Hepatitis A Clinical Trial
Official title:
The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children
A double-blind, randomized and controlled clinical trial was conducted in healthy children
aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of
a preservative-free inactivated hepatitis A vaccine (Healive®).
Participants who completed their primary vaccination were invited to participate in the
follow-up phase. Written informed consents were obtained from them. The follow-up study was
open-label. These subjects were visited in the next 11 years for blood sampling and
assessment of immune persistence induced by vaccination.
The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A
vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.
Total 400 subjects were enrolled and assigned into four groups, each receiving one of the
three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers
were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as
seroprotection.
After the full immunization schedule, written informed consents were obtained from subjects
who would like to participate in the follow-up study. Blood samples of these subjects were
collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the
seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against
hepatitis A virus. Serological results of the follow-up study were then used to explore
suitable statistical model for predicting the persistence of hepatitis A vaccine-induced
antibodies.
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