Cadila Pharma gets CDSCO panel nod for Phase III CT Of Recombinant Rabies G Protein Vaccine
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Cadila Pharmaceutical to conduct a Phase III clinical trial of the recombinant Rabies G Protein Vaccine in the paediatric population in the age group of 1 year to <18 years.
This came after the firm presented its proposal for a grant of permission to conduct Phase III clinical trial of Recombinant Rabies G Protein Vaccine in the pediatric population in the age group of 1 year to <18 years.
Rabies is a viral disease that causes encephalitis in humans and other mammals. Early symptoms include fever and tingling at the site of exposure. These symptoms are followed by one or more of the following: nausea, vomiting, violent movements, uncontrolled excitement, fear of water, an inability to move parts of the body, confusion, and loss of consciousness.
Rabies virus (RABV) infection leads to rabies in warm-blooded animals, including humans, and is characterized by acute encephalitis in the early phase and fatality at the later stage without postexposure treatment.
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.
Now, in continuation, at the recent SEC meeting for vaccines dated January 24, 2023, the expert panel reviewed the proposal presented by the firm to conduct a Phase III clinical trial of the recombinant Rabies G protein vaccine in the paediatric population in the age group of 1 year to <18 years.
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.
