Safety and Immunogenicity of a Modified Process Hepatitis B Vaccine in Healthy Infants

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Pediatr Infect Dis J. 2011 May 5. [Epub ahead of print]

Safety and Immunogenicity of a Modified Process Hepatitis B Vaccine in Healthy

Infants.

Vesikari T, JC, Liss CL, Liska V, Schödel FP, Bhuyan PK.

Source

From the *Vaccine Research Center, University of Tampere Medical School,

Tampere, Finland, and †Merck & Co., Inc., Whitehouse Station, NJ.

Abstract

BACKGROUND:

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.

METHODS:

In a randomized, double-blind study, healthy infants (N = 1718), approximately 2

months of age, received a 0.5-mL intramuscular dose of 5-μg mpHBV,

Recombivax-HB (5 μg), 10-μg mpHBV, or Engerix-B (10 μg) at day 1, month 2,

and month 4 (2, 4, 6 months of age). Serum antibody to hepatitis B surface

antigen (anti-HBs) was analyzed at month 7. The geometric mean titer (GMT) and

seroprotection rate (SPR; % subjects with anti-HBs titer ≥10 mIU/mL) were

determined 1 month after the third dose.

RESULTS:

Month 7 SPRs were 99.3% (402/405, 95% confidence interval [CI]: 98.3, 100) in

the 5 μg mpHBV group, 100.0% (398/398, 95% CI: 99.9, 100) in the 10 μg mpHBV

group, 98.5% (400/406, 95% CI: 97.2, 99.8) in the Recombivax-HB group, and 99.5%

(398/400, 95% CI: 98.7, 100) in the Engerix-B group. Month 7 GMTs (mIU/mL) were

748.2 (95% CI: 672.0, 833.1) in the 5 μg mpHBV group, 981.5 (95% CI: 891.0,

1081.2) in the 10 μg mpHBV group, 376.8 (95% CI: 331.4, 428.5) in the

Recombivax-HB group, and 556.6 (95% CI: 491.8, 629.9) in the Engerix-B group.

The percentages of subjects reporting injection-site or systemic adverse events

were similar across the vaccination groups.

CONCLUSIONS:

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.

PMID: 21552183 [PubMed - as supplied by publisher]