AIIMS Coronavirus Vaccine Trial: 1 out of 5 people who had signed up for Covaxin trial already have antibodies
A portion of people who had applied to enroll for AIIMS coronavirus vaccine trial for India’s first indigenous vaccine, Covaxin have already developed antibodies against the novel coronavirus. The sources at AIIMS said that about 20% of the enrolled people in trial have thus been rendered unfit for the trial.
It has been two weeks that AIIMS had started enrolling participating people for the Covaxin trial, only 16 have been recruited from the 80 screened volunteers. India’s pioneer medical institute is set to administer first dose of Covaxin vaccine to 100 people, who will then be examined and monitored for two weeks.
Compliment IMS & Sum Hospital, the only such institute in Odisha to be chosen by ICMR for the purpose. Indigenously developed Covaxin is another testimony of India's colossal capabilities in healthcare innovation. My prayers and best wishes for its success.— Dharmendra Pradhan (@dpradhanbjp) July 28, 2020
The eligibility criteria for participating people in trial include age range of 18 years to 55 years, and they must be free from any heart, kidney, liver or lung pre-existing ailment. Furthermore, they must not have uncontrolled diabetes and hypertension. Before recruitment of the volunteers, they have to undergo routine investigations like liver function tests, kidney function tests, Covid-19 detections and rapid antibody test to determine if there are any prior antibodies against the virus.
A senior doctor at AIIMS who is associated with the trial said, “The rejection rate is very high as we can only recruit healthy volunteers. In almost 20% of the volunteers, we have found antibodies. This means they have already been infected. The remaining people do not have optimum liver or kidney function.”
If a person is already showing antibodies it is indicative of that he has already been infected by the coronavirus. This makes that person strictly unfit to participate in the trial.
So far, AIIMS has received close to 3,500 applications to participate in the human trials of Covaxin vaccine. As part of trial, on July 24 a 30 year old male was administered with the first dose of Covaxin, which was 0.5 ml given intra-muscular. The doctor in charge said that it has been one week since the dose and the person doesn’t complain of any discomfort. After Friday he will be given the second dose of vaccine.
AIIMS is among the 12 sites selected by ICMR for different phases trials of coronavirus vaccine. The phases include Phase I and II randomized, double-blind (neither the patient nor the doctor knows which patient is receiving placebo and which is receiving vaccine), and placebo-controlled clinical trials for Covaxin. Phase I would constitute dose administration in 375 patients. AIIMS is to have the maximum of these, 100. Phase II will have total of 750 volunteers in all the 12 sites put together.
Covaxin vaccine is India’s first indigenous vaccine which has been developed by Hyderabad-based pharmaceutical company Bharat Biotech in association with the National Institute of Virology and ICMR (Indian Council of Medical Research). Clinical Trials of Phase I and Phase II have been approved by Drug Controller General of India.