The Post Graduate Institute of Medical Education and Research (PGIMER) has been identified and approved by the ICMR as a site for conducting the concurrent Phase 2 and Phase 3 clinical trial of the Oxford Covid-19 vaccine candidate. The Serum Institute of India, which has a tie up with Oxford to potentially manufacture the vaccine in India, received an approval from the Drug Controller General of India on Monday to conduct late stage human trials of the vaccine in India.
The Oxford Covid-19 vaccine, which was developed in association with the Swedish-British firm AstraZeneca, has already successfully undergone preliminary phase 1/2 human safety 1 and immunogenicity trials, the results of which were published in the Lancet as well. Apart from safety and immunogenicity, the concurrent phase 2 and 3 trial to be conducted in India now will also look for the efficacy of the vaccine in preventing an individual from catching the disease. Marketed by the Pune based Serum institute as COVISHEILD, the vaccine will undergo trials across 17 approved sites in India including PGIMER.
Though the trial has been approved by the ICMR, it is yet to be approved by the ethics committee of PGIMER. “We have been approved by ICMR and the Serum Institute. We have all the facilities available to conduct the trial. Out internal ethics committee will flesh out and approve the final proposal for the trial now,” says Dr Madhu Gupta from the Department of Community Medicine, who will be the Principal Investigator for the trial at PGIMER. According to Gupta, the trial should begin by the end of August and last till the end of this year at least. “All the centers are aiming to have their set of volunteers by August 25,” added Gupta.
Responding to the announcement, PGIMER Director, Professor Jagat Ram, said, “It’s an honour to be entrusted with this vital responsibility of being one of the sites for phase 2, 3 trials on the Covishield vaccine. The results of phase 1 trials in the UK have been optimistic and did not present any serious adverse side effects. Phase 2 and 3 trials will be done on a larger human population to see its efficacy and requisite protection against Covid-19 in humans.”
The trial will have up to 1,600 participants across all the centers in India. According to Dr Gupta, the trial at PGIMER will mainly look at the safety of the vaccine, and not the efficacy. “The trial is initially focused at seeing how safe the vaccine is in a larger pool of people, and checking these volunteers for their antibody production. But even the antibody monitoring is more likely to happen at NIV Pune and so the volunteers have to be from around that area,” says Gupta.
Though the institute is yet to reveal the detailed inclusion/exclusion criteria for volunteers of the trial, Dr Gupta says that all volunteers have to be healthy adults without serious underlying conditions. “If you are undergoing treatment for some other disease currently or have Covid-19, you won’t be eligible. This is because a side effect of the vaccine could result from its interaction with another health condition in your body, but again who will be approved and considered ‘healthy’ enough for the trial will be fleshed out as we recruit volunteers. All these volunteers will be screened thoroughly before they are accepted for the trial,” adds Dr Gupta.
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