The Pediatric infectious disease journal
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Pediatr. Infect. Dis. J. · Jul 2011
Randomized Controlled Trial Comparative StudySafety and immunogenicity of a modified process hepatitis B vaccine in healthy infants.
A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to be well tolerated and immunogenic in adults. The current study tested a 2-, 4-, 6-month vaccination schedule and a higher dose formulation (10 μg mpHBV) in healthy infants. ⋯ All 4 hepatitis B vaccines elicited high anti-HBs SPRs. After dose 3, anti-HBs GMT were highest in the 10 μg mpHBV group, but did not meet the predefined criteria for superiority. All vaccines were well tolerated.