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.
del Canho
R
R
Department of Internal Medicine II, University Hospital Dijkzigt, Rotterdam, The Netherlands.
Grosheide
P M
PM
Voogd-Schotanus
M
M
Huisman
W M
WM
Heijtink
R A
RA
Schalm
S W
SW
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