» Articles » PMID: 30803843

Immunogenicity, Safety, Cross-reaction, and Immune Persistence of an Inactivated Enterovirus A71 Vaccine in Children Aged from Two Months to 11 Years in Taiwan

Overview
Journal Vaccine
Date 2019 Feb 27
PMID 30803843
Citations 12
Authors
Affiliations
Soon will be listed here.
Abstract

Background: To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was initiated in Taiwan focusing on two-month-old infants.

Methods: We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to <two years received a booster dose at one year after the first dose. During the surveillance period, solicited adverse events (AEs) and unsolicited AEs were recorded for safety evaluation. Blood samples were collected for neutralising antibody assay at various times. Immune persistence and booster effects were also assessed.

Results: A total of 363 children completed the study. Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly. Most participants in the vaccine groups achieved defined seroprotection (neutralization titre ≥ 1:32) after the second vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could provide a cross-reaction against other EV-A71 strain genotypes: B5, C4a, C4b, and C5.

Conclusions: The mid dose of the EV-A71 vaccine elicited high immune response and were tolerable in participants aged between two months and 11 years in all dosing groups.

Citing Articles

Long-Term Immunogenicity Study of an Aluminum Phosphate-Adjuvanted Inactivated Enterovirus A71 Vaccine in Children: An Extension to a Phase 2 Study.

Chiu N, Lin C, Chen C, Cheng H, Hsieh E, Liu L Vaccines (Basel). 2024; 12(9).

PMID: 39340018 PMC: 11435984. DOI: 10.3390/vaccines12090985.


Reflecting on the 1998 enterovirus outbreak: A 25-year retrospective and learned lessons.

Huang P, Hsia S, Huang K, Chen C, Wang E, Shih S Biomed J. 2024; 48(1):100715.

PMID: 38492637 PMC: 11751406. DOI: 10.1016/j.bj.2024.100715.


Enterovirus 71-Associated Infection in South Vietnam: Vaccination Is a Real Solution.

Romanenkova N, Nguyen T, Golitsyna L, Ponomareva N, Rozaeva N, Kanaeva O Vaccines (Basel). 2023; 11(5).

PMID: 37243035 PMC: 10221170. DOI: 10.3390/vaccines11050931.


Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19.

Harbin A, Laventhal N, Navin M Vaccine. 2023; 41(9):1584-1588.

PMID: 36732168 PMC: 9888531. DOI: 10.1016/j.vaccine.2023.01.055.


Genomic Epidemiology and Phylodynamic Analysis of Enterovirus A71 Reveal Its Transmission Dynamics in Asia.

Xiao J, Huang K, Lu H, Song Y, Han Z, Zhang M Microbiol Spectr. 2022; 10(5):e0195822.

PMID: 36200890 PMC: 9603238. DOI: 10.1128/spectrum.01958-22.