The mpHBV-Hib was compared with the licensed bivalent HBV-Hib vaccine Comvax?for immunogenicity and safety. Both vaccines contained 5 ¦Ìg/0.5 mL of hepatitis B surface antigen (HBsAg) and 7.5 ¦Ìg/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.
Seroprotection rates [ % subjects with anti-hepatitis B surface antigen antibody titers (anti-HBs) ?0 mIU/mL)] were 100 % and 99 % for mpHBV-Hib and the licensed control (Comvax?, 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 ?.15 ¦Ìg/mL and at ?.0 ¦Ìg/mL were 97 % and 94 % , respectively, for mpHBV-Hib and 96 % and 92 % , respectively, for the control. Anti-PRP GMTs were 7.1 ¦Ìg/mL for mpHBV-Hib and 8.0 ¦Ìg/mL for the control. Reactogenicity of the two vaccines was similar.
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.