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.

Safety, immunogenicity and clinical efficacy of post exposure prophylaxis in confirmed rabies exposures

“…Therefore, the demand for a safe and effective cell culture vaccines and rabies immunoglobulin for PEP is ever increasing. In this context, many pharmaceutical companies have started production and the availability of these newer vaccines and immunoglobulins for PEP are always present in the market [6][7][8][9][10][11]. Therefore, the safety and efficacy of these rabies immune biologicals should be established periodically.…”

Characteristics and viral propagation properties of a new human diploid cell line, walvax-2, and its suitability as a candidate cell substrate for vaccine production

“…To minimize costs as well as make it affordable for Indians, the Serum Institute of India indigenously developed Ravivax ( Pitman-Moore strain, MRC-5), decreasing the cost for the vaccine dramatically (from US $40 dropped to $7). 20 This is also one of the motivations for this study, to develop a totally new HDCS that could be used as a culture medium in manufacturing viral vaccines in China. Recently, a document from the Chinese pharmacopeia commission indicates that the current 2 kinds of cell substrate rabies vaccine presently on the international market, PVRV and PHK, may not be included in the updated Chinese pharmacopeia (2015).…”

“…The sensitivity to rabies virus of Walvax-2 has important implications for China. Human diploid cell rabies vaccine, which is free of complications but is highly immunogenic, 20 is considered to be the gold standard for rabies vaccine. 16 According to the report by the WHO, there are roughly 55000 human deaths caused by rabies annually.…”

Human health implications of emerging diseases and the current situation in India's vaccine industry

“… Abhayrab & AbhayRIG (Indian Immunologicals Limited, India), Rabipur® (Sanofi Aventis), Verorab (Zydus Cadila Health Care Ltd), Equirab & Berirab P (Bharat Serums & Vaccines Ltd.) Tegretol, Sprycel, Purinethol, Chlormethine, Yondelis, Gemzar, Leukeran (GSK, novartis pharmaceutical company, Bristol-myers squibb company, Janssen biotech, inc) Asia and Africa Raccoons, skunks, bats, and foxes. [ 57 , 58 ] Hepatitis (Hepatitis virus) Sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth Engerix-B, Heplisav-B, and Recombivax HB, Revac-B mcf, Hepabig – VHB (Bharat Biotech, Dynavax, Serum Institute of India). Elovac-B & Vaxtar-5™ (Indian Immunologicals Limited, India) Entecavir (Schwitz Biotech), Tenofovir (Gilead Sciences, Inc.), Lamivudine (Anant Pharmaceuticals Pvt.…”