Immunogenicity and reactogenicity of an inactivated hepatitis A vaccine in Indian adults.
BACKGROUND
In India, a possible decrease in the prevalence of anti-HAV (hepatitis A virus) antibodies in adults has increased their susceptibility to HAV infection. We evaluated the immunogenicity and reactogenicity of an inactivated hepatitis A vaccine administered in a 3-injection protocol.


METHODS
Thirty-five healthy adult volunteers, seronegative for anti-HAV IgG, were administered 720 ELISA units/ml of the inactivated hepatitis A vaccine intramuscularly at days 0, 30 and 180. Anti-HAV IgG was determined at days 30, 60, 90 and 180 to assess the efficacy of the vaccine and adverse reactions were noted to evaluate its reactogenicity.


RESULTS
The mean (SD) age of the volunteers was 33.1 (12.3) years and the man:woman ratio was 19:16. An overall seroprotection of 37.2% (13/35) was obtained at day 30, 57.1% (20/35) at day 60 and 85.7% (30/35) at day 90. By day 180, all the vaccinees (35/35; 100%) achieved protective seroconversion. The vaccine in general was well tolerated and no serious side-effects were observed. Only 8.6% (3/35) of subjects developed minor self-resolving adverse reactions such as local pain, erythema and/or low-grade fever.


CONCLUSIONS
The inactivated hepatitis A vaccine in a three-injection protocol (0, 30 and 120 days) is safe, well tolerated and highly immunogenic in adult Indian subjects.
Das
K
K
Department of Medicine, Maulana Azad Medical College, Bahadurshah Zafar Marg, New Delhi, India.
Jain
A
A
Gupta
R K
RK
Kar
P
P
D000293:Adolescent; D000328:Adult; D005260:Female; D006506:Hepatitis A / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies / Q000097:blood; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies; D014761:Viral Hepatitis Vaccines