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, Shampur Narayana Madhusudana, Gadey Sampath, Radhe Madhab Tripathy, Mysore Kalappa Sudarshan, Gangaboraiah, Haradanahalli Shankaraiah Ravish, Durga Madhab Satapathy, Giriyanna Gowda, Ramesh Holla, Belludi Yajman Ashwin, Asutosh Padhi, Shamanna Manjula, Pradip Maganlal Patel

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Abstract

Zydus Cadila Health care, India developed a new purified chick embryo cell rabies vaccine (PCECV, 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 post-exposure 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).

Original languageEnglish
Pages (from-to)2796-2801
Number of pages6
JournalHuman Vaccines and Immunotherapeutics
Volume10
Issue number1
DOIs
Publication statusPublished - 01-01-2014

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All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Ashwath Narayana, D. H., Madhusudana, S. N., Sampath, G., Tripathy, R. M., Sudarshan, M. K., Gangaboraiah, ... Patel, P. M. (2014). Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. Human Vaccines and Immunotherapeutics, 10(1), 2796-2801. https://doi.org/10.4161/hv.26456