Immunogenicity, reactogenicity and consistency of a new, inactivated hepatitis A vaccine--a randomized multicentre study with three consecutive vaccine lots.
We investigated immunogenicity, reactogenicity and consistency of three consecutive lots of an inactivated hepatitis A vaccine in 204 seronegative volunteers. Each volunteer received a total of three doses of vaccine (720 EIU) according to a 0, 1 month primary vaccination schedule with a booster dose given at month 6. Mild, moderate and mostly local side effects were reported in 49.7% after the first and in less than 30% after the third injection. Seroconversion rate after one vaccine dose was as high as 91%. All subjects but one had already seroconverted by 1 month after the second injection, corresponding to a seroconversion rate of 99%. The geometric mean titres (GMT) increased with each dose of vaccine administered. Our results show that this inactivated hepatitis A vaccine is highly immunogenic, safe and well tolerated. Furthermore, there were no significant differences between the three vaccine lots in respect to seroconversion rate, size of antibody titre or reactogenicity.
Kallinowski
B
B
University Hospital of Heidelberg, Department of Internal Medicine IV, Germany.
Gmelin
K
K
Kommerell
B
B
Bock
H L
HL
Clemens
R
R
Scheiermann
N
N
Wohland
B
B
Hofmann
F
F
Theilmann
L
L
D000914:Antibodies, Viral / Q000032:analysis; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
D000914:Antibodies, Viral; D014765:Viral Vaccines