Purified chick-embryo-cell (PCEC) rabies vaccine: its potency performance in different test systems and in humans

Barth, R; Franke, V.; Müller, H; Weinmann, E.

doi:10.1016/0264-410x(90)90176-m

Cited by 16 publications

(5 citation statements)

References 6 publications

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“…Indeed some earlier studies have shown that Rabipur produced greater RvnAb response and greater protection in animal experiments when homologous virus was used as a challenge virus. 16,17 In spite of these observations, Rabipur has been found to be efficacious in preventing rabies in exposed individuals both by conventional IM and the ID routes of vaccination This new PCEC vaccine (Vaxirab-N) has been produced after successful adaptation of Pitman-Moore strain of rabies virus. The genetic stability of the strain was maintained during the adaptation procedure.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman–Moore strain) manufactured in India

Narayana

Madhusudana

Sampath

et al. 2013

Human Vaccines & Immunotherapeutics

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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).

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Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman–Moore strain) manufactured in India

Narayana

Madhusudana

Sampath

et al. 2013

Human Vaccines & Immunotherapeutics

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“…This has, however, led to only limited numbers of proposals for actual replacement. So far, the modified antibody binding test (ABT) (Barth et al, 1981;Barth et al, 1990) and the single radial diffusion test (SRD) (Ferguson and Schild, 1982;Ferguson et al, 1984;Ferguson and Heath, 1992) were proposed as alternatives. Their use is restricted to GP measurement by polyclonal antibodies and is not applicable to adjuvanted vaccines.…”

Section: Discussionmentioning

confidence: 99%

Rabies vaccine potency control: comparison of ELISA systems for antigenicity testing

Rooijakkers

Uittenbogaard

Groen

et al. 1996

Journal of Virological Methods

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Potency control of inactivated rabies vaccines for human and veterinary application is usually undertaken by vaccination-challenge tests (e.g. the mouse potency test). For practical and ethical reasons there is an urgent need to replace in vivo potency control procedures, at least in part, by reliable methods of in vitro potency testing. Quantitative ELISA systems for potency control were developed using monoclonal antibodies (MAbs) directed to the glycoprotein (GP) and to the nucleoprotein (NP) of the virus. Although immuno-capture and competition ELISAs for GP measurement had almost equal sensitivity (detection level GP < 0.1 IU), the competition data showed the best correlation with potency values when a panel of rabies vaccines for human use was tested (r = 0.88, n = 10). The NP values for this panel of vaccines in the competition system (detection level NP < 1 IU) also correlated well with potency values (r = 0.90, n = 10). The competition system proved to be best also with liquid adjuvanted veterinary rabies vaccines of LEP, PM, PV and SAD origin. The implementation of ELISA systems for potency control of rabies vaccines is discussed.

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“…Because of the variations observed in the outcome of mouse potency tests, but also for practical and ethical reasons, alternative methods for potency control should be sought. To date, limited information is available on possible alternatives for the actual replacement of the mouse potency test (2,3,10,11) that would be independent of laboratory animal use, which causes most of the aforementioned problems. The alternative in vitro methods that have been considered include the modified antibody binding test (4,5), the single radial immuno-diffusion test (12,13), and ELISAs (1, 21,22,23,29,31).…”

Section: Discussionmentioning

confidence: 99%

Potency of veterinary rabies vaccines in the Netherlands: A case for continued vigilance

Rooijakkers

Nieuwenhuijs

Vermeulen

et al. 1996

Veterinary Quarterly

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Purified chick-embryo-cell (PCEC) rabies vaccine: its potency performance in different test systems and in humans

Cited by 16 publications

References 6 publications

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman–Moore strain) manufactured in India

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman–Moore strain) manufactured in India

Rabies vaccine potency control: comparison of ELISA systems for antigenicity testing

Potency of veterinary rabies vaccines in the Netherlands: A case for continued vigilance

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