Clinical and Experimental Vaccine Research最新文献

{"title":"Survival after primary and booster COVID-19 vaccination in patients with COPD.","authors":"Sevim Selen Karabulut, Aslı Nemli, Yalçın Koçyiğit","doi":"10.7774/cevr.2026.15.e1","DOIUrl":"10.7774/cevr.2026.15.e1","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate the primary vaccination status against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the administration of variant-modified vaccine boosters and the 1-year survival due to coronavirus disease 2019 (COVID-19) in individuals over 65 years old diagnosed with chronic obstructive pulmonary disease (COPD).</p><p><strong>Materials and methods: </strong>This cross-sectional study was conducted between July 2021 and February 2023. Among 108 COPD patients registered with the home healthcare unit, 97 were included after informed consent. Demographic and clinical characteristics (age, sex, vaccine type, dose count, smoking, diabetes, hypertension) were evaluated for their impact on mortality and survival. The Log-rank test assessed associations with one-year mortality, and Cox regression evaluated independent effects.</p><p><strong>Results: </strong>Among participants, 64% were aged 65-75 and 52% were male. Of these, 41% completed only the primary vaccination series (2 doses) and 29% received a booster dose. By one-year follow-up, 38% (n=37) had died due to COVID-19. Vaccination status (p=0.018), number of doses (p=0.017), and diabetes (p=0.001) were significantly associated with mortality. Cox analysis indicated diabetes (Exp[β]=3.125) and incomplete vaccination (Exp[β]=0.456) significantly decreased survival (p<0.05).</p><p><strong>Conclusion: </strong>Completing at least the primary vaccination series was associated with improved survival, while incomplete primary vaccination and comorbid diabetes had negative effects on outcomes. Booster dose uptake was lower than completion of the primary series. Routine SARS-CoV-2 vaccination remains essential for protecting vulnerable populations, especially amid the ongoing emergence of new variants.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"57-62"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The relationship between COVID-19 vaccination attitudes and COVID-19-related parameters with mental health problems: the potential role of behavioral issues.","authors":"Caner Mutlu, Emine Büşra Ölmez, Celal Yeşilkaya, Hande Kırışman Keleş, Esra Rabia Taşpolat, Serkan Turan, Şafak Eray Çamlı","doi":"10.7774/cevr.2026.15.e4","DOIUrl":"10.7774/cevr.2026.15.e4","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to examine the relationship between coronavirus disease 2019 (COVID-19) vaccination status and psychiatric symptoms, illness perceptions, avoidance behaviors, and familial vaccination patterns in adolescents referred to a child and adolescent psychiatry outpatient clinic.</p><p><strong>Materials and methods: </strong>This cross-sectional observational study included adolescents (n=168) aged 12-18 years. Participants were categorized as vaccinated (n=74, 44%) or unvaccinated (n=94, 56%). Data were collected using validated instruments, including the Coronavirus Anxiety Scale, Clinical Global Impression-Severity, Strengths and Difficulties Questionnaire-Parent version, and several scales evaluating COVID-19 perceptions, control beliefs, avoidance attitudes, and vaccine attitudes. Mann-Whitney U and χ² tests were used for group comparisons. Binary logistic regression was performed to identify predictors of vaccination status.</p><p><strong>Results: </strong>Vaccinated adolescents were significantly older, more likely female, and more frequently had vaccinated siblings and mothers (p<0.05). They reported higher behavioral avoidance and more positive attitudes toward vaccination, while displaying lower hyperactivity/inattention symptoms (p<0.05). Logistic regression revealed that female gender (odds ratio [OR], 5.11; 95% confidence interval [CI], 1.67-15.64), older age (OR, 1.82; 95% CI, 1.38-2.40), sibling vaccination (OR, 4.53; 95% CI, 1.55-13.25), and increased peer problems (OR, 1.40; 95% CI, 1.02-1.93) significantly predicted vaccination status (p<0.05).</p><p><strong>Conclusion: </strong>In psychiatrically referred adolescents, COVID-19 vaccination is associated with demographic, familial, and psychological variables. Positive vaccine attitudes, behavioral avoidance, and family modeling increase the likelihood of vaccination, whereas hyperactivity/inattention symptoms may reduce it.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"24-34"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12877060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge, attitudes and practices towards immunization among adult population in a tertiary care hospital-exploratory survey.","authors":"Nischala Patlolla, Vijay Yeldandi, Shilpa Aralikar, Saisree Sangireddy, Juveria Siddiqua, Anisha Merin Varghese, Chandralekha, Mohammad Abdul Sameem, Madani, Sathees Vidya Chaitanya, Mounika Bai, Sirisha","doi":"10.7774/cevr.2026.15.e8","DOIUrl":"10.7774/cevr.2026.15.e8","url":null,"abstract":"<p><strong>Purpose: </strong>Adult immunization is underutilized in India due to limited awareness, inconsistent provider recommendations, and vaccine hesitancy. This study aimed to assess knowledge, attitudes, and practices (KAP) toward adult vaccination and evaluate the impact of educational interventions on vaccine uptake.