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Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India.
Hum Vaccin Immunother. 2014; 10(1):120-5.HV

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 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).

Authors+Show Affiliations

Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India.Institute of Preventive Medicine; Hyderabad, India.Department of Community Medicine; MKCG Medical College; Berhampur, India.Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Community Medicine; MKCG Medical College; Berhampur, India.Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India.Department of Community Medicine; MKCG Medical College; Berhampur, India.Medical Services; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India.Vaccine Manufacturing; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

24030586

Citation

Ashwath Narayana, Doddabele Hanumanthaiah, et al. "Safety and Immunogenicity Study of a New Purified Chick Embryo Cell Rabies Vaccine Vaxirab-N (Pitman-Moore Strain) Manufactured in India." Human Vaccines & Immunotherapeutics, vol. 10, no. 1, 2014, pp. 120-5.
Ashwath Narayana DH, Madhusudana SN, Sampath G, et al. Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. Hum Vaccin Immunother. 2014;10(1):120-5.
Ashwath Narayana, D. H., Madhusudana, S. N., Sampath, G., Tripathy, R. M., Sudarshan, M. K., Gangaboraiah, ., Ravish, H. S., Satapathy, D. M., Gowda, G., Holla, R., Ashwin, B. Y., Padhi, A., Manjula, S., & 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 & Immunotherapeutics, 10(1), 120-5. https://doi.org/10.4161/hv.26456
Ashwath Narayana DH, et al. Safety and Immunogenicity Study of a New Purified Chick Embryo Cell Rabies Vaccine Vaxirab-N (Pitman-Moore Strain) Manufactured in India. Hum Vaccin Immunother. 2014;10(1):120-5. PubMed PMID: 24030586.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. AU - Ashwath Narayana,Doddabele Hanumanthaiah, AU - Madhusudana,Shampur Narayana, AU - Sampath,Gadey, AU - Tripathy,Radhe Madhab, AU - Sudarshan,Mysore Kalappa, AU - Gangaboraiah,, AU - Ravish,Haradanahalli Shankaraiah, AU - Satapathy,Durga Madhab, AU - Gowda,Giriyanna, AU - Holla,Ramesh, AU - Ashwin,Belludi Yajman, AU - Padhi,Asutosh, AU - Manjula,Shamanna, AU - Patel,Pradip Maganlal, Y1 - 2013/09/12/ PY - 2013/9/14/entrez PY - 2013/9/14/pubmed PY - 2015/1/6/medline KW - PCEC vaccine KW - Pitman–Moore strain KW - clinical trials KW - post-exposure prophylaxis KW - rabies KW - rabies vaccines SP - 120 EP - 5 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 1 N2 - 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). SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/24030586/Safety_and_immunogenicity_study_of_a_new_purified_chick_embryo_cell_rabies_vaccine_Vaxirab_N__Pitman_Moore_strain__manufactured_in_India_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.26456 DB - PRIME DP - Unbound Medicine ER -