title: 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.
abstract: 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.
authors.affiliation: Neonatology Department, Hung Vuong Hospital, Ho Chi Minh City, Viet Nam.
authors.forename: Nguyen Trong
authors.initials: NT
authors.lastname: Hieu
authors.forename: Kyung Ho
authors.initials: KH
authors.lastname: Kim
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Janowicz
authors.forename: Ivo
authors.initials: I
authors.lastname: Timmermans
mesh_terms: 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
chemical_list: C075654:Engerix-B; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D014614:Vaccines, Synthetic