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

Research output: Contribution to journalArticle

10 Citations (Scopus)

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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Rabies Vaccines
Chick Embryo
India
Healthy Volunteers
Safety
Post-Exposure Prophylaxis
Red Cross
Rabies virus
Rabies
Bites and Stings
Neutralizing Antibodies
Appointments and Schedules
Fibroblasts
Guidelines
Viruses
Delivery of Health Care
Cell Line
Pharmaceutical Preparations

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
Ashwath Narayana, Doddabele Hanumanthaiah ; Madhusudana, Shampur Narayana ; Sampath, Gadey ; Tripathy, Radhe Madhab ; Sudarshan, Mysore Kalappa ; Gangaboraiah ; Ravish, Haradanahalli Shankaraiah ; Satapathy, Durga Madhab ; Gowda, Giriyanna ; Holla, Ramesh ; Ashwin, Belludi Yajman ; Padhi, Asutosh ; Manjula, Shamanna ; Patel, Pradip Maganlal. / Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India. In: Human Vaccines and Immunotherapeutics. 2014 ; Vol. 10, No. 1. pp. 2796-2801.
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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).",
author = "{Ashwath Narayana}, {Doddabele Hanumanthaiah} and Madhusudana, {Shampur Narayana} and Gadey Sampath and Tripathy, {Radhe Madhab} and Sudarshan, {Mysore Kalappa} and Gangaboraiah and Ravish, {Haradanahalli Shankaraiah} and Satapathy, {Durga Madhab} and Giriyanna Gowda and Ramesh Holla and Ashwin, {Belludi Yajman} and Asutosh Padhi and Shamanna Manjula and Patel, {Pradip Maganlal}",
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Ashwath Narayana, DH, Madhusudana, SN, Sampath, G, Tripathy, RM, Sudarshan, MK, Gangaboraiah, Ravish, HS, Satapathy, DM, Gowda, G, Holla, R, Ashwin, BY, Padhi, A, Manjula, S & Patel, PM 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, vol. 10, no. 1, pp. 2796-2801. https://doi.org/10.4161/hv.26456

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

In: Human Vaccines and Immunotherapeutics, Vol. 10, No. 1, 01.01.2014, p. 2796-2801.

Research output: Contribution to journalArticle

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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

PY - 2014/1/1

Y1 - 2014/1/1

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 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).

AB - 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).

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