Immunogenicity of 20 μg of recombinant DNA hepatitis B vaccine in healthy neonates: A comparison of three different vaccination schemes

Abstract

The immunogenicity of a full dose (20 micrograms) of recombinant DNA yeast-derived hepatitis B vaccine (Engerix-B) was assessed in healthy neonates in order to compare three candidate vaccination schemes. After randomization 162 newborns of hepatitis B surface antigen (HBsAg) negative mothers entered the study. Neonates received hepatitis B vaccine according to a four-dose vaccination scheme starting either at month 3 (scheme I: months 3, 4, 5, and 11) or at birth (scheme III: months 0, 1, 2, and 11). Another group of neonates received hepatitis B vaccine according to a three-dose scheme starting at birth (scheme II: months 0, 1, and 6). Serious adverse reactions were not observed; 2.5% of the vaccinated newborns suffered mild transient local symptoms. The vaccine was highly immunogenic irrespective of vaccination scheme; all infants developed anti-HBs levels > or = 10 IU/L, 97% > or = 100 IU/L. The immunogenicity of hepatitis B vaccine after primary and booster vaccinations, administered in the four-dose scheme started at birth, was significantly higher (P < 0.05) than in the three-dose scheme started at birth. Hepatitis B vaccination according to the four-dose scheme started at month 3 produced significantly higher (P < 0.05) antibody levels in comparison to the four-dose scheme started directly after birth. This study showed that a four-dose hepatitis B vaccination scheme starting at month 3 resulted in the highest antibody levels of the three schemes investigated and can be recommended for incorporation in the Expanded Programme on Immunization in The Netherlands.

Immunogenicity of two different hepatitis B vaccine schedules

“…These authors performed a randomized clinical trial on the immunogenicity of two different hepatitis B vaccine schedules, i.e., birth, 6 weeks, and 14 weeks (Group A) or 6, 10, and 14 weeks (Group B), and found that seroconversion rates for hepatitis B vaccine were comparable in the two groups. In contrast, two other studies [3, 4], similar to our study, revealed lesser seroconversion in infants whose vaccination started immediately after birth. Such data will contribute to the generation of recommendations on the optimal timing of the initial dose of hepatitis B immunization in infants.…”

Hepatitis B Vaccination: Long-Term Follow-up of the Immune Response of Preterm Infants and Comparison of Two Vaccination Protocols

“…This may be explained by the finding of del Canho et al [20] who reported that primary vaccination of full-term infants starting at 3 months of age resulted in peak antibody levels twice as high as in full-term infants vaccinated at birth. The delayed vaccination group was assumed to have greater immunologic maturity.…”

Immunogenicity of recombinant hepatitis B vaccine: comparison of two different vaccination schedules

“…The study of McMahon et al [6] revealed that children vaccinated in early childhood were more likely to have undetectable levels of hepatitis B surface antibody (anti-HBs) in late adolescence or young adulthood, when the risks for HB infection increase. Other studies have shown that lower seroconversion rates occurred in children after primary vaccination if they had received the vaccine immediately after birth [7–9]. …”