Human Vaccines & Immunotherapeutics最新文献

{"title":"Immunogenicity and safety of prophylactic HPV vaccines in people living with HIV: A systematic review and meta-analysis.","authors":"Bahar Senel, Gokhan Senel, Ceren Elma","doi":"10.1080/21645515.2026.2724680","DOIUrl":"10.1080/21645515.2026.2724680","url":null,"abstract":"<p><p>Human papillomavirus (HPV) is a major global public health concern, causing genital warts and cancers of the cervix, anus, oropharynx, vulva, and penis. People living with HIV (PLWH) face a disproportionately elevated burden of HPV infection and HPV-related malignancies due to chronic immunosuppression. We conducted a systematic review and meta-analysis searching six databases from January 2006 to June 2026 without language restrictions. Twenty-five studies were included in the systematic review; 12 independent studies (N = 1,493 for HPV16) were included in the quantitative meta-analysis. Using a DerSimonian-Laird random-effects model with logit transformation, pooled seroconversion rates were: HPV16 97.8% (95% CI: 94.9-99.1%; I² = 89.6%; 15 datasets), HPV18 94.2% (95% CI: 86.1-97.7%; I² = 95.8%; 13 datasets), HPV6 97.0% (95% CI: 93.7-98.6%; I² = 66.1%; 10 studies), and HPV11 97.1% (95% CI: 90.5-99.1%; I² = 95.5%; 10 studies). CD4 count was the most consistently reported modifier of immunogenic response: HPV16 seroconversion was 98.5% in PLWH with CD4 > 350 cells/μL vs. 71.1% in those with CD4 ≤ 200 cells/μL (ACTG A5240). All three vaccine generations demonstrated high immunogenicity. Two doses of the nonavalent vaccine were non-inferior to three doses in virologically suppressed women (Papillon RCT). No vaccine-related serious adverse events were reported. GRADE certainty of evidence was moderate for HPV16, HPV6, and HPV11, and low for HPV18. Prophylactic HPV vaccination achieves high seroconversion rates across all vaccine generations in PLWH. CD4 count significantly modifies vaccine response, underscoring the importance of vaccination before severe immunosuppression develops. These findings support current international recommendations advocating HPV vaccination for all PLWH.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2724680"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148882059","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":"Pharmacovigilance signals of dupilumab among pediatric patients: A real‑world analysis based on the FAERS database.","authors":"Xueqing Ma, Jiaojiao Fan, Ben Liu","doi":"10.1080/21645515.2026.2727805","DOIUrl":"10.1080/21645515.2026.2727805","url":null,"abstract":"<p><p>Dupilumab is effective for the treatment of moderate‑to‑severe type 2 inflammatory diseases; however, its real‑world safety profile in pediatric patients remains to be further clarified. This retrospective pharmacovigilance study analyzed U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) data from 2017 to 2025, including 44,593 reports where dupilumab was the primary suspect drug in children. Disproportionality analyses (ROR, PRR, BCPNN, MGPS), time-to-onset analysis, stratified analysis, and Weibull modeling assessed adverse event (AE) distribution and patterns. Results showed balanced sex distribution (male 50.1%, female 48.6%), with adolescents (12-17y) most common (45.3%), and report counts increasing over time. 93 positive safety signals were detected. The most common core AEs were rash (4,105 cases; ROR = 4.55, 95% CI: 4.38-4.72), injection site pain (3,582 cases; ROR = 8.59, 95% CI: 8.22-8.97), and skin exfoliation (1,834 cases; ROR = 3.41, 95% CI: 3.23-3.59). Potential unlisted signals included vitiligo (33 cases; ROR = 10.46, 95% CI: 6.52-16.78), skin depigmentation (32 cases; ROR = 13.04, 95% CI: 7.85-21.66), and eye color change (13 cases; ROR = 7.06, 95% CI: 3.54-14.11). Stratified analyses indicated distinct patterns of adverse‑event reporting across age and sex strata. Among cases with complete temporal information, most AEs occurred within 30d after dupilumab initiation, with a median time‑to‑onset of 14d. In conclusion, this large-scale spontaneous-reporting study detected potential safety signals in children. Given FAERS data limitations, the associations should be viewed as hypothesis-generating rather than confirmatory, and may inform future signal validation and prospective studies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2727805"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13556953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148892694","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":"Predictors of influenza