SII enrols 6000 subjects for efficacy trial of rBCG vaccine, VPM1002 against COVID-19

Serum Institute of India (SII) has been supported under Department of Biotechnology’s National Biopharma Mission for the conduct of a multisite randomised double-blinded placebo-controlled phase III clinical trial of a recombinant BCG vaccine candidate, VPM1002. The objective of this trial is to evaluate the ability of VPM1002 in reducing infection incidence and severe disease outcomes of COVID-19 among high-risk persons of advanced age or co-morbidities and high-exposure healthcare workers (HCWs).

BCG vaccine is administered routinely to all new-born babies as a part of the national childhood immunisation programme to prevent tuberculosis (TB), an infection caused by bacteria that mainly affects the lungs. It has beneficial heterologous effects and proven antiviral and immune-modulatory properties that protect against infectious diseases through the induction of trained innate immunity and heterologous adaptive immunity. About 6,000 health workers and high-risk individuals, including those in close contact of COVID patients, have been enrolled in a clinical trial to determine if the recombinant Bacillus Calmette-Guerian (rBCG) can boost immunity to fight against the virus.

Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said, “BCG vaccine is a proven platform and utilising its off-target effects for diseases other than TB is a very pragmatic approach to take. The trial began in May 2020 and has completed enrolment of 6000 subjects in almost 40 hospitals across the country. This is an important milestone, in the quest for preventing the disease and we look forward to the results of this important trial”.

“We are delighted to partner with DBT-BIRAC for this study and look forward to the positive results of the trial, which should be available before the end of this year”, said Adar Poonawalla, owner and CEO, Serum Institute of India (SII).

There is an urgent need to ensure the safety and health of HCWs who are on the forefront fighting the epidemic, household contacts of COVID positive patients and all other people residing or working in COVID-19 hotspots/outbreak areas where there is a high risk of transmission of COVID-19 infection. Paul Ehrlich Institute (PEI) and Health Canada also approved similar trials with rBCG.