Authors
Muhammad Gilang Dwi Putra^a, Rodman Tarigan Girsanga, Rais Amaral Haq^b, Teuku Fais Duta^c, Frengki Prabowo Saputro Wijayanto^d, Artha Maressa Theodora Simanjuntak^d, Eddy Fadlyana^a and Kusnandi Rusmil^a

Affiliations
^aClinical Research Unit, Child Health Department, Faculty of Medicine Universitas Padjadjaran, Bandung, Indonesia; bMedical Education Study Program, Faculty of Medicine, Universitas Lampung, Bandar Lampung, Indonesia; ^cMedical Education Study Program, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia; ^dMedical Education Study Program, Faculty of Medicine Public Health and Nursing, Gadjah Mada University, Yogyakarta, Indonesia

Background

• Enterovirus 71 (EV-A71) is a principal cause of hand, foot, and mouth disease (HFMD) and can lead to severe neurological complications in children.

• Inactivated EV-A71 vaccines have been introduced.

Methods

• Systematic review and meta-analysis with a PROSPERO-registered protocol.

• Randomized trials in children searched via PubMed, Scopus, Cochrane, and ClinicalTrials.gov.

• Five phase III trials involving 36,659 children.

Key Results

• Vaccination significantly increased seropositivity in early, medium-term, and long-term follow-up.

• Seroconversion was significantly higher in vaccinated children (pooled RR 13.04).

• Efficacy against EV-A71-associated HFMD exceeded 98%, with mild adverse events comparable to placebo.

Discussion & Conclusion

• Inactivated EV-A71 vaccines show robust immunogenicity, high efficacy, and an acceptable safety profile.

• Future studies should explore long-term protection, booster schedules, and multivalent formulations.

Related SDGs

SDG 3: Good Health and Well-Being – Protecting children through vaccination

Journal Information

Journal: Expert Review of Vaccines

DOI: https://doi.org/10.1080/14760584.2026.2722426