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Journal of Tropical Pediatrics Advance Access originally published online on May 3, 2007
Journal of Tropical Pediatrics 2007 53(5):303-307; doi:10.1093/tropej/fmm016
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© The Author [2007]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Immunogenicity and Reactogenicity of Two Recombinant Hepatitis B Vaccines in Small Infants: A Randomized, Double-Blind Comparative Study

Amita Saprua, P. S. Kulkarnib, Sheila Bhavea, Ashish Bavdekara, S. S. Naika and Anand N. Pandita

aKing Edward Memorial Hospital & Research Centre, Pune, India
bSerum Institute of India Ltd. Pune, India

Correspondence: P. S. Kulkarni Deputy Medical Director, Serum Institute of India Ltd., 212/2, Hadapsar, Pune 411028, India. Tel: 91-2026602384, Fax: 91-20-26993945. E-mail < drpsk{at}seruminstitute.com>.


  Abstract

Hepatitis B infection is very common in infants, especially in countries with limited resources. Hepatitis B vaccination is recommended in the routine immunization schedules in many countries, including India. We compared immunogenicity and reactogenicity of two recombinant hepatitis B (HB) vaccines in healthy infants. A total of 262 evaluable Indian infants received three doses of 10 µg of an Indian (GeneVac-B®) or European (Engerix-B®) HB vaccine in a double-blind, randomized fashion. The first dose, given at birth, was followed by a dose at age 6 and 14 weeks. All the subjects were initially seronegative for HB surface antigen (HBsAg) and anti-HB antibodies (anti-HBs). The post-vaccination anti-HBs titers were assessed by ELISA at the time of second and third dose, and 1 month after the third dose. Seroconversion and seroprotection were defined as anti-HBs titers ≥1 mIU/ml and ≥10 mIU/ml, respectively. After first dose, the seroconversion rates were 20% and 17%, in Indian and European vaccine recipients, respectively. The second and third dose increased the seroconversion to 84% and 80%, and to 98% and 98%, respectively. Correspondingly, the seroprotection rates after the first dose was 11% and 10%, and consequently 54% and 58%, and 97% and 95%. None of the differences between vaccines reached statistically significant proportions. Geometric Mean Titer after third dose was 383 mIU/ml and 285 mIU/ml, respectively, also this difference remaining insignificant. Adverse events were similar in both vaccine groups. Immunogenicity and reactogenicity of the Indian and European Hepatitis B vaccines were comparable, when immunization was started at birth.


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