The India Council of Medical Research (ICMR) is all set to conduct a study to evaluate the effectiveness of the BCG vaccination in preventing morbidity and mortality due to COVID-19 in elderly individuals between 60 to 95 years of age living in COVID-19 hotspots in India.
This study will be carried out in six states (sites) of the country--Tamil Nadu, Maharashtra, Gujarat, Madhya Pradesh, Rajasthan, and Delhi.
The ICMR's National Institute for Research in Tuberculosis (NIRT) in Chennai is heading the study. In Tamilnadu, this study will be done in close collaboration with the Greater Chennai Corporation and Department of Public Health of the State.
"The study will document whether the BCG vaccine can prevent the occurrence of the SARS-CoV-2 infection and its progression and death associated with COVID-19 among elderly individuals.
The study uses the same BCG vaccine that is administered to newborn babies as a part of the National Immunization program for more than 50 years in this country," Dr. Subash Babu, Scientific Director at National Institute of Research in Tuberculosis told ANI.
According to the ICMR scientist, BCG is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in-vitro and in-vivo studies, and reported significant reductions in morbidity and mortality.
"Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children and adults, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination will partially protect against mortality in high-risk, elderly individuals," said the scientist.
He informed that there are several clinical trials using the BCG vaccine already undergoing an elderly population across the globe.
"We have to evaluate the effectiveness of BCG vaccination in terms of reduction in the cumulative incidence of hospital admission and Intensive Care Admission, reduction in the incidence of other respiratory febrile illness, to determine the innate and adaptive immune responses, IgM, IgG and IgA antibody titers generated by BCG vaccination (both total and SARS-Cov2 specific) in a subset of individuals and to measure biomarkers induced by BCG vaccination as correlates of risk or protection against SARS-Cov2 in a subset of individuals," added Dr. Babu.
The methodology of the study sample size is 1450 healthy individuals between 60 -95 years of age who will receive BCG vaccination while 725 individuals will be controls (without vaccination), who will be followed up for six months post-vaccination.
The participants are elderly population from 60 - 80 years of age residing in red and orange zones (hotspots) for SARS-Cov2 infection.
The participants will be administered one dose of 0.1ml BCG vaccine, given intradermally. Elderly individuals not vaccinated from the same hotspot area or from neighbouring hotspot wards areas will be considered as the controls.
Apart from Chennai`s NIRT site, the five other centers are National Institute of Occupational Health, Ahmedabad in Gujarat, National Institute for Research in Environmental Health in Bhopal in Madhya Pradesh, GS Medical College and KEM Hospital in Mumbai Maharashtra, National Institute for Implementation Research on Non-Communicable Diseases in Jodhpur and AIIMS, New Delhi.