AI Article Synopsis
- The study evaluated the immunogenicity of two dosages (5 micrograms and 10 micrograms) of a recombinant DNA yeast-derived hepatitis B vaccine (HB-Vax-DNA) in healthy neonates born to HBsAg-negative mothers.
- No severe side effects were reported, with only 15.5% experiencing mild and temporary local symptoms, indicating the vaccine is safe.
- Both dosages were found to be effective, with the 10 microgram dose producing slightly higher antibody levels after initial vaccinations, suggesting either dosage could be included in the Netherlands' Expanded Programme on Immunization.
Article Abstract
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.
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| http://dx.doi.org/10.1016/s0264-410x(94)80059-9 | DOI Listing |
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