vaccination among Iranian pregnant women based on a combined Health Belief Model and Theory of Planned behavior.","authors":"Masoud Yousefi, Mohammad Ansarizadeh, Farzaneh Ghaleh Golab, Andishe Hamedi, Hossein Lashkardoost, Ali Khani Jeihooni","doi":"10.1080/21645515.2026.2727747","DOIUrl":"10.1080/21645515.2026.2727747","url":null,"abstract":"<p><p>Influenza poses a significant public health risk, particularly for pregnant women due to physiological and immunological changes. Despite strong recommendations and proven safety of influenza vaccination, uptake remains suboptimal. This study aimed to identify predictors of influenza vaccination among Iranian pregnant women using an integrated Health Belief Model (HBM) and Theory of Planned Behavior (TPB). A cross-sectional analytical study was conducted among 630 pregnant women attending urban and rural health centers and private clinics in Fasa and Shiraz, Iran. Participants were selected using multistage stratified sampling. Data were collected by a validated, researcher-developed questionnaire based on HBM and TPB constructs. Statistical analyses included descriptive statistics, Spearman correlation, logistic regression, and Structural Equation Modeling (SEM). The mean age of participants was 29.36y, and 73% received the influenza vaccine during the current pregnancy. The most common barriers were concerns about side effects (49.4%), limited access (28.2%), lack of provider recommendation (27.1%), and insufficient information (34.1%). SEM results indicated that perceived susceptibility (beta = 0.18), perceived barriers (beta = -0.15), and attitude (beta = 0.13) were significant predictors of behavioral intention. Behavioral intention had a small but significant effect on actual vaccination (beta = 0.08). Subjective norms, self-efficacy, and perceived behavioral control were not significant predictors. Perceived susceptibility, common barriers, and attitude play key roles in shaping vaccination intention, while structural factors limit the translation of intention into action. Interventions focusing on education, improving provider-patient communication, and reducing access barriers may enhance vaccination uptake among pregnant women.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2727747"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13556958/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148907851","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":"Ivonescimab combined with chemotherapy for the treatment of metastatic cervical cancer: A case report and literature review.","authors":"Motong Xu, Shuo Qiu, Jie Zhou, Yongchun Zhang","doi":"10.1080/21645515.2026.2632451","DOIUrl":"10.1080/21645515.2026.2632451","url":null,"abstract":"<p><p>The prognosis for patients with recurrent or metastatic cervical cancer (r/mCC) remains challenging, with a 5-y survival rate of approximately 17%. Although first-line treatment has evolved from traditional single-agent chemotherapy to combination regimens that incorporate targeted therapy and immunotherapy-showing improved initial response rates - therapeutic options after disease progression remain limited and often yield suboptimal outcomes. Ivonescimab, the first tetravalent bispecific monoclonal antibody capable of simultaneously targeting programmed death receptor-1 (PD-1) and vascular endothelial growth factor A (VEGF-A), demonstrates robust anti-tumor activity and a manageable safety profile across various solid tumors through synergistic blockade of both immune checkpoint pathways and tumor angiogenesis. This case report describes a patient diagnosed with cervical squamous cell carcinoma accompanied by hepatic metastases who received first-line therapy with platinum-based chemotherapy in combination with cadonilimab and bevacizumab. According to RECIST 1.1 criteria, a partial response (PR) was achieved after four treatment cycles, with a PFS of 11 months. Subsequent to disease progression, second-line treatment was initiated with ivonescimab combined with single-agent albumin-bound paclitaxel. After two treatment cycles, PR was achieved, and the patient continues to derive clinical benefits. Throughout the treatment course, the patient experienced only low-grade adverse events (CTCAE grade 1 or below) and maintained a satisfactory quality of life. To our knowledge, this is the first reported case demonstrating a significant response to ivonescimab in recurrent or metastatic cervical cancer following failure of first-line immunotherapy combined with anti-angiogenic therapy. This case preliminarily validates its anti-tumor activity and safety characteristics, and presents a novel therapeutic strategy for later-line management.