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AIIMS-Patna to begin trial of another Covid vaccine from Nov 16
The first dose of the vaccine will be administered after running some routine tests on a volunteer. The second dose will be administered 28 days later.
The first phase of the human clinical trials of another vaccine against Covid-19 of Biological E, a biopharmaceutical company based in Hyderabad, will begin at the All India Institute of Medical Sciences (AIIMS), Patna, from November 16, the principal investigator of the trial at the facility said Friday.
Healthy individuals between 18 and 55 years of age can enroll for the trial voluntarily by calling up the registration section of the community and family medicine department (9471408832), said Dr CM Singh, professor and head of community and family medicine and also the principal investigator of the trial at AIIMS-Patna.
The first dose of the vaccine will be administered after running some routine tests on a volunteer. The second dose will be administered 28 days later, he added.
“The follow-up sampling to check the level of immunogenicity (amount of antibody titer produced in a healthy body to fight against the SARS CoV-2 virus, which causes Covid-19) has to be done on day 14, 28, 42, 104 and 194,” said Dr Singh.
The institute will reimburse the cost on travel incurred by a volunteer during the trial period.
It is the fifth vaccine candidate to move into human trials. Serum Institute of India’s Covishield, co-developed by AstraZeneca plc and University of Oxford is the furthest in phase 3, while Bharat Biotech International Ltd will take its Covaxin into the last stage next month. Zydus Cadila is currently in phase 2, while Dr Reddy’s Laboratories Ltd will soon initiate its phase 2 and 3 trials, for which it received approval last month.
The Subject Expert Committee that advises the Drug Controller General of India on applications seeking permission for new drugs, clinical trials, vaccine for Covid-19, gave its approval to initiate phase 1 and 2 human trials for the Biological E vaccine in India on October 26.
At least three other institutes, including AIIMS-Delhi and Safdarjung hospital, have been shortlisted for this trial. The AIIMS-Patna has been given a sample size of 12-18 individuals in the first phase of trial.
The AIIMS-Patna has completed two phases of human trials of an earlier Covaxin (BBV152 Covid vaccine), the country’s first indigenously developed Covid-19 vaccine of the Bharat Biotech International Limited (BBIL), Hyderabad. It is awaiting approval to initiate phase 3 trial, likely to begin in December, said officials.
The Data Safety Monitoring Board (DSMB), an independent panel of experts constituted by the Bharat Biotech International Limited (BBIL), had tried the vaccine on 375 people across the country in the first phase. It had set a sample size of 750 healthy volunteers for the second phase trial, said officials.
AIIMS-Patna had administered the vaccine to 44 volunteers in the first phase and 46 in the second, all of whom were responding well, said officials.
The first phase trial is to check the safety of the vaccine. The second phase tests its safety as well as the level of immunogenicity.
