Human clinical trials of Covaxin will also begin tomorrow, 22 July, at a Bhubaneswar-based institute. It is one of the 12 centres selected by the ICMR for conducting phase one and two of the clinical trials.
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On July 17, human trials of Covaxin began at Post-Graduate Insitute if Medical Sciences (PGI) in Rohtak and some other places.
How vaccine trial will be unfolded in India?
AIIMS-New Delhi is one of the 12 sites chosen by the Indian Council of Medical Research for conducting human trials of the Covid-19 vaccine candidate. While the ethics committee of the AIIMS-New Delhi has already given the human trial a go-ahead, a similar approval is awaited at the other 11 medical facilities.
So far, around 1800 people have registered as volunteers at AIIMS-New Delhi alone.
Speaking to media about the human trial, AIIMS Director Dr. Randeep Guleria said that the trial will be conducted in three phases.
- Covaxin's phase I trials will see participation from 350 people across the country. Of these, the maximum 100 volunteers will be taking part in the trial being held at AIIMS-Delhi. The first 50 will get the first dose of the vaccine. If the vaccine is marked as safe then it will be administered to the other 50 patients.
- Overall, 375 volunteers between the age group of 18-55 years will participate in Phase 1. Only people with no co-morbidities and women with no pregnancy will be selected to be part of the trial in the first phase.
- "If the first phase we see if the vaccine is safe and how much of the dose can be administered. Multiple doses will be tried. First, low doses will be administered, and if it's safe then we will increase the dose and see if it's effective. The results of the first phase are expected in the next two-three months", Dr. Randeep Guleria said
- The phase II trials for Covaxin, on the other hand, will have 750 people participating across the country. These people will be between the age of 12-65 years, Dr. Guleria said.
- In Phase II, the researchers will test Covaxin's ability to induce an immune response against the novel coronavirus.
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- In both phases, participants will be divided into four groups. Three of these will receive either one of three Covaxin formulations. The last group, a 'control' group, will receive a Japanese encephalitis vaccine that was previously developed and successfully tested by Bharat Biotech.
- The control group also known as the placebo group, is meant to help researchers compare and better understand the effects of Covaxin once it is in the human body. Some people will get the vaccine and some will not, to see the difference of immunogenicity in two groups. No participant will know whether he/she is receiving the experimental vaccine or the 'comparator' agent.
- And in Phase III, the effects of medicine in a larger population will be checked to see its efficacy and therapeutic benefit.
When can we expect the vaccine to be ready?
The head of Centre for Community Medicine Department in AIIMS, Dr. Sanjay K Rai said that there are chances that by end of this year or early next year, we will have a vaccine.
"Launching of the vaccine depends on its overall trial. We will have to check the effectiveness of the vaccine for at least six months. By the end of this year or early next year, there are chances that we will have a vaccine," Dr Rai told ANI.