Dr. Reddy’s Laboratories has announced that the Phase II clinical trial of the Russia’s Covid-19 vaccine Sputnik V met the primary endpoints of safety.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik V is based on human adenoviral vector platform.
The randomised, double-blind, parallel-group, placebo-controlled study in India enrolled 100 participants.
An independent Data and Safety Monitoring Board (DSMB) reviewed the safety data from the trial and found no safety concerns.
DSMB also advised continuing the clinical trial without any amendments and recommended Phase III participants recruitment.
The company has submitted the safety data of the vaccine to the Drugs Controller General of India (DCGI) for review and approval to progress into Phase III clinical trials.
Dr. Reddy’s Laboratories co-chairman and managing director G V Prasad said: “The Indian clinical trial being conducted by Dr. Reddy’s and RDIF is an adaptive design Phase II/III trial.
“It is a bridging study to the larger global Phase III study on 31,000 subjects. The Phase II study in India showed a very good safety profile.”
Clinical trials of Sputnik V are currently progressing in the UAE, Egypt, Venezuela and Belarus while Algeria, Argentina, Belarus, Bolivia and Serbia have already registered the vaccine.
Furthermore, over one million people in Russia and more than 300,000 individuals in Argentina have been inoculated with Sputnik V so far.
Russian Direct Investment Fund CEO Kirill Dmitriev said: “The safety data from the Phase II clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets.
“The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”
Last month, Dr Reddy’s and RDIF initiated adaptive Phase II/III clinical trials for Sputnik V vaccine in India.