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

Abstract: 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™ for immunogenicity and safety. Both vaccines contained 5μg/0.5mL of hepatitis B surface antigen (HBsAg) and 7.5μg/0.5mL 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) ≥10mIU/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 ≥0.15μg/mL and at ≥1.0μg/mL were 97% and 94%, respectively, for mpHBV–Hib and 96% and 92%, respectively, for the control. Anti-PRP GMTs were 7.1μg/mL for mpHBV–Hib and 8.0μg/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. [Copyright &y& Elsevier]