Updated: August 26, 2020 10:20:48 am
The Phase 2 human trials of Oxford University’s Covid-19 vaccine, manufactured at the Pune-based Serum Institute of India, began on Tuesday, with the first dose of vaccine set to be administered to six trial participants at the Bharati Vidyapeeth Medical College and Hospital in Pune on Wednesday.
On Tuesday, as part of the process, the three men and women each were screened. They will be administered the vaccine if their RT-PCR and antibody test reports are clear.
“We are enrolling six persons for the trial, and the screening process is underway. Their RT-PCR and antibody tests are being conducted. If the reports are favourable, the vaccine doses will be administered,” Dr Sanjay Lalwani, medical director of Bharati Vidyapeeth’s medical college and hospital, confirmed to The Indian Express.
The vaccine candidate, developed by Jenner institute of Oxford University, will be launched under the brand name “Covishield” in India. The Serum Institute has tied up with British-Swedish pharmaceutical firm AstraZeneca to produce 1 billion doses of the vaccine in the country.
The vaccine is made from a weakened version of a common cold, adenovirus, taken from chimpanzees and genetically modified. The vaccine candidate – ChadOx1NcOV – has shown encouraging results in early human trials, according to experts. Results of the phase 1/2 trial, published in ‘The Lancet’ medical journal, shows that the vaccine had induced strong immune response.
On August 3, the Drug Controller General of India (DCGI) had given the go-ahead to Serum Institute for conducting phase-2 and -3 human clinical trials of the vaccine candidate in the country.
According to the Clinical Trials Registry-India, Covishield will be administered as a two-dose schedule — 0.5 ml dose intramuscularly on Day 1 and Day 29. Placebo will be administered as a two-dose schedule on Day 1 and 29 – 0.5 ml dose intramuscularly.
The observer-blind, randomised controlled study will determine the safety and immunogenicity of Covishield vaccine on healthy Indian adults.
Among the trial sites include four in Pune (Bharati hospital, KEM Hospital and Research Centre, Jehangir Hospital and BJ Medical College), AIIMS in Delhi, Rajendra Memorial Research Institute of Medical Sciences in Patna, Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, among others.
It is learnt that two other sites have been identified for Phase 2 of human clinical trial of Covishield, which will receive vaccine doses in the next few days: KEM-Pune and PGI-Chandigarh.
Experts at various clinical trial sites said that there is a rush of queries through emails and telephone, with several willing to participate as volunteers in the vaccine’s human trial. “The response has been huge – people are calling us, wanting to enrol in the clinical trial,” Dr Lalwani said.
What happens during Phase-2 human trial
A total of 1,600 people will be enrolled for trials in phases 2 and 3.
In phase 2, approximately 100 participants will be enrolled and vaccinated across various sites. This is mainly to assess the vaccine’s safety; its side-effects, if any, will be recorded.
The vaccine doses have to be administered within seven days of enrolment, and this safety cohort will be followed for a week. There will be a temporary halt, when the data safety monitoring board will assess the results. After 10 days, the phase 3 part of the study will begin, which will include 1,500 trial participants.
Volunteers above 18 years have to provide an informed consent to participate in the trial.
Initial screening visits will include nasopharyngeal swab tests and blood samples will be taken to rule out coronavirus infection in the participants. Social distancing will be practised.
Once the vaccine is administered the trial participant will be monitored for the next half hour and then sent home. There will be a follow-up for the next six months.
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