</p><p><strong>Materials and methods: </strong>An exploratory cross-sectional survey was conducted among 539 adults (≥18 years) attending inpatient and outpatient services in a tertiary care private hospital, Hyderabad, between September and December 2023. Data on awareness, attitudes, and vaccination history were collected using a structured questionnaire. Vaccine consumption rates in 2023 (pre-intervention) and 2024 (post-intervention) were compared to assess behavioural change. Descriptive statistics were applied for analysis. An educational intervention was carried out by the clinical pharmacist and physicians on the prominence of adult immunization for the participants. Adult immunizations were offered to all participants, subject to purchase, and were subsequently administered at the Adult Immunization Center.</p><p><strong>Results: </strong>Of the respondents, 61% were male and 39% female. A majority (94%) agreed that adults should be vaccinated, and 92% recognized the importance of timely immunization. However, only 62% reported receiving provider recommendations, and 66% had been educated on vaccination. Coronavirus disease 2019 vaccination was the most common (n=493), followed by hepatitis B (n=92), tetanus, diphtheria, and pertussis (Tdap) (n=68), and Influenza (n=63). Post-intervention analysis showed substantial increases in vaccine uptake: human papillomavirus (+116.9%), shingles (+421.4%), hepatitis A (+74.5%), and Tdap (+34.1%).</p><p><strong>Conclusion: </strong>While awareness and positive attitudes toward adult immunization are high, gaps persist in education and provider recommendation. Educational interventions significantly improved vaccine uptake, underscoring the role of clinical pharmacists in bridging the knowledge-practice gap and enhancing adult vaccination uptake.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"88-95"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endocrine disorders following SARS-CoV-2 vaccination: a comprehensive systematic review.","authors":"Cielo Cinthya Calderon-Hernandez, Nelson Luis Cahuapaza-Gutierrez, Tatiana Vanessa Villavicencio-Escudero, Claudia Vanessa Ibárcena-Llerena, Cristina Quiroz-Narvaez, Helya Yusara Coronado-Quispe, Nallely V Chapoñan-Agip","doi":"10.7774/cevr.2026.15.e6","DOIUrl":"10.7774/cevr.2026.15.e6","url":null,"abstract":"<p><strong>Purpose: </strong>To synthesize and analyze the current available evidence on the development of new-onset endocrine disorders associated with coronavirus disease 2019 (COVID-19) vaccination.</p><p><strong>Materials and methods: </strong>We performed a systematic review of literature by searching PubMed, Scopus, Embase and Web of Science. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were applied, the Joanna Briggs Institute tool and New Castle-Ottawa score were used to assess the risk of bias and quality. SPSS 25.0 software was used for statistical analysis.</p><p><strong>Results: </strong>A total of 245 patients were reported from the selected studies. The most frequently reported endocrine disorders associated with COVID-19 vaccination were thyroid conditions (70.6%), primarily subacute thyroiditis (69.9%) and Graves' disease (28.9%). Cases of type 1 diabetes mellitus (10.2%), adrenal disorders (9.8%), and pituitary disorders (9.4%) were also identified. Most cases occurred in women (64%) and following the first vaccine dose (50.6%). Messenger ribonucleic acid-based vaccines primarily Pfizer-BioNTech and Moderna were the most reported (56.7%). Additionally, studies on fertility found no significant adverse effects on ovarian reserve or semen quality. Clinical outcomes were favorable in most cases (82%), with no significant mortality reported.</p><p><strong>Conclusion: </strong>Overall, although cases of endocrine disorders following COVID-19 vaccination have been reported, a causal relationship has not been definitively established. The benefits of vaccination significantly outweigh the potential risks of endocrinological complications at both the individual and population levels. Nevertheless, clinicians should remain alert to the possibility of endocrine manifestations following vaccination.</p><p><strong>Trial registration: </strong>PROSPERO identifier: CRD42024512710.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"35-56"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12877070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunoinformatics and molecular docking reveal potential multi-epitope vaccine against <i>Pseudomonas aeruginosa</i>.","authors":"Derreck O De Leon, Andrei Justin F So, Ma Vianca Julia E Anupol, Keona Tiffany B Prieto, Mellissa Jewel S Magday, Alexa Charlize D C Geronimo, Edward Kevin B Bragais","doi":"10.7774/cevr.2026.15.e2","DOIUrl":"10.7774/cevr.2026.15.e2","url":null,"abstract":"<p><strong>Purpose: </strong><i>Pseudomonas aeruginosa</i> is a common opportunistic pathogen and a leading cause of hospital-acquired pneumonia, yet there is currently no approved vaccine to prevent its infections. This study utilizes immunoinformatics to identify cytotoxic T-lymphocyte (CTL) epitopes derived from conserved regions of 6 key virulence factors: Pili, FliD, AlgF, PelG, Exoenzyme T, and XcpQ.