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Comparison of immunogenicity, safety, and efficacy of EVA71 vaccine in children: a systematic review and meta-analysis.

Muhammad Gilang Dwi Putra·Rodman Tarigan Girsang·Rais Amaral Haq·Teuku Fais Duta·Frengki Prabowo Saputro Wijayanto·Artha Maressa Theodora Simanjuntak·Eddy Fadlyana·Kusnandi Rusmil
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Abstract

INTRODUCTION: Enterovirus 71 (EV-A71) is a principal cause of hand, foot, and mouth disease (HFMD), potentially leading to severe neurological complications in children. Inactivated EV-A71 vaccines have been introduced. This study compares the immunogenicity, safety, and efficacy of EV-A71 vaccines versus placebo in pediatric populations. RESEARCH DESIGN AND METHODS: Following a PROSPERO-registered protocol, RCTs involving EV-A71 in children were identified via PubMed, Scopus, Cochrane, and ClinicalTrials.gov. Two independent reviewers performed screening, extraction, and RoB assessments (RoB 2.0). RESULTS: Five phase III RCTs involving 36,659 children were included. EV-A71 vaccination significantly increased seropositivity across follow-up periods, including early (RR 5.8), medium-term (RR 3.09), and long-term (RR 2.95) response. Seroconversion was significantly higher in the vaccinated group (pooled RR 13.04, 95% CI 2.80-60.61; p&#x2009;<&#x2009;0.001). Geometric mean titers, analyzed using the ratio of means approach, were significantly higher in the vaccinated group during early and medium-term follow-up. Vaccine efficacy against EV-A71-associated HFMD exceeded 98% (pooled RR 0.02, 95% CI 0.01-0.09; p = 0.0028; I2&#x2009;=&#x2009;50%). Solicited local and systemic adverse events were mild and comparable between groups. CONCLUSION: Inactivated EV-A71 vaccines robust immunogenicity, high clinical efficacy, and an acceptable safety profile in children. Future studies should explore long-term protection, booster schedules, and multivalent formulations against non-EV-A71 serotypes.

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HumansEnterovirus A, HumanVaccines, InactivatedHand, Foot and Mouth DiseaseRandomized Controlled Trials as TopicVaccine EfficacyViral VaccinesImmunogenicity, VaccineAntibodies, ViralChildClinical Trials, Phase III as TopicChild, PreschoolChildrenEV-A71 vaccineHFMDmeta-analysisplaceboJournal ArticleSystematic ReviewMeta-AnalysisComparative StudyReview

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Muhammad Gilang Dwi Putra, Rodman Tarigan Girsang, Rais Amaral Haq, Teuku Fais Duta, Frengki Prabowo Saputro Wijayanto, Artha Maressa Theodora Simanjuntak, Eddy Fadlyana, Kusnandi Rusmil. 2026-08-25. Comparison of immunogenicity, safety, and efficacy of EVA71 vaccine in children: a systematic review and meta-analysis.. https://doi.org/10.1080/14760584.2026.2722426

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Antibodies, Viral subjectChild subjectChild, Preschool subjectChildren subjectClinical Trials, Phase III as Topic subjectComparative Study subjectEV-A71 vaccine subjectEnterovirus A, Human subjectHFMD subjectHand, Foot and Mouth Disease subjectHumans subjectImmunogenicity, Vaccine subjectJournal Article subjectJournal Article; Systematic Review; Meta-Analysis; Comparative Study; Review resourceMeta-Analysis subjectSystematic reviews study

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