Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants

Background: A hepatitis B vaccine was manufactured with a modified process (mpHBV) that incorporated double the usual amount of phosphate. Following a study in young adults, the mpHBV was evaluated in infants in a combination hepatitis B and Haemophilus influenzae B vaccine (mpHBV-Hib). Methods: The mpHBV-Hib was compared with the licensed bivalent HBV-Hib vaccine Comvax (TM) for immunogenicity and safety. Both vaccines contained 5 mu g/0.5 mL of hepatitis B surface antigen (HBsAg) and 7.5 mu g/0.5 mL of PRP-OMPC (polyribosylribitol phosphate outer membrane protein complex). A total of 543 infants were randomized 1:1 to receive either vaccine at 2,4 and 12 months of age. A pneumococcal conjugate vaccine (PCV) was given concomitantly. Immunogenicity was assessed at 1-month post-dose 3. Results: Seroprotection rates [% subjects with anti-hepatitis B surface antigen antibody titers (anti-HBs) >= 10 mIU/mL)] were 100% and 99% for mpHBV-Hib and the licensed control (Comvax (TM)), respectively. Anti-HBs geometric mean titers (GMTs) were 4204 (95% CI, 3411-5182) and 1683 (95% CI, 1350-2099) mIU/mL, respectively. Anti-PRP seroprotection rates (SPR) at >= 0.15 mu g/mL and at >= 1.0 mu g/mL were 97% and 94%, respectively, for mpHBV-Hib and 96% and 92%, respectively, for the control. Anti-PRP GMTs were 7.1 mu g/mL for mpHBV-Hib and 8.0 mu g/mL for the control. Reactogenicity of the two vaccines was similar. Conclusions: The mpHBV in combination with Hib and with co-administered PCV was highly immunogenic. The safety profile of mpHBV-Hib was comparable to the licensed control. Both the control and mpHBV-Hib met acceptability criteria for seroprotection rates to hepatitis B, with higher anti-HBs GMTs noted for mpHBV-Hib. (C) 2011 Elsevier Ltd. All rights reserved.