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).

Comparison of Safety and Immunogenicity of PVRV and PCECV Immunized in Patients with WHO Category II Animal Exposure: A Study Based on Different Age Groups

“…Nowadays, China is in the midst of its third epidemic that begun in 1996 and peaked in 2007 (3300 cases), Wuhan, the largest city in the middle of China with about 10 million residents, has a medium incidence of rabies [4] . Although deadly, rabies can be prevented by timely initiation of post-exposure prophylaxis (PEP) which includes proper local treatment of bite wounds, administration of rabies vaccines either by intramuscular (IM) or intradermal (ID) route and local infiltration of rabies immunoglobulins (RIG) [5] . Due to high number of animal bites, there is a huge demand for rabies vaccines in developing countries of Asia and Africa [6] .…”

Utility of rabies neutralizing antibody detection in cerebrospinal fluid and serum for ante-mortem diagnosis of human rabies

“…CSF and serum samples were tested for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT), using a WHO recommended procedure [13] with some modifications as described earlier [14]. The antibody titers were expressed in International units (IU/ml) in comparison to an in house reference serum calibrated against 2nd International reference serum obtained from National Institute of Biological Standards, UK.…”

Serological Evidence ofLyssavirusInfection among Bats in Nagaland, a North-Eastern State in India

“…Sera were collected from 90 bats; only 78 were found to have adequate quantity to be processed for detection of rabies viral neutralizing antibodies (RVNA) using the RFFIT (rapid fluorescent focus inhibition test) according to the World Health Organization (WHO) recommended procedure [12] with some modifications [13]. Briefly, BHK 21 cell line (ATCC CCL 10) and BHK 21 adapted CVS 11 strain of virus were used and the tests were performed in 96 well-tissue culture plates.…”