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2632451"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13102035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147730524","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 social media use on influenza vaccine hesitancy among pediatric healthcare workers: The mediating role of 3Cs.","authors":"Li Nie, Ying Deng, Qing Yu, Qian Zhou, Wanjun Luo","doi":"10.1080/21645515.2026.2670818","DOIUrl":"10.1080/21645515.2026.2670818","url":null,"abstract":"<p><p>Evidence on the association between social media use and vaccine hesitancy has been inconsistent, and research on the mechanisms underlying this relationship remains limited. This study aimed to examine whether confidence, complacency, and convenience (3Cs) mediate the association between social media use and influenza vaccine hesitancy. An online questionnaire survey was conducted among 464 pediatric healthcare workers in a tertiary hospital in December 2024. The questionnaire assessed social media use (including trust and exposure), vaccine hesitancy, and the 3Cs. Reliability and validity were examined. Structural equation modeling (SEM) was used to estimate the direct and indirect effects of social media use on vaccine hesitancy. The model included social media trust, social media exposure, the 3Cs, and vaccine hesitancy as key variables. Convenience sampling was used. A total of 439 valid questionnaires were included in the analysis. The measures of vaccine hesitancy, social media use, and 3Cs demonstrated good reliability and validity. The Cronbach's α coefficients were 0.797, 0.928, and 0.859, respectively, and the corresponding Kaiser-Meyer-Olkin (KMO) values were 0.908, 0.882, and 0.91. Confidence significantly mediated the association between social media use and vaccine hesitancy, accounting for 34.9% of the total effect of social media trust on vaccine hesitancy (<i>p</i> = .001) and 30.7% of the total effect of social media exposure on vaccine hesitancy (<i>p</i> = .001). Greater trust in social media and greater exposure to vaccine-related information may be associated with lower influenza vaccine hesitancy among pediatric healthcare workers, primarily through increased vaccine confidence. Governments and health institutions should make better use of social media to disseminate evidence-based vaccine information through official channels and curb the spread of misinformation.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2670818"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13174001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934810","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":"Descriptive analysis of routine childhood vaccination coverage of selected vaccines in Nigeria (1980-2023) using the Global Burden of Disease Study (2023).","authors":"Adewunmi Akingbola, Abiodun Adegbesan, Olajumoke Adewole, Nwaeze Emmanuel, Opeyemi Joshua Alabi, Petra Mariaria","doi":"10.1080/21645515.2026.2684092","DOIUrl":"10.1080/21645515.2026.2684092","url":null,"abstract":"<p><p>Routine childhood immunization remains an effective public health intervention for reducing childhood morbidity and mortality from vaccine-preventable diseases. This study examined trends in routine childhood vaccination coverage in Nigeria from 1980 to 2023. We conducted a retrospective secondary descriptive analysis using routine childhood vaccination coverage estimates from the Global Burden of Disease Study 2023. Annual national coverage estimates for BCG, DTP3, Polio3, MCV1, and HepB3 vaccines were analyzed from 1980 to 2023. Temporal trends were assessed using line plots and forest plots with associated 95% uncertainty intervals, and the highest and lowest performing years for each vaccine were identified. Coverage for all assessed vaccines was lowest in 1980, followed by gradual expansion during the late 1980s and early 1990s, stagnation between the mid-1990s and early 2000s, and improvement after 2005. Peak coverage occurred between 2019 and 2021 for most vaccines, with BCG reaching the highest in 2021 at 73.6% (95% UI: 64.7-78.3). However, no vaccine achieved the WHO target of 90% national coverage throughout the study period. Although Nigeria has made measurable progress in routine childhood immunization over four decades, coverage remains below optimal levels, highlighting the need for targeted and equitable immunization