Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3–6 years and 2–35 months of age- an open-label, randomized phase IIb clinical trial

Abstract Background Enterovirus A71 (EV-A71) infection can cause severe debilitating complications and even death in young children. The immunogenicity and safety of an inactivated whole EV-A71 virus vaccine were assessed in children 2 months to 6 years of age. Methods This was an open-label, multi-center and randomized phase IIb study, which divided into part A and B. In part A, children 36 months to 6 years of age were enrolled and randomized into 3 groups, receiving 0.5 μg total viral protein (TP) with adjuvant Al(OH)3, 1.0 μg TP with Al(OH)3 or 1.0 μg TP only. Two doses of vaccines were administered at a 28-day interval and blood was taken before immunization, at week 4, 8, 28 and 52 (optional) for virus neutralization assay. Safety profiles were also monitored. After safety profiles had shown no concerns, children 2 months to 35 months of age (part B) were subsequently enrolled following the same protocol. Results A total of 135 children completed two doses of immunization, including 58 in part A and 77 in part B. Both adjuvanted 0.5 μg and 1.0 μg TP elicited significant raise of neutralizing antibody titers and seroconversion rate was up to 93.75–100.0% after 2 doses of immunization. Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP. By contrast, non-adjuvanted 1.0 μg TP was not immunogenic. No major adverse events were reported. Conclusions This EV-A71 vaccine containing adjuvant is immunogenic and safe in children 2 months to 6 years of age. Clinical Trials Registration. NCT03268083 .