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.
RCT Entities:
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.
Authors: Pierre Van Damme; Geert Leroux-Roels; P Suryakiran; Nicolas Folschweiller; Olivier Van Der Meeren Journal: Hum Vaccin Immunother Date: 2017-03-10 Impact factor: 3.452