title: An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax) in Indian subjects.
abstract: 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.
authors.affiliation: Department of Community Medicine and Rabies, Epidemiology Unit, Kempegowda Institute of Medical Sciences, Bangalore, India. mksudarshan@vsnl.com
authors.forename: M K
authors.initials: MK
authors.lastname: Sudarshan
authors.forename: S
authors.initials: S
authors.lastname: Bhardwaj
authors.forename: B J
authors.initials: BJ
authors.lastname: Mahendra
authors.forename: H
authors.initials: H
authors.lastname: Sharma
authors.forename: T V
authors.initials: TV
authors.lastname: Sanjay
authors.forename: D H
authors.initials: DH
authors.lastname: Ashwathnarayana
authors.forename: Gangaboraiah
authors.initials: G
authors.lastname: Bilagumba
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D001733:Bites and Stings; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004171:Diploidy; D004285:Dogs; D004487:Edema / Q000276:immunology; D005260:Female; D005334:Fever / Q000276:immunology; D006261:Headache / Q000276:immunology; D006801:Humans; D007194:India; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D010146:Pain / Q000276:immunology; D011358:Product Surveillance, Postmarketing; D011818:Rabies / Q000276:immunology / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011820:Rabies virus / Q000276:immunology; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects
chemical_list: D000914:Antibodies, Viral; D011819:Rabies Vaccines; C532964:rabivax