Immunogenicity of two different dosages (10 and 5 micrograms) of recombinant DNA hepatitis B vaccine in healthy neonates.
The immunogenicity of a half (5 micrograms) and a full (10 micrograms) dosage of recombinant DNA yeast-derived hepatitis B vaccine (HB-Vax-DNA) in healthy neonates was assessed in order to compare two candidate dosages of vaccine. After randomization 174 newborns of HBsAg-negative mothers entered the study. Neonates received four doses of either 10 or 5 micrograms hepatitis B vaccine, according to the DTP-polio immunization schedule at months 3, 4, 5 and 11. No serious adverse reactions were observed; 15.5% of vaccinated newborns suffered mild transient local symptoms. The vaccine was highly immunogenic irrespective of dosage of vaccine; all infants developed anti-HBs levels > or = 10 IU l-1, 99% > or = 100 IU l-1. A dosage of 10 micrograms hepatitis B vaccine produced higher antibody levels than 5 micrograms hepatitis B vaccine after primary vaccination (first three doses) but not after booster vaccination (fourth dose) (p = 0.06 and 0.75, respectively). Either vaccine dosage can be recommended for incorporation in the Expanded Programme on Immunization in the Netherlands.
Department of Internal Medicine II, University Hospital Dijkzigt, Rotterdam, The Netherlands.
R
R
del Canho
P M
PM
Grosheide
M
M
Voogd-Schotanus
W M
WM
Huisman
R A
RA
Heijtink
S W
SW
Schalm
D000914:Antibodies, Viral / Q000096:biosynthesis; D005260:Female; D005312:Fetal Blood / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D007112:Immunity, Maternally-Acquired / Q000276:immunology; D007231:Infant, Newborn; D008297:Male; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000276:immunology*
D000914:Antibodies, Viral; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic