The randomised controlled study will enroll at least 1,600 participants to determine the safety and immunogenicity of Covishield. (Representational image)
The KEM Hospital and Research Centre at Vadu, 20 km from Pune, is planning to conduct a sentinel sero-surveillance to monitor the trend of SARS-nCoV-2 infection transmission in the general population in rural western India.
“The purpose of our study is to generate information about the extent of Covid-19 spread in the community, which is currently lacking in India. The development of antibodies is a sign of exposure to Covid-19 infection and is believed to render immunity,” Dr Sanjay Juvekar, principal investigator of the study, told The Indian Express.
The study is being funded by the RESPIRE unit of the University of Edinburgh along with Translational Health Science and Technology Institute (THSTI). The RESPIRE unit is a global health research unit focusing on respiratory health in Asia.
Dr Ashish Bawdekar, co-investigator of the study, said they were looking at a sample size of 11,000 people. The study will be carried out in three age groups: 1 to 17 years, 18 to 50 years and older than 51 years. This study is likely to help us understand the extent of transmission in different age groups and both genders of the population and the rate at which new cases are occurring over time, the authors said.
Dr Sanjay Mehendale, former additional director general of Indian Council of Medical Research, and presently director, research at P D Hinduja Hospital and Medical Research Centre, was instrumental in conceptualising the study.
Researchers plan to take 2 to 3 ml of blood samples to test them for presence of antibodies against Covid-19. The interview and blood collection procedure will take 20 minutes and the survey will commence next week. At least five rounds will be conducted and in each round, 2,700 individuals will be enrolled. THSTI will test the samples.
According to study researchers, the survey and laboratory tests will inform people about the precautionary measures to be taken to save their family members, colleagues and friends from getting infected.
SII hopes to get nod for Covid vaccine trials within week
Adar Poonawalla, CEO of Serum Institute of India (SII), said they had submitted details of the proposed clinical trials for a Covid-19 vaccine to the DCGI a few days ago. While he refused to comment on the Central Drugs Standard Control Organisation (CDSCO) asking SII to submit a revised protocol to perform clinical trials for a potential Covid-19 vaccine in India, Poonawalla said they were sure to get the approvals within a week.
The CDSCO’s subject expert committee had sought additional information about the protocol for phase 2 and 3 clinical trials. The SII has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19, ‘Covishield’.
The randomised controlled study will enrol at least 1,600 participants to determine the safety and immunogenicity of Covishield. While SII officials said that over 10 clinical sites will be part of the trial, four sites were identified in Pune. Last week, Oxford University had announced satisfactory progress with the vaccine after which SII had proposed clinical trials in India.