Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India

Doddabele, Hanumanthaiah Ashwath Narayana and Shampur , Narayana Madhusudana and Gadey , Sampath and Tripathy, Radhe Madhab and Mysore , Kalappa Sudarshan and *, Gangaboraiah and Haradanahalli , Shankaraiah Ravish and Satapathy, Durga Madhab and Gowda, Giriyanna and Holla, Ramesh and Belludi , Yajman Ashwin and Padhi, Asutosh and *, Shamanna Manjula and Patel, Pradip Maganlal (2014) Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. Human Vaccines & Immunotherapeutics, 10 (1). pp. 2796-2801.

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Abstract

Zydus Cadila Health care, India developed a new purified chick embryo cell rabies vaccine (PCEC V, Vaxirab-N; 1 mL) by adapting Pitman-Moore strain of virus on to the chick embryo fibroblast cell line in 2006. During 2007–10, a series of safety and immunogenicity studies were conducted as per ICH-GCP guidelines after obtaining permission from Drug Controller General of India. In the first study, Vaxirab-N was administered to 35 healthy adult volunteers by intramuscular (IM) route using pre exposure regimen. The geometric mean concentration (GMC) of rabies virus neutralizing antibody (RvnAb) of 7.5 IU/mL on day 35. In the 2nd study, Vaxirab-N was administered to 35 healthy adult volunteers using simulated post- exposure prophylaxis regimen by IM route. A GMC of 6.3 IU/mL on day 14, 13.2 IU/mL on day 28 and 8.6 IU/mL on day 90 was obtained. In the 3rd study, Vaxirab-N administered by intradermal (ID) route using Updated Thai Red Cross (TRC) regimen in 36 healthy adult volunteers showed GMC of 7.8 IU/mL on day 14, 11.5 IU/mL on day 28 and 6.0 IU/mL on day 90. The 4th study was multi centric and Vaxirab-N was administered to 129 animal bite cases by IM route using postexposure Essen regimen. The GMC following this schedule was 8.2 IU/mL on day 14, 13.01 IU/mL on day 28, 7.92 IU/mL on day 90 and 3.72 IU/mL on day 180. Mild to moderate adverse events were reported to Vaxirab-N but no serious adverse events were reported in any of these studies. In conclusion, Vaxirab-N developed by Zydus Cadila was found to be safe and immunogenic by both intramuscular and intradermal route and is recommended for rabies prophylaxis (CTRI No. 2010/091/000055 and 2010/091/000509).

Item Type: Article
Uncontrolled Keywords: rabies, post-exposure prophylaxis, PCEC vaccine, clinical trials, Pitman-Moore strain, rabies vaccines
Subjects: Medicine > KMC Mangalore > Community Medicine
Depositing User: KMCMLR User
Date Deposited: 08 Mar 2014 07:01
Last Modified: 08 Mar 2014 07:01
URI: http://eprints.manipal.edu/id/eprint/139051

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