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

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.

An assessment of rabies free status of the Island of Andaman, Nicobar and Lakshadweep: results of the WHO sponsored national multicentric rabies survey.

The Islands of Andaman and Nicobar and Lakshadweep have been reported to be rabies free from time immemorial. Recently, a survey of the islands of Andaman and Nicobar & Lakshadweep was done between July and August 2003 to assess their rabies free status. It was revealed that these islands continue to remain rabies free. However, in Andamans the increasing dog population, poor vigil on import of dogs and lack of laboratory surveillance for rabies posed a threat to this status. The Lakshadweep islands, which are free of dogs, however, faced a threat from the lack of vigil on the entry and presence of cats and poor surveillance for rabies in them.

Post exposure rabies prophylaxis with Purified Verocell Rabies Vaccine: a study of immunoresponse in pregnant women and their matched controls.

The present controlled clinical trial evaluates the immunoresponse to Purified Verocell Rabies Vaccnine (PVRV) by Essen schedule of vaccination during Pregnancy. Seventeen Pregnant women with history of animal bites who received PVRV as per Essen regimen were matched for the confounding variables of age, socio-economic status and doses of PVRV received with seventeen "Non-pregnant women". The mean age was about 24 years, majority (70.6%) belonging to middle socio-economic group and received 3 doses of PVRV. Contrary to the expectations the rabies neutralizing antibody titres were slightly higher in pregnant women (except day 180) but the difference was not significant (P > 0.2). Both the groups of women had antibody titres above protective level (0.5 IU/ml) from day 14 till day 365 thus indicating immunogenic efficacy of PVRV by Essen regimen during Pregnancy.