Reactogenicity and Immunogenicity of an Enterovirus 71 Vaccine in Chinese Healthy Children and Infants
- 1 November 2012
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in The Pediatric Infectious Disease Journal
- Vol. 31 (11), 1158-1165
- https://doi.org/10.1097/inf.0b013e31826eba74
Abstract
Enterovirus 71 (EV71) is highly contagious and can cause severe complications. A safe and effective vaccine is needed. We assessed the reactogenicity and immunogenicity of an inactivated, alum-adjuvanted EV71 vaccine in this study. A randomized, double-blind, placebo-controlled clinical trial was undertaken in 360 healthy participants who were stratified into 2 age groups (6–12 and 13–60 months), and randomly allocated to receive placebo or the investigational vaccine containing 160 U, 320 U or 640 U antigen per dose by the ratio of 1:1:1:1 at days 0 and 28. Reactogenic data within 28 days after each vaccination were recorded. Blood samples were obtained on days 0, 28 and 56 for neutralizing antibody assay. Overall, 193 participants reported at least 1 injection-site or systemic adverse reaction with 53.3% and 54.4% participants receiving the study vaccine and placebo, respectively. Most of the reactions were mild or moderate. Three serious adverse events were observed, but none was related to vaccination. In the participants with seronegative baseline, after 2 doses all the participants receiving EV71 vaccines were seropositive and the seroconversion rates were more than 98.1%. In the participants with seropositive baseline, 1 dose induced good seroconversion rates of more than 64.3% in participants receiving EV71 vaccines. This study found that the inactivated EV71 vaccine was well tolerated and had good immunogenicity in healthy children and infants. A single dose induced typical booster response in the participants with a seropositive baseline, and 2 doses were needed for the immunologically naive participants.Keywords
This publication has 26 references indexed in Scilit:
- Retrospective Study of the Incidence of HFMD and Seroepidemiology of Antibodies against EV71 and CoxA16 in Prenatal Women and Their InfantsPLOS ONE, 2012
- Incidence Rates of Enterovirus 71 Infections in Young Children during a Nationwide Epidemic in Taiwan, 2008–09PLoS Neglected Tropical Diseases, 2012
- Purification and Characterization of Enterovirus 71 Viral Particles Produced from Vero Cells Grown in a Serum-Free Microcarrier Bioreactor SystemPLOS ONE, 2011
- Immunogenicity and safety of a two-dose schedule of whole-virion and AS03A-adjuvanted 2009 influenza A (H1N1) vaccines: a randomised, multicentre, age-stratified, head-to-head trialThe Lancet Infectious Diseases, 2011
- Clinical features, diagnosis, and management of enterovirus 71The Lancet Neurology, 2010
- An Investigation of Epidemic Enterovirus 71 Infection in Taiwan, 2008The Pediatric Infectious Disease Journal, 2010
- Formaldehyde-Inactivated Whole-Virus Vaccine Protects a Murine Model of Enterovirus 71 Encephalomyelitis against DiseaseJournal of Virology, 2010
- DNA vaccine constructs against enterovirus 71 elicit immune response in miceGenetic Vaccines and Therapy, 2007
- Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trialThe Lancet, 2006
- An Epidemic of Enterovirus 71 Infection in TaiwanNew England Journal of Medicine, 1999