Abstract
Background and Aims: There are concerns with regards to the efficacy of combination (DTaP-IPV-HiB-HBV) vaccine, especially in infants with high risk of vertical transmission, and there has been no study comparing the vaccine efficacy in those receiving three doses of monovalent HBV vaccine versus two doses monovalent plus one dose of combination vaccine in infants of chronic HBVinfected mothers. The aim of this study is to examine the anti-HBs antibody levels of both vaccine regimens in a cohort of these highrisk infants. Methods: An observational cohort of term neonates was recruited from June 2009 to June 2014 from multiple primary to tertiary centres in Singapore. Anti-HBs antibody levels were measured at 9 months of age. Vaccine regimen administered were based on the individual institutions’ practice. Results: All term neonates received monovalent hepatitis B vaccine with hepatitis B immunoglobulin at birth with a repeat dose of monovalent hepatitis B vaccine at 1 month. They received either monovalent (n = 111) or combination vaccine (n =95) at 6 months. Baseline maternal age (31.3 year vs 32.9 years), hepatitis B e-antigen positivity (24% vs 28%, p = 0.78) and birth characteristics, including gestational age (38 weeks versus 38weeks, p = 0.34), birth weight (3.13 kg vs 3.16 kg, p = 0.62) were similar between groups. The mean anti-HBs antibody were both not statistically different (478 IU/L vs 469 IU/L, p = 0.88). Vaccine failure rate (anti-HBs antibody <10 IU/L) was 4.5% vs 4.7% (p =1.00). Vertical transmission rate (HBsAg or HBVDNA positive) was 1.8% vs 2.3% (p =0.78). Conclusions: For term neonates delivered by chronic HBVinfected mothers, both 3-dose monovalent and combination vaccine regimen showed similar vaccine efficacy, with no increased risk of vertical transmission.
Published Version
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