strategies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2684092"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148206583","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":"Age- and sex-related variation in ChatGPT-4o HPV vaccine recommendation style: A fixed-prompt audit.","authors":"Nutthaporn Chandeying, Therdpong Thongseiratch","doi":"10.1080/21645515.2026.2718676","DOIUrl":"10.1080/21645515.2026.2718676","url":null,"abstract":"<p><p>ChatGPT is increasingly consulted for vaccine information, but demographic variation in recommendation framing is understudied. We audited ChatGPT-4o (1-2 May 2025) using 720 prompt instances from 156 coded seed prompts: one eligibility anchor and 12 misconception-based prompts across six age bands and two sex framings, each with 4-5 lexical variants. Replies were classified as presumptive, strong, shared decision-making, or recommend-against. Bayesian mixed-effects logistic models were fitted at the seed-prompt cluster level, with sex, age band, and their interaction as fixed effects and random intercepts for prompt topic and age-by-topic cluster (inter-coder kappa = 0.93). Through age 26y, all instances were directive. At ages 27-45y, the adjusted probability of a strong recommendation was 14.0% for women vs. 68.7% for men (difference, -54.7% points [95% credible interval, -71.8 to -32.8]; adjusted odds ratio [aOR], 0.04 [95% CrI, 0.008-0.19]). After age 45y, the adjusted probability of a recommend-against response was 59.9% for women vs. 41.1% for men (difference, 18.8% points [95% CrI, -5.4 to 40.8]; aOR, 2.40 [95% CrI, 0.77-7.50]). The 27-45y contrast remained clear after cluster adjustment; the >45y contrast was imprecise. This study evaluated recommendation style, not factual accuracy, guideline adherence, or vaccination behavior.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2718676"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13502007/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148800441","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":"Health care providers' perspectives on county-level barriers and facilitators to HPV vaccination: A socio-ecological approach (2022-2023).","authors":"Rida A Khatri, Gregory D Zimet, Monica L Kasting, Katharine J Head","doi":"10.1080/21645515.2026.2734052","DOIUrl":"10.1080/21645515.2026.2734052","url":null,"abstract":"<p><p>In Indiana, HPV vaccine series completion is 59.6%. Using a socio-ecological model (SEM) approach, this study investigates county health department providers' perspectives on improving vaccine initiation and completion among adolescents in Indiana. We conducted semi-structured interviews to explore health department providers' opinions on barriers and facilitators of HPV vaccine series initiation and completion amongst parents of adolescents. Thematic analysis was then conducted on the transcribed interviews. Interviews were conducted with 24 county health department providers across Indiana with 54.2% (n = 13) holding a Vaccine Coordinator position. Perceived barriers to initiation at the individual level included the parents' lack of education regarding the HPV vaccine and the importance of prevention. Interpersonally, misinformation and busy schedules for both the parents and adolescents hindered initiation and completion. Further, the presentation of the vaccine by the clinic could affect initiation and completion rates (both positively and negatively). Organizationally, having reminder systems regarding follow-up appointments was a facilitator to completion. Community-level barriers included a lack of providers, transportation, and language issues, but flexible scheduling options were a facilitator. Policy barriers included HPV not being a school-required vaccine. Participants provided valuable insight into perceptions of the HPV vaccine and the barriers and facilitators to HPV vaccine series initiation and completion in Indiana. Barriers to series completion included lack of information and conflicting schedules. Facilitators of series completion included reminder systems and flexible vaccination scheduling options. Interventions that include these facilitators can be developed to improve completion.