The safety and immunogenicity of a recombinant hepatitis B vaccine in neonates.
A study to evaluate the safety and immunogenicity of a yeast derived recombinant DNA hepatitis B vaccine (Engerix-B) was conducted in healthy newborn infants born to low risk European mothers negative for hepatitis B surface antigen (HBsAg). The vaccination schedule using 20 micrograms doses was administered intramuscularly at 0, 1 and 6 months. The seroconversion rate was 99% (90 of 91 infants). The geometric mean titer of antibody to hepatitis B was 1259 mIU/mL one month after the third dose of vaccine. Possible side effects reported by the mothers were minor and uncommon. This vaccine is highly immunogenic and safe for use in infants.
Gunn
T R
TR
St Helens Hospital, Auckland.
Bosley
A
A
Woodfield
D G
DG
D004341:Drug Evaluation; D005060:Europe / Q000208:ethnology; D005260:Female; D006509:Hepatitis B / Q000208:ethnology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006512:Hepatitis B Core Antigens / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D017325:Hepatitis B Vaccines; D006801:Humans; D007115:Immunization Schedule; D007231:Infant, Newborn; D009520:New Zealand; D014612:Vaccines / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014612:Vaccines; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines