Scientists analysing results of phase one safety trial of Covaxin
The results of the first phase of safety trials of India’s first domestic vaccine candidate are being analysed, officials said on Friday, and an expert panel will approve the next round once the results are in.
The Data Safety Monitoring Board (DSMB) of the vaccine will give nod to embark on the second phase of human trial, which will be to test the vaccine’s safety and immunogenicity, after analysis of results of 375 people, who were administered the vaccine in the first phase, said sources associated with the trial in New Delhi.
The DSMB is an independent panel of experts, constituted by the Bharat Biotech International Limited (BBIL). The DSMB has been approved by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO). The ICMR is partnering the BBIL in the trials of Covaxin (BBV152 Covid vaccine).
“We were advised to close ‘recruitment’ (enrolment of volunteers for the trial) yesterday after the 12 sites, selected for the trials, achieved the sample size of the first phase of trials. We will wait for DSMB nod before embarking on the second phase of trials,” said Dr CM Singh, professor of community and family medicine, also the principal investigator of the trial at AIIMS-Patna.
The institute is among 12 other sites the ICMR has approved for the human trial of the vaccine.
“We administered the vaccine on 46 people, of which nine have been given its second dose on the 14th day after the first shot of the vaccine. Only three volunteers complained of slight pain at the point of injection. There were no side-effects, which is an indication that the vaccine is safe,” said Dr Singh.
“Vaccine is to be given on 0 day and 14. The follow-up sampling to see the level of immunogenicity (ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human) has to be done on day 14, 28, 42, 104 and 194,” he added.
The second phase of the trial will be on 750 people that will be to check the vaccine’s safety and immunogenicity.
The ICMR has selected 12 institutes for the trial. They are AIIMS-Delhi, Nizam’s Institute of Medical Sciences, Hyderabad; PGMIS Rohtak; SRM Medical College Hospital and Research Centre, Chennai; AIIMS-Patna, Redkar Hospital, Goa; Gillurkar Multi-specialty Hospital and Research Centre, Nagpur; Sum Hospital, Bhubaneswar; Jeevan Rekha Hospital, Belagavi (Karnataka); King George Hospital, Visakhapatnam; Prakhar Hospital, Kanpur; and Rana Hospital, Gorakhpur.
The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.