Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children
Authors Bhave S, Ghosh A, Sapru A, Mitra M, Chatterjee S, Bhattacharya N, Kadhe G, Mane A, Roy S
Received 9 August 2013
Accepted for publication 20 September 2013
Published 19 December 2013 Volume 2014:4 Pages 1—6
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Sheila Bhave,1 Apurba Ghosh,2 Amita Sapru,1 Monjori Mitra,2 Suparna Chatterjee,3 Nisha Bhattacharya,2 Ganesh Kadhe,4 Amey Mane,4 Sucheta Roy4
1Department of Pediatrics, KEM Hospital Research Centre, Pune, Maharashtra, India; 2Department of Pediatrics, Institute of Child Health, Kolkata, West Bengal, India; 3Institute of Post Graduate Medical Education & Research, Kolkata, West Bengal, India; 4Medical Affairs Department, Wockhardt Ltd, Mumbai, India
Introduction: The World Health Organization (WHO) recommends either inactivated or live attenuated vaccine against the hepatitis A virus (HAV) infection in countries with high incidence. Live attenuated vaccines against HAV infection have been developed and used exclusively in the People’s Republic of China and have shown promising results. This is the first study conducted outside the People’s Republic of China to evaluate the immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children.
Material and methods: This was an open-labeled, 8-week (July 2012 to October 2012), non-comparative, non-randomized, confirmatory study conducted at two centers (Kolkata and Pune) in India. A total of 140 healthy Indian children aged 12 months to 12 years were administered live attenuated hepatitis A vaccine at the two centers. Overall, 137 subjects (female: 66, mean age: 4.09±2.5 years) completed the study. The subjects were vaccinated (subcutaneous over the deltoid muscle of the upper arm) with 0.5 mL of live attenuated H2 strain hepatitis A vaccine.
Results: Eight weeks after a single dose of the vaccine, 136 subjects from both the centers developed protective immunoglobulin (IgM) G antibodies ≥20 mIU/mL. The overall seroconversion rate was 99% (Kolkata: 100%, Pune: 98%). The hematological and biochemical parameters remained within normal limits. All the adverse events were non-serious and mild in severity.
Conclusion: Live attenuated H2 strain hepatitis A vaccine is immunogenic and safe in Indian children.
Keywords: hepatitis A, children, live attenuated vaccine, seroconversion
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