Serum Institute Conducts Phase 3 Clinical Trial Of BCG Vaccine

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The Serum Institute of India is conducting phase III clinical trial of BCG vaccine candidate VPM1002 to evaluate its ability in reducing infection and severe disease outcomes of COVID-19 among high-risk persons of advanced age, comorbidities and high-exposure healthcare workers (HCWs), the Department of Biotechnology said in a statement.

About 6,000 health workers and high-risk individuals including those in close contact of COVID-19 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, the statement added.

The BCG vaccine is administered routinely to all newborns as 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 induction of trained innate immunity and heterologous adaptive immunity.

"Serum Institute of India Pvt Ltd (SIIPL) has been supported under Department of Biotechnology's National Biopharma Mission for conduct of a multi-site 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)," the statement said.

Renu Swarup, Secretary, DBT and Chairperson, BIRAC said the 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 6,000 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," she said.

The DBT statement quoting Adar Poonawalla, the owner and CEO of Serum Institute of India (SII) said, "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."

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