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

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Vaccine. 2011 Aug 26. [Epub ahead of print]

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.

Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schödel FP, Bhuyan PK.

Source

Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.

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 Comvaxâ„¢

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 (Comvaxâ„¢), 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 © 2011. Published by Elsevier Ltd.

PMID: 21875633 [PubMed - as supplied by publisher]