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2734052"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149117372","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":"Knowledge and attitudes of medical students about human papillomavirus (HPV) and HPV vaccine: A cross-sectional survey in Inner Mongolia, China.","authors":"Xiaoxia Zhou, Dan Yao, Taishun Li, Zongliang Guo, Meng Jiang, Bilige Sude, Yi-Hua Zhou, Haixia Meng","doi":"10.1080/21645515.2026.2738975","DOIUrl":"10.1080/21645515.2026.2738975","url":null,"abstract":"<p><p>China approved human papillomavirus (HPV) vaccines for women and men in 2016 and 2025 respectively. We aimed to online survey the knowledge of HPV and HPV vaccines, as well as the vaccine uptake, among medical college students in Inner Mongolia, during April 1-21, 2026. Of 5,846 eligible students, 660 (11.3%) participated in the survey. Fourteen respondents were excluded because of their incomplete questionnaires. Of 646 respondents aged 20.5 (±1.5) years with 65.5% (423) females, 93.6% and 87.6% were aware of HPV and HPV vaccines respectively. However, only 74.8% of them knew HPV as the main cause of cervical cancer and 73.5% knew the preventive effect of HPV vaccines against cervical cancer. Fewer respondents knew the association of HPV with other cancers. The males had less knowledge than females. Only 115 (27.2%) females had received HPV vaccination, and none of the males did due to transient availability of the vaccine for males. Family income, paternal education, and HPV vaccine knowledge were the main factors associated with the vaccination. The vaccination barriers included vaccine cost, perceived lack of necessity, doubts about effectiveness, concerns about adverse events, and unawareness of where to get vaccinated. Among the unvaccinated respondents, 61.4% (137/223) of the males and 86.4% (266/308) of the females intended to get vaccinated. The survey revealed gaps in HPV and HPV vaccine knowledge, as well as low vaccination coverage among medical students. The results indicate that enhancing education about HPV and HPV vaccines appears valuable for increasing HPV vaccine uptake.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2738975"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070465","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":"Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials.","authors":"Faye Yu, Eugene Myshkin, Brandon Nguyen, Carolina Bobadilla Mendez, Marta Cossu, Kaiyin Fei, Qingmin Wang, Jonathan J Hubbard, Kim Campbell, Sindhu Ramchandren, Ricardo Rojo Cella, Robert Edwards, Peter C Taylor, Jacques-Eric Gottenberg, Ghaith Noaiseh, Tuan Vu, Carlo Antozzi, Kevin L Winthrop, Carolyn A Cuff, Matthew J Loza, Dessislava Dimitrova, Sheng Gao","doi":"10.1080/21645515.2026.2664331","DOIUrl":"10.1080/21645515.2026.2664331","url":null,"abstract":"<p><p>Nipocalimab is a neonatal Fc receptor (FcRn)-blocking monoclonal antibody approved for the treatment of generalized myasthenia gravis (gMG) and is being evaluated for other immunoglobulin G (IgG) autoantibody- or alloantibody-mediated diseases. Nipocalimab binds to FcRn with high specificity and affinity, eliciting increased clearance of IgG antibodies without affecting IgG production or other immune functions. However, nipocalimab's impact on vaccine responses in patients has not been previously reported. The effect of nipocalimab on pre-existing antibodies against tetanus toxoid (TT) and herpes zoster virus (HZV) vaccines as well as humoral responses to TT vaccines, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, and SARS-CoV-2 infections was examined in post hoc analyses of data from three randomized, placebo-controlled trials in participants with gMG, rheumatoid arthritis, and Sjögren's disease. The levels of pre-existing anti-TT and anti-HZV IgG followed the kinetics of total IgG during nipocalimab treatment (60%-65% and 53%-68% IgG reduction, respectively) and returned to baseline after discontinuation. Nevertheless, the majority of nipocalimab-treated participants maintained pre-existing anti-HZV (66/90, 73.3% above ≥100 IU/L reference threshold) and anti-TT IgG levels (62/81, 76.5% ≥0.16 IU/mL protective threshold) throughout the study period. Participants treated with nipocalimab elicited positive IgG responses to TT and SARS-CoV-2 vaccination, similar to placebo-treated participants. SARS-CoV-2 infections during the studies were mild to moderate in severity with no complications. These results suggest that nipocalimab does not impair the development of humoral responses to vaccines or viral infections in patients with IgG autoantibody-mediated diseases.<b>Trial registration number</b>: NCT04951622, NCT04991753, NCT04968912.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"22 1","pages":"2664331"},"PeriodicalIF":4.2,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13155020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147845020","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}