An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax (R)) in Indian subjects

作者：Sudarshan M K^*; Bhardwaj S; Mahendra B J; Sharma H; Sanjay T V; Ashwathnarayana D H; Bilagumba Gangaboraiah

来源：Human Vaccines, 2008, 4(4): 275-279.

• Rabivax (adsorbed)
• human diploid cell rabies vaccine
• cell culture rabies vaccine
• rabies in India

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 ten 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.

• 出版日期2008-8
• 单位河北医科大学