1 in 5 who enrolled for Covaxin trials already had antibodies
The All India Institute of Medical Sciences, Delhi is currently conducting Phase I trials of India’s first homegrown coronavirus vaccine candidate Covaxin, to battle against the novel coronavirus. After getting regulatory approval from the Drug Comptroller of India (DCGI), 12 institutes were selected across the country, including AIIMS Delhi and Patna to start the human trials of Covaxin.
Only 16 volunteers have been selected for clinical trials
AIIMS Delhi has already screened in 80 volunteers ever since it started enrolling the volunteers for clinical trials of India’s first indigenous COVID-19 vaccine. However, as of now, only 16 volunteers have been selected to undergo clinical trials as the rejection rate is very high. According to a report published in the Indian Express, almost 20 per cent of the volunteers who had signed up for the Covaxin trial had already developed protective antibodies against the novel coronavirus. This simply meant that they had already contracted COVID-19 in the past and recovered from the same.
Who are eligible to participate in the Covaxin trials?
To participate in Phase I of human trials, the volunteer needs to be a healthy individual between the age of 18 to 55, without any co-morbidities. In the first phase of Covaxin human trials, 375 volunteers will be recruited, out of which AIIMS will enrol 100 volunteers to participate in the randomised, double-blind, placebo-controlled clinical trials.
Before a volunteer is recruited, a series of medical tests are conducted to check all the major health parameters (hypertension, diabetes, chronic kidney illness, poor liver function etc) and rapid antibody test is also performed to check for protective antibodies against novel coronavirus.
20 % of volunteers already had antibodies against COVID
As per the report, the rejection rate is very high while recruiting the volunteers for Covaxin Phase I trials as roughly 20 per cent of those who had signed for the human trials had already developed antibodies against COVID-19. This made them unfit for the trials. This is because the presence of antibodies can make it difficult to study the correct impact of the Covaxin.
India’s first ingenious vaccine has been developed using an inactivated version of the spike protein of the novel coronavirus and aims to trigger an immune system response in the body with the production of protective antibodies. The potential vaccine has been produced by the Hyderabad-based Bharat Biotech in collaboration with the National Institute of Virology and Indian Council of Medical Research (ICMR).