You can enroll for AIIMS's COVID-19 vaccine trials: Here's how
India's indigenous COVID-19 vaccine candidate, COVAXIN, is set to go into human trials at AIIMS Delhi. The shot, which has been cleared by the Drug Controller General of India (DCGI), will be given to hundreds of healthy volunteers who will be monitored to judge its efficacy and safety for widespread public use. Here's how you can enroll to be a part of the trial.
Trials to include people between 18 and 55 years
A few hours ago, the Ethics Committee of All India Institute of Medical Sciences (AIIMS), Delhi, approved COVAXIN's human trials. The study, the committee said, will begin with the enrollment of healthy volunteers starting Monday, July 20. To be eligible for it, you have to be aged over 18 years and less than 55 years and have no co-morbid conditions or history of COVID-19.
What kind of trial would this be?
According to Dr. Sanjay Rai, a professor at the AIIMS Center for Community Medicine, this trial will be a "randomized, double-blind, placebo-controlled" study. As part of this, some of the chosen participants will be given the experimental vaccine while some, a control group, will be given a placebo for comparison. Neither the administering staff nor the subjects would know what treatment they are giving/getting.
Are there any safety risks?
As these trials are aimed at defining the effectiveness and safety of the vaccine candidate in question, there is no way to be sure about safety aspects right now. The subjects could show mild-to-moderate, perhaps even severe, reaction to the shot days after being vaccinated. The intensity of the reaction could also vary with the dose being tested.
How to enroll for the trials?
That said, if you are eligible and willing to accept the risk and help with the trial of the COVAXIN candidate, send an email to ctaiims.covid19@gmail.com or text/call on 7428847499 to enroll for the trial. After that, you will be detailed about the study and called to the institute to complete the enrollment process.
A few participants already chosen: Rai
"We have already registered a few volunteers for the trial. From Monday onwards, our team will start their health screening before giving them vaccination," Dr. Rai told ANI.
375 participants to be enrolled for Phase 1 study
AIIMS Delhi is one of the 12 institutes chosen by the Indian Council for Medical Research (ICMR) for Phase 1 and Phase 2 trials of COVAXIN. In Phase 1, as many as 375 participants will be enrolled, of which 100 (maximum) could be from AIIMS. Other human trial sites are in Patna, Nagpur, Jajapur, Belgaum, Visakhapatnam, Hyderabad, Rohtak, Gorakhpur, Kanpur, Goa, and Kancheepuram.
When this vaccine will be available?
The experimental vaccine, developed by Hyderabad-based Bharat Biotech, has to clear Phase 1, 2, and the final and the largest Phase 3 of human trials to be ready for approval and public use. ICMR had previously said it aims to make the shot available by August 15, but Bharat Biotech's founder Dr. Krishna Ella believes it is too early to announce a launch date.
