| Autor: |
Ashwath Narayana DH; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Madhusudana SN; Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India., Sampath G; Institute of Preventive Medicine; Hyderabad, India., Tripathy RM; Department of Community Medicine; MKCG Medical College; Berhampur, India., Sudarshan MK; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Gangaboraiah; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Ravish HS; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Satapathy DM; Department of Community Medicine; MKCG Medical College; Berhampur, India., Gowda G; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Holla R; Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India., Ashwin BY; Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India., Padhi A; Department of Community Medicine; MKCG Medical College; Berhampur, India., Manjula S; Medical Services; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India., Patel PM; Vaccine Manufacturing; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India. |
| Abstrakt: |
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 second 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 third 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). |
