Safety and immunogenicity of a combined hepatitis A and hepatitis B vaccine in young healthy adults.
BACKGROUND
A combination of hepatitis A and hepatitis B monovalent vaccines could offer advantages for disease control programs in terms of convenience, compliance and cost.


METHODS
Under randomized, double-blind conditions, 156 healthy young adults were divided into 3 groups to receive 1 of 3 lots of a combined hepatitis A/hepatitis B vaccine administered at months 0, 1, and 6. Safety and immunogenicity were assessed after each dose.


RESULTS
Transient and predominantly mild reactions were reported by slightly more than half the vaccinees; no serious adverse effects were relate to vaccination. One month after dose 2, all subjects had converted to the hepatitis A component. Geometric mean titers (GMTs) of antibodies of hepatitis A virus varied from 4415 to 4882 mIU/ml in the three groups. For hepatitis B, most vaccinees (73%-92%) had protective levels of antibodies to hepatitis B virus (anti-HBs) after the second dose, and all were sero-protected after the booster. Anti-HBs GMTs at month 7 ranged from 1917 to 3298 mIU/ml.


CONCLUSIONS
No statistically significant differences were observed between vaccine lots. The combined hepatitis A/hepatitis B vaccine was safe and clinically well tolerated and induced immune responses quantitatively similar to those obtained with the respective monovalent vaccines.
Dept. of Clinical Chemistry, Microbiology and Immunology, University of Gent, Belgium.
G
G
Leroux-Roels
W
W
Moreau
I
I
Desombere
A
A
Safary
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007109:Immunity; D008297:Male; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage*; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage
D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; D014761:Viral Hepatitis Vaccines