Immunogenicity and safety of live attenuated hepatitis A vaccine: a multicentric study.
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Date
2009-01-31
Authors
Faridi, M M A
Shah, Nitin
Ghosh, T K
Sankaranarayanan, V S
Arankalle, Vidya
Aggarwal, Anju
Sathiyasekaran, Malathi
Bhattacharya, Nisha
Vasanthi, T
Chatterjee, Suparna
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Abstract
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.
CONCLUSION: 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.
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Faridi MM, Shah N, Ghosh TK, Sankaranarayanan VS, Arankalle V, Aggarwal A, Sathiyasekaran M, Bhattacharya N, Vasanthi T, Chatterjee S, Choudhury J, Mitra M. Immunogenicity and safety of live attenuated hepatitis A vaccine: a multicentric study. Indian Pediatrics. 2009 Jan; 46(1): 29-34