BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots
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|ClinicalTrials.gov Identifier: NCT04475302|
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : July 8, 2022
Rationale: SARS-CoV2 viral infection is spreading rapidly throughout the world and in India the epidemic poses a major threat to the public health system. Elderly individuals, especially those with diabetes, hypertension, other chronic diseases are at high risk of mortality. Strategies to protect these individuals are desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (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.
Primary Objective: To evaluate the effectiveness of BCG vaccination in preventing morbidity and mortality due to COVID-19 in elderly individuals aged between 60 to 80 years living in COVID-19 hotspots in India.
To evaluate the effectiveness of BCG vaccination in terms of
- reducing the cumulative incidence of hospital admission and Intensive Care admission
- reducing 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.
- To measure biomarkers induced by BCG vaccination as correlates of risk/protection against SARS-Cov2 in a subset of individuals
Method and Analysis:
Study design: Intervention study Study population: Elderly 60 - 80 years of age residing in designated hotspots for SARS-Cov2 infection Study Intervention: 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. Study sites: Chennai, Mumbai, Ahmedabad, Bhopal, Jodhpur and New Delhi. Study Sample size: 1450 individuals between 60-80 years of age will receive BCG vaccination while 725 individuals will be controls without vaccination Study duration: 6 months/participant. Enrolment at each site will be over: 4 months. Each participant will be followed for 6 months post vaccination. Primary Outcome Measures: During the study period (6-months), Proportion of individuals receiving the BCG vaccination who are asymptomatic but become PCR-positive or seroconvert during the 6-month of study period. Proportion of patients with development of COVID-19 disease (either PCR-positive or seroconvert with symptoms) during the study period. Proportion of patients with Severe COVID-19 disease and death due to