Cadila Pharma gets CDSCO panel nod for Phase III CT Of Recombinant Rabies G Protein Vaccine

Approximately 55,000 human deaths caused by rabies are reported annually, with most of these cases occurring in developing countries. Stray dogs, wild carnivores, and bats are the natural reservoirs of field RABV, and these rabid carriers are a public health risk to humans and domestic animals.

For rabies prevention in domestic and wild animals, live attenuated rabies vaccines (strain SAD- and ERA-based modified live rabies vaccines) and recombinant rabies vaccines based on vaccinia viruses expressing RABV glycoprotein (G) (V-RG) have been developed.

During the past decade, a number of recombinant rabies vaccine candidates based on live attenuated RABV or recombinant viruses expressing RABV G have been developed as potential alternatives to current rabies vaccines.

Earlier, the Medical Dialogue Teams had reported that, regarding the Phase III clinical trial protocol for the recombinant Rabies G Protein Vaccine, the CDSCO panel had opined that Cadila Pharmaceutical should revise the protocol in accordance with the inclusion of safety. Accordingly, the expert panel had opined that the sample size should be increased and should be statistically significant for safety and immunogenicity.

After detailed deliberation, the committee recommended the grant of permission for the conduct of the Phase III clinical trial as per the presented revised protocol.