Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila

Published On 2022-12-04 08:14 GMT | Update On 2024-02-14 04:17 GMT

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...

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.

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 virus 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.

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.

After detailed deliberation, the committee recommended that the Phase III clinical trial protocol should be revised for the inclusion of safety as the study objective and accordingly sample size should be increased and should be statistically significant for safety & immunogenicity.

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila

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