Covaxin trials in AIIMS: Around 20% of vaccine trial’s prospective volunteers already had antibodies; Details

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August 4, 2020 9:57 AM

AIIMS would be administering the vaccine candidate to 100 participants in the trial, and the institute would be monitoring the volunteers for a period of at least two weeks after they get the first shot.

Covaxin has been developed by Bharat Biotech, a pharmaceutical company based in Hyderabad.Covaxin has been developed by Bharat Biotech, a pharmaceutical company based in Hyderabad.

Coronavirus AIIMS vaccine trial: The All India Institute of Medical Science (AIIMS) has been aiming to conduct clinical trials for Covaxin, India’s first indigenous vaccine against the novel coronavirus. However, according to a report in IE, as many as 20% of the people who have expressed an interest in participating in the trials have been found unfit for the study on the grounds that they had already developed antibodies against the virus. The report said that the institute has screened over 80 volunteers in the two weeks since it began enrolling the participants.

Only 16 people have been selected for the study so far, the report added. AIIMS would be administering the vaccine candidate to 100 participants in the trial, and the institute would be monitoring the volunteers for a period of at least two weeks after they get the first shot.

The study is open to all volunteers aged between 18 and 55 years, who do not have uncontrolled diabetes, hypertension, or any liver, lung, heart or kidney illness. The volunteers are being tested for their kidney and liver functions, and for the detection of COVID-19 and they also undergo the rapid antigen test, before they are selected for the study, the IE report added.

The report quoted a senior doctor, who is closely monitoring the trials, as saying that the rejection rate among volunteers is very high, since only healthy ones can be recruited. Antibodies have been found in around 20% of the volunteers indicating that they had already been infected by the coronavirus, the doctor added. Apart from that, others were found ineligible on the grounds of subpar liver or kidney functions.

Antibodies are developed in a person who has already been infected by the virus and has recovered from it. Therefore, the impact of the vaccine on such patients would be hard to study, the doctor added.

The report added that the institute has received more than 3,500 applications from volunteers hoping to take part in the study. A 0.5 ml dose of Covaxin was administered to a 30-year-old male on July 24 through intramuscular injection. The doctor was quoted as saying that the volunteer had completed the first week after the administration of dose and has not yet reported any discomfort. The volunteer is scheduled to be monitored till Friday before he is administered the second dose.

AIIMS is one of the 12 centres that have been chosen by the Indian Council of Medical Research (ICMR) for conducting Phase I and II randomised, double-blind, placebo-controlled clinical trials. Double-blind trials indicate that neither the patient nor the person delivering the vaccine know who is getting it. The vaccine would be tested on a total of 375 volunteers in the first phase, with the highest number volunteers being in AIIMS, Delhi. The second phase would have a total of 750 volunteers from all the 12 sites.

Covaxin has been developed by Bharat Biotech, a pharmaceutical company based in Hyderabad. The development of the vaccine was done in collaboration with the ICMR and its Pune-based National Institute of Virology, the report added. The phase I and II human clinical trials were approved by the Drug Controller General of India earlier.

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