Immunogenicity and safety of live attenuated hepatitis A vaccine: a multicentric study.
OBJECTIVE
To evaluate immunogenicity and tolerability of single dose live attenuated injectable hepatitis A vaccine in four metropolitan cities of India.


METHODS
Live attenuated hepatitis A vaccine was administered to 505 children aged 18 to 60 months in four centers across India. Immunogenicity of the vaccine was assessed by estimation of anti-HAV antibody titer at 6 weeks and 6 months following administration of the vaccine. Safety evaluation of the vaccine was also done during the visits.


RESULTS
At 6 weeks, 480 subjects (95%) came for the follow-up and 411 (81.4%) subjects reported at the end of 6 months. The geometric mean titer (GMT) of anti-HAV antibody of the subjects who did not have the seroprotective titer at the baseline were assessed at 6 weeks and 6 months which was 81.04 mIU/ml and 150.66 mIU/ml respectively. At 6 weeks, 95.1 % seroconverted and at the end of 6 months, 97.9 % had seroconverted. Both solicited and unsolicited vaccine-induced local and systemic adverse events were insignificant at all the centers, except swelling and induration in a few.


CONCLUSIONS
Live attenuated injectable hepatitis A vaccine was immunogenic and tolerable with minimal reactogenecity, in this study of single dose schedule. Safety profile was also satisfactory in the study population.
Faridi
M M A
MM
Department of Pediatrics, University College of Medical Sciences, New Delhi.
Shah
Nitin
N
Ghosh
T K
TK
Sankaranarayanan
V S
VS
Arankalle
Vidya
V
Aggarwal
Anju
A
Sathiyasekaran
Malathi
M
Bhattacharya
Nisha
N
Vasanthi
T
T
Chatterjee
Suparna
S
Choudhury
Jaydeep
J
Mitra
Monjori
M
D002675:Child, Preschool; D005260:Female; D006506:Hepatitis A / Q000517:prevention & control*; D035922:Hepatitis A Antibodies / Q000032:analysis / Q000276:immunology; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D007223:Infant; D008297:Male
D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines