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Research Paper
An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax®) in Indian subjects
M.K. Sudarshan, S. Bhardwaj, B.J. Mahendra , H. Sharma , T.V. Sanjay , D.H. Ashwathnarayana and Gangaboraiah Bilagumba
volume 4 | issue 4
july/august 2008Pages: 275 - 279
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In 1999, Serum Institute of India indigenously developed an adsorbed human diploid cell rabies vaccine (Rabivax). During 2000 – 04, this new vaccine was subjected to a series of immunogenecity and safety studies. Initially, an experimental batch of Rabivax (adsorbed) was assessed on 10 healthy adult volunteers and its response was comparable with that of Merieux inactivated rabies vaccine (MIRV, lyophilized) which was used as a control. Subsequently, Rabivax (adsorbed) was assessed on forty-five suspect rabid dog bite cases with MIRV as control. The vaccine was found to be equally safe and immunogenic as MIRV and showed better rabies virus neutralizing antibody (RVNA) response on day 90 than MIRV. A post-licensing study conducted on 150 cases of suspect rabid animal bites showed it to be safe and immunogenic. To assess its long-term sero-efficacy some of these subjects tested after one year of follow up showed that 84% of them had adequate RVNA titers. In addition, a routine post-marketing surveillance done on 1608 animal bite cases demonstrated that Rabivax (adsorbed) was safe and efficacious. The adverse events to Rabivax (adsorbed) included pain at injection site (3.4%), swelling with induration (2.8%), fever and headache (1.4%). No serious adverse event was reported from the studies. In conclusion, Rabivax (adsorbed) is an immunogenic, safe, and efficacious vaccine for rabies prophylaxis in humans.
Authors
M.K. Sudarshan
Kempegowda Institute of Medical Sciences; Bangalore, India
S. Bhardwaj
Serum Institute of India; Pune, India
B.J. Mahendra
Department of Community Medicine; Mandya Institute of Medical Sciences; Mandya, India
H. Sharma
Serum Institute of India; Pune, India
T.V. Sanjay
Department of Community Medicine and Rabies; Epidemiology Unit; Kempegowda Institute of Medical Sciences; Bangalore, India
D.H. Ashwathnarayana
Department of Community Medicine and Rabies; Epidemiology Unit; Kempegowda Institute of Medical Sciences; Bangalore, India
Gangaboraiah Bilagumba
Department of Community Medicine and Rabies; Epidemiology Unit; Kempegowda Institute of Medical Sciences; Bangalore, India