Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years.
In a randomized, controlled trial, 105 healthy full-term infants born to HBsAg and HBeAg positive mothers received three doses (at 0, 1 and 6 months) of either a new recombinant hepatitis B vaccine (Hepavax-Gene) or Engerix-B. Both groups were also given hepatitis B specific Hepa-big immunoglobulin (HBIG) within 24h of birth. Levels of antibodies to hepatitis B surface antigen (anti-HBs) were assessed on days 30, 60, 210, 360, and 2 years post-vaccination. Efficacy and immunogenicity and safety of the two vaccines were not significantly different; both vaccines achieved >94% seroprotection within 360 days. At 2 years, only one subject (1.9%) in the Hepavax-Gene group and two subjects (3.9%) in the Engerix-B group were HBsAg positive. No serious adverse events (AEs) were observed in either group.
Hieu
Nguyen Trong
NT
Neonatology Department, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam.
Kim
Kyung Ho
KH
Janowicz
Zbigniew
Z
Timmermans
Ivo
I
D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000150:complications / Q000276:immunology / Q000517:prevention & control; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*; D006513:Hepatitis B e Antigens / Q000097:blood; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology; D012449:Safety; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*; D014744:Vietnam
C075654:Engerix-B; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D014614:Vaccines, Synthetic