older adults are heterogeneous across sociodemographic groups. Precision public health strategies are essential: while high-SES individuals may benefit from data-driven information, low-income and low-literacy groups require simplified, emotionally resonant communication focused on personal protection rather than broad altruism. Furthermore, interventions should aim to reduce perceived constraints by streamlining vaccination processes and offering personalized risk-benefit assessments for older adults with chronic conditions.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2616903"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146214183","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}

{"title":"Impact of the two-dose varicella vaccination recommendation program and surveillance optimization on epidemiological trends in a megacity in China.","authors":"Yang Liu, Jiangning Xu, Hang Zhang, Jiawei Xu, Yuanyuan Zhang, Qing Wang, Hengqing Ji, Chunbei Zhou, Ning Yao","doi":"10.1080/21645515.2026.2630521","DOIUrl":"10.1080/21645515.2026.2630521","url":null,"abstract":"<p><p>To assess the impact of implementing a two-dose varicella vaccine (VarV) immunization recommendation program on the incidence of varicella in Chongqing, China. Monthly reported varicella cases from 2011 to 2023 were extracted from the National Notifiable Diseases Reporting System (NNDRS), alongside the vaccination records from the Chongqing Immunization Planning Information Management System. The interrupted time series analysis (ITS) was employed to study the epidemiological trends of varicella. The average reported annual incidence of varicella in Chongqing was 69.6 per 100,000 population during 2011-2023, with the highest incidence recorded in 2019 (133.9 per 100,000 population) and the lowest in 2011 (21.3 per 100,000 population). Children aged 5-9 y accounted for 34.5% of the total cases. Second-dose coverage of VarV surged from 4.1% in 2018 to 27.5% in 2023 among children aged 4-6 y. The segmented regression model demonstrated that, following the incorporation of varicella into the surveillance system in 2014, there was an upward long-term trend in the reported varicella incidence (β₃ = 0.118, <i>P</i> < .01). Following the implementation of the two-dose VarV recommendation strategy in January 2019, a significant long-term decline trend was observed (β₅ = -0.209, <i>P</i> < .01). The official inclusion of varicella into the notifiable disease surveillance can improve the detection, reporting, and evaluation of varicella cases in real-world settings. The implementation of a two-dose VarV recommendation strategy, along with increased coverage of the second dose, can effectively reduce the varicella incidence. Maintaining sensitive surveillance and adhering to the two-dose vaccination schedule are crucial for controlling varicella epidemics.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2630521"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146203315","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}

{"title":"A cross-sectional study of vaccination behavior and willingness regarding respiratory disease-related vaccines among the elderly in Beijing, China.","authors":"Jiao Zhang, Pu Liu, Ping Chu, Shuo Zhang, Li Li, Xiaojing Guo, Shuming Li, Jianxin Ma, Zhen Li, Yunhua Bai, Bin Jia","doi":"10.1080/21645515.2026.2646019","DOIUrl":"10.1080/21645515.2026.2646019","url":null,"abstract":"<p><p>This study aimed to determine the coverage of the 23-valent pneumococcal polysaccharide vaccine (PPV23) and the influenza vaccine, along with related factors, among elderly individuals aged 60 y and above in the capital urban of China. In 2023, 14 out of 43 streets or townships in Chaoyang District were selected using a random sampling method. Elderly participants completed a questionnaire. Logistic regression analysis was employed to identify influencing factors. Among 1,422 respondents, 235 (16.53%) had received the PPV23 vaccine; 747 (52.53%) expressed willingness but had not yet been vaccinated; and 440 (30.94%) indicated unwillingness. Influenza vaccine coverage was higher than that of PPV23: 437 respondents (30.73%) received annual influenza vaccination; 385 (27.07%) were willing but did not consistently receive the vaccine annually; 284 (19.97%) were willing but had not yet been vaccinated; and 316 (22.22%) explicitly refused influenza vaccination. The primary reason for refusal among unwilling participants for both vaccines was the perception that vaccination was unnecessary. For those willing but not ultimately vaccinated, the most frequent reason was lack of awareness regarding available vaccination services. Groups more likely to receive PPV23 and influenza vaccines included individuals who frequently experienced influenza and those recommended by medical staff. These groups also showed a greater inclination to continue influenza vaccination. It is imperative to strengthen community health education on these vaccines, encourage uptake among residents and healthcare professionals, and actively promote the benefits and convenience of PPV23 vaccination.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2646019"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13078232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147677995","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}

{"title":"Adverse reactions following upper arm vs. buttock DTaP vaccination in children: A retrospective observational study in Wuxi, China, 2020-2024.","authors":"Xu Yang, Lingling Wang, Qiujin Chen, Min Yang, Ruixin Shen, Xuwen Wang, Shixin Xiu","doi":"10.1080/21645515.2026.2723634","DOIUrl":"10.1080/21645515.2026.2723634","url":null,"abstract":"<p><p>Adverse reactions are closely associated with vaccination sites, making site selection vital for clinical administration of the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine. This retrospective observational study enrolled 636,169 DTaP inoculations in Wuxi from 2020 to 2024. Adverse reaction data were extracted from the National Adverse Events Following Immunization Surveillance System of China, and dose data were obtained from the Jiangsu Province Vaccination Integrated Service Management Information System. We compared adverse reaction reporting rates stratified by overall incidence, severity, vaccine dose, and clinical manifestations, as well as constituent proportions of adverse reactions according to onset time between upper arm and buttock injection groups. The upper arm group had slightly higher reporting rates of adverse reactions and common reactions than the buttock group, at 23.88 (95% CI: 22.54-25.22) vs. 17.89 (95% CI: 15.56-20.21) and 23.13 (95% CI: 21.81-24.45) vs. 16.94 (95% CI: 14.68-19.20) per 10,000 doses, both <i>p</i> < .001, while rare reaction rates were comparable, at 0.75 (95% CI: 0.51-0.98) vs. 0.95 (95% CI: 0.41-1.48) per 10,000 doses, <i>p</i> = .473. Slightly elevated adverse reaction rates were also found in upper arm administration for the first and second doses. Redness and swelling, induration, and fever were the predominant adverse symptoms, all showing modestly elevated rates after upper arm injection. The adverse reactions at both sites were predominantly common reactions within expected range. Despite a slightly elevated risk of common reactions, upper arm injection may be the preferred site for DTaP vaccination for overall safety.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2723634"},"PeriodicalIF":4.2,"publicationDate":"2026-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13532012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851846","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}