SEC Recommends Permission For Phase I Trial Of Cadila Pharma’s VZV Vaccine

New Delhi : The Subject Expert Committee (SEC) on vaccines, which reviews proposals and advice the Drugs Controller General (India) (DCGI) in matters for biologicals and post approval change proposals, has recommended to grant permission to Gujarat-based Cadila Pharmaceuticals to conduct phase I clinical trial for its chicken pox vaccine.

The decision was taken in a recent meeting after the company submitted a revised phase I clinical trial protocol for grant of permission to conduct the trial for Varicella-Zoster Virus (VZV) vaccine.

“After detailed deliberation, the committee recommended for grant of permission to conduct phase-I clinical trial as per the presented protocol,” said the SEC-Vaccine in a meeting held on September 14, 2023.

The company had earlier submitted its proposal for grant of permission to conduct Phase I clinical trial of its Varicella-Zoster virus (VZV) vaccine along with preclinical data and it was considered in a SEC meeting held on May 16, 2023.

The SEC, during then, after detailed deliberation recommended that the company should submit single dose toxicity data as per the provisions of the New Drugs and Clinical Trials Rules, 2019.

Further, it recommended, the firm should revise the phase I clinical trial protocol with some changes such as the volume of blood to be withdrawn for analysis should be reduced.

According to the World Health Organisation (WHO) Varicella (chickenpox) is an acute, highly contagious disease caused by varicella-zoster virus (VZV), a member of the herpesvirus family.

“Only one serotype of VZV is known, and humans are the only reservoir. Following infection, the virus remains latent in neural ganglia and in about 10-20% of cases it is reactivated to cause herpes zoster, or shingles, generally in persons over 50 years of age or immunocompromised individuals,” it says.

It further stated that current varicella vaccines are attenuated vaccines based on the Oka VZV strain that has been modified through sequential propagation in different cell cultures. The attenuated strain is grown in cell culture, purified and lyophilized. Reconstituted vaccines are injected subcutaneously.

“Varicella vaccine has also been included in a combination vaccine with measles mumps rubella (MMRV). A vaccine which contains higher levels of the virus has also been developed for the prevention of shingles in the elderly,” added WHO.

It may be noted that Cadila Pharmaceuticals has launched world’s first novel three-dose rabies vaccine ThRabis, in April, 2022.

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