Chandigarh: A first-of-its kind study on Covid vaccines to understand the immunologic response, tolerability, and side effects of Covishield and Covaxin when taken in combination would be conducted jointly by the Punjab government's Chandigarh health department, and the Post Graduate Institute of Medical Education and Research (PGIMER).
The institute released a notice on 14th November, 2022 calling volunteers for the Covishield/Covaxin study by ICMR/PGIMER under the project entitled 'Safety, tolerability and immunogenicity after administration of Covid-19 vaccine in homologous prime/boost schedule Covishield Covishield or Covaxin Covaxin as compared with heterologous prime/boost Covishield Covaxin or Covaxin Covishield schedule among adults in North India.'
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The study protocol, sanctioned by the Indian Council of Medical Research (ICMR), the apex body of biomedical research in India aims to look at the immunologic response, tolerability, and side effects of Covishield and Covaxin when both are taken in combination as first and second dose. The study protocol was approved by the Centre (DCGI) and Ethics committee of PGl.
The study requires 1,028 healthy unvaccinated volunteers, who would then be given Covishield as the first dose and Covaxin as the second dose and vice versa. The combination result would be compared with findings in volunteers getting the same vaccine as the first and second doses. PGI and BR Ambedkar Institute of Medical Sciences, Mohali are chosen as the inoculation sites.
The principal investigator of the project is Prof Madhu Gupta, Department of Community Medicine and School of Public Health, PGI, Principal Investigator for the clinical trials of the Oxford Covid-19 vaccine at the institute.
The study would help in addressing issues of vaccine shortage and wastage in the country and in improving the immune boosting response. Corbevax has already been approved by the Centre as a booster dose for Covishield and Covaxin after a previous such study.
Speaking to Indian Express, Prof. Gupta said, "Many studies abroad show that mixing vaccines leads to a better antibody production. I wrote this project a year back and it has been approved by the ICMR and the Drug Controller General of India. We have received funding from the ICMR and many departments of PGI, including internal medicine, will be part of this project, apart from the Punjab government, and the health department of Chandigarh. If you establish evidence, you can get many advantages, as there are many people who haven't yet taken both doses of the Covid vaccine. And we have not stopped the vaccination drives in the country. I urge people who have not been vaccinated to come forward and contribute new evidence. We want to follow the volunteers for a year and study the antibody response and cell-mediated immunity. Both vaccines are safe, and this will be an opportunity for us to take our research further. We will be recruiting volunteers in December end or January beginning."
The Chandigarh administration urged volunteers who meet the criteria to participate in the study and suggested them to contact via the given phone number and email-id in the notice.
The team had previously reported about the findings of an ICMR study which had observed that combination of two different vaccines Covishield and Covaxin jab lift up immunity better than same dose plan, which was published in the Journal of Travel Medicine. The researchers had carried out the study with an aim of assessing the safety and immunogenicity of the heterologous prime-boost COVID-19 vaccination.
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