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

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

Infants

The Pediatric Infectious Disease Journal, 06/30/2011

Vesikari T et al. – All 4 hepatitis B vaccines elicited high hepatitis B

surface antigen(anti–HBs) seroprotection rate(SPRs). After dose 3, anti–HBs

geometric mean titer(GMT) were highest in the 10 μg mpHBV group, but did not

meet the predefined criteria for superiority. All vaccines were well tolerated.

Methods

• 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) in a

randomized, double-blind study.

• Serum antibody to hepatitis B surface antigen (anti-HBs) was analyzed at

month 7.

• 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 ?g 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.

• Percentages of subjects reporting injection-site or systemic adverse events

were similar across the vaccination groups.

___________________________________________________________________________

http://journals.lww.com/pidj/Abstract/2011/07000/Safety_and_Immunogenicity_of_a_\

Modified_Process.31.aspx

Pediatric Infectious Disease Journal:

July 2011 - Volume 30 - Issue 7 - pp e109-e113

doi: 10.1097/INF.0b013e31821ed1a4

Online-Only: Original Studies

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

Infants

Vesikari, Timo MD*; , C. MS†; Liss, L. MS†; Liska,

Vladimir PhD†; Schödel, Florian P. MD†; Bhuyan, Prakash K. MD, PhD†

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.

© 2011 Lippincott & Wilkins, Inc.