</p><p><strong>Materials and methods: </strong>Conserved peptide fragments were identified using the Protein Variability Server. The CTL epitopes were evaluated for immunogenicity, antigenicity, post-translational modifications, allergenicity, cross-reactivity, toxicity, and population coverage analysis. Molecular docking between human leukocyte antigens (HLAs) and the corresponding CTL epitopes, along with binding affinity analysis, was also conducted. A multi-epitope vaccine (PaMEV) construct was designed using selected epitopes, and its secondary and tertiary structures were predicted, refined, and validated.</p><p><strong>Results: </strong>All selected epitopes were highly conserved (Shannon index ≤0.1) and showed strong HLA binding (half maximal inhibitory concentration ≤500 nM). They were predicted to be non-allergenic, non-toxic, and non-cross-reactive. Molecular docking revealed stable HLA-epitope complexes with 8-14 hydrogen bonds and high binding affinity (values of the binding free energy <0 and dissociation constant <100 nM). A PaMEV was designed using the 6 CTL epitopes, and structure analysis confirmed its stability and effective epitope presentation.</p><p><strong>Conclusions: </strong>The selected epitopes showed strong potential for inclusion in a peptide-based PaMEV, with favorable immunogenicity and docking results supporting its design. The final construct exhibited structural stability and strong HLA interactions, suggesting it as a promising vaccine candidate against <i>P. aeruginosa</i>. Experimental validation through <i>in vitro</i> and <i>in vivo</i> studies is recommended.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"71-87"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Temporal dynamics of IgM and IgG after COVID-19 vaccination: a pilot cohort study on breakthrough infections.","authors":"Jingyun Wang, Xitong Li, Yaochen Cao, Xin Chen, Christoph Reichetzeder, Berthold Hocher","doi":"10.7774/cevr.2026.15.e7","DOIUrl":"10.7774/cevr.2026.15.e7","url":null,"abstract":"<p><strong>Background: </strong>During the coronavirus disease 2019 (COVID-19) pandemic, we conducted a cohort study analyzing changes in immunoglobulin (Ig) M and IgG antibody levels before and after COVID-19 vaccination.</p><p><strong>Methods: </strong>The study compared two groups: participants who were infected with severe acute respiratory syndrome coronavirus 2 within 14 days of vaccination and those who were not. We evaluated dynamic changes in IgM and IgG levels immediately following vaccination and assessed their potential correlation with infection risk.</p><p><strong>Results: </strong>Participants who contracted COVID-19 within 14 days of vaccination exhibited significantly higher IgM antibody levels than uninfected individuals, likely due to combined stimulation by both the vaccine and the virus. In the infected group, IgG antibody levels were lower than those in the uninfected group during the first 1 to 5 days post-vaccination. Moreover, across all participants, IgG antibody levels were generally lower than baseline during the first 1 to 3 days post-vaccination.</p><p><strong>Conclusions: </strong>These findings suggest that, in the early stages following vaccination, the immune system may experience a temporary \"immune trough,\" potentially even below pre-vaccination levels. As a result, individuals should exercise additional caution during this period to mitigate infection risk.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"63-70"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing vaccine allocation: a review of epidemiological models with behavioral adaptation.","authors":"Ruhan Gudeli, Karthik Mangu, Himanshu Agarwal","doi":"10.7774/cevr.2026.15.e3","DOIUrl":"10.7774/cevr.2026.15.e3","url":null,"abstract":"<p><p>Accurate vaccine distribution remains central to epidemic management, particularly when resources are limited and public response varies. This revised review evaluates three epidemiological modeling approaches that guide vaccine allocation decisions: DELPHI-V-OPT (an integrated epidemiological-optimization framework), a hybrid Agent-Based plus Differential Equation model, and Probabilistic (stochastic) Control models. Building on the original manuscript, this revision adds a transparent literature-search methodology, a strengthened, chronological literature review, clearer technical descriptions (especially the bidirectional coupling between agent-based simulations and compartmental equations), and a comprehensive limitations and future-work section for each model. We justify the selection of DELPHI-V-OPT as the primary practical framework for policy use, then introduce and analytically integrate a behavioral variable representing vaccine hesitancy into the allocation optimization. The extension recalibrates effective demand, reduces dose wastage, and provides operational recommendations for estimating hesitancy and adapting allocations in resource-limited and resource-rich settings. The revised manuscript includes a summary comparison table of model features, explicit search strategy, and targeted references that support methodological choices and model adaptations.