title: Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India.
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.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.forename: Doddabele Hanumanthaiah
authors.initials: DH
authors.lastname: Ashwath Narayana
authors.affiliation: Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India.
authors.forename: Shampur Narayana
authors.initials: SN
authors.lastname: Madhusudana
authors.affiliation: Institute of Preventive Medicine; Hyderabad, India.
authors.forename: Gadey
authors.initials: G
authors.lastname: Sampath
authors.affiliation: Department of Community Medicine; MKCG Medical College; Berhampur, India.
authors.forename: Radhe Madhab
authors.initials: RM
authors.lastname: Tripathy
authors.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.forename: Mysore Kalappa
authors.initials: MK
authors.lastname: Sudarshan
authors.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.lastname: Gangaboraiah
authors.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.forename: Haradanahalli Shankaraiah
authors.initials: HS
authors.lastname: Ravish
authors.affiliation: Department of Community Medicine; MKCG Medical College; Berhampur, India.
authors.forename: Durga Madhab
authors.initials: DM
authors.lastname: Satapathy
authors.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.forename: Giriyanna
authors.initials: G
authors.lastname: Gowda
authors.affiliation: Department of Community Medicine; Kempegowda Institute of Medical Sciences (KIMS); Bangalore, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Holla
authors.affiliation: Department of Neurovirology; National Institute of Mental Health and Neurosciences (NIMHANS); Bangalore, India.
authors.forename: Belludi Yajman
authors.initials: BY
authors.lastname: Ashwin
authors.affiliation: Department of Community Medicine; MKCG Medical College; Berhampur, India.
authors.forename: Asutosh
authors.initials: A
authors.lastname: Padhi
authors.affiliation: Medical Services; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India.
authors.forename: Shamanna
authors.initials: S
authors.lastname: Manjula
authors.affiliation: Vaccine Manufacturing; Zydus Cadila Health care Pvt. Ltd; Ahmedabad, India.
authors.forename: Pradip Maganlal
authors.initials: PM
authors.lastname: Patel
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002460:Cell Line; D002642:Chick Embryo; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D005347:Fibroblasts / Q000821:virology; D006801:Humans; D007194:India; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D019590:Nucleocapsid Proteins / Q000276:immunology*; D056990:Post-Exposure Prophylaxis / Q000379:methods; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000302:isolation & purification; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D019590:Nucleocapsid Proteins; D011819:Rabies Vaccines; C099601:nucleocapsid protein, Rabies virus
keywords: PCEC vaccine; Pitman–Moore strain; clinical trials; post-exposure prophylaxis; rabies; rabies vaccines
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