Abstract
Vaccination can effectively prevent hepatitis B virus (HBV) infection. Vaccination with 3 doses of hexavalent HBV-containing vaccines led to a higher Hepatitis B surface antibody (anti-HBs) antibody level than vaccination with 3 doses of pentavalent HBV-containing vaccines. Whether the substitution of one dose of hexavalent HBV-containing vaccine in the pentavalent regimen could lead to a higher anti-HBs antibody level remains unknown. A randomized, open-label controlled trial was conducted. Infants aged 30-120 days were randomly assigned to either a combined hexavalent/pentavalent regimen (hexavalent HBV-containing vaccine at 2 months of age and pentavalent HBV-containing vaccine at 4 and 6 months of age) or a 3-dose pentavalent regimen (pentavalent HBV-containing vaccine at 2, 4, and 6 months of age). Anti-HBs antibody levels were measured 3-6 months after the last vaccination. Seventy-six infants were enrolled, 38 in each group. The geometric mean of anti-HBs antibody levels in the combined hexavalent/pentavalent group was significantly higher than that of the 3-dose pentavalent group [316.2 mIU/mL (95% CI: 173.8-575.4 mIU/mL) versus 81.3 mIU/mL (95% CI: 38.9-169.8 mIU/mL), P = 0.006]. By multivariate analysis, the combined hexavalent/pentavalent regimen (coefficient 0.57; P = 0.003) was associated with higher anti-HBs antibody levels, while body weight <10th percentile (coefficient -0.85; P = 0.006) and receiving concomitant pneumococcal conjugated vaccines (coefficient -0.65; P = 0.001) were associated with lower anti-HBs antibody levels. Substituting the first dose with a hexavalent HBV-containing vaccine in the pentavalent regimen for HBV vaccination led to higher anti-HBs antibody levels in infants. Concomitant pneumococcal conjugated vaccine administration may have an adverse impact on anti-HBs antibody level.
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