Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine maker Cadila Pharmaceuticals that Phase III clinical trial protocol for the Recombinant Rabies G Protein Vaccine should be revised for inclusion of safety as study objectives and accordingly sample size should be increased and should be statistically significant for safety & immunogenicity.
This came after the firm presented its proposal for a grant of permission to conduct Phase III clinical trial in the pediatric population in the age group of 1 year to <18 years.
Rabies virus (RABV) infection leads to rabies in warm-blooded animals, including humans, and is characterized by acute encephalitis at 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.
At the recent SEC meeting for vaccines held on 21 November 2022, the expert panel reviewed the proposal for a grant of permission to conduct a Phase III clinical trial in the pediatric population in the age group of 1 year to <18 years.