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"9-14"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876914/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeting intestinal microbiota with <i>Bifidobacterium breve</i> and <i>Hafnia alvei</i> probiotics does not improve response to influenza vaccine in mice.","authors":"Chloé Crouzillac, Méline Onzon, Grégory Unique, Grégory Chambon, Nicolas Barnich, Nicolas Bourgne, Elisabeth Billard","doi":"10.7774/cevr.2026.15.e9","DOIUrl":"10.7774/cevr.2026.15.e9","url":null,"abstract":"<p><p>The intestinal microbiota plays a critical role in shaping host immune responses to pathogens and vaccines. Dextran sulfate sodium-treated mice showed reduced vaccinal response following prime-boost immunization with purified ovalbumin, as confirmed by decreased specific immunoglobulin (Ig)G and IgM, confirming the negative impact of dysbiosis and associated inflammation. Two probiotic strains were selected, <i>Bifidobacterium breve</i> and <i>Hafnia alvei</i>, but none of them showed any enhancement of antibody or T cell responses following prime-boost influenza vaccination in mice. While probiotics remain promising for improving vaccine efficacy, especially in vulnerable populations, further research is needed to identify effective strains and optimize treatment protocols.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"96-100"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging risk of tick-borne diseases in South Korea: Lyme disease, anaplasmosis, and babesiosis.","authors":"Hong Sang Oh","doi":"10.7774/cevr.2026.15.e5","DOIUrl":"10.7774/cevr.2026.15.e5","url":null,"abstract":"<p><p>Tick-borne diseases are an emerging public health concern in South Korea, driven by climate change, ecological shifts, and increasing contact between humans, wildlife, and companion animals. This review aimed to provide an updated synthesis of 3 tick-borne infections of concern-Lyme disease, human granulocytic anaplasmosis, and babesiosis. Relevant literature, national surveillance data, and international guidelines were reviewed to describe pathogen characteristics, tick ecology, epidemiology, diagnosis, treatment, prevention, and climate-related risk. Evidence indicates that <i>Ixodes nipponensis</i> and <i>Haemaphysalis longicornis</i> are widely distributed and carry medically important pathogens. Reports of pathogen detection in humans, ticks, and animals suggest a growing ecological risk. Limited clinical awareness, insufficient diagnostic capacity, and underdeveloped surveillance systems remain major challenges. Climate change is expected to further extend tick activity periods, broaden their geographic distribution, and elevate infection risks. Strengthening diagnostic capabilities, integrating human-animal-environment data within a One Health framework, and advancing preventive strategies are critical to reducing the future burden of tick-borne diseases in South Korea.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"1-8"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reporting quality and risk of bias in randomized controlled trials of rotavirus vaccines.","authors":"Jiyoung Kim, Juhee Cho","doi":"10.7774/cevr.2026.15.e10","DOIUrl":"10.7774/cevr.2026.15.e10","url":null,"abstract":"<p><strong>Purpose: </strong>Although several randomized controlled trials (RCTs) have examined the efficacy of rotavirus vaccines, few have comprehensively assessed their reporting quality and risk of bias. This study aimed to evaluate the reporting quality and methodological rigor of RCTs on rotavirus vaccines using the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist and the Cochrane Risk of Bias 2.0 (RoB 2.0) tool.</p><p><strong>Materials and methods: </strong>We systematically searched PubMed and Cochrane Central for phase 3 randomized controlled trials of rotavirus vaccines administered as monotherapy. Reporting quality was assessed using the CONSORT 2010 checklist and risk of bias was evaluated with the Cochrane RoB 2.0 tool across five domains to determine overall methodological rigor.</p><p><strong>Results: </strong>A total of 29 phase 3 RCTs were included after screening 1,066 records. Most trials were conducted in Asia and funded by industry. Adherence to the CONSORT 2010 checklist was high for trial design and outcome reporting but poor for protocol availability, allocation concealment, and blinding procedures. Overall, 62% of studies had a low risk of bias, while 34% were rated high. Trials published after 2010 and those with low risk of bias showed significantly higher reporting quality.</p><p><strong>Conclusion: </strong>Adherence to the CONSORT 2025 guidelines is essential for future rotavirus vaccine trials, enhancing the quality of individual studies while reinforcing the broader evidence base that informs immunization strategies and public health policies.</p>","PeriodicalId":51768,"journal":{"name":"Clinical and Experimental Vaccine Research","volume":"15 1","pages":"15-23"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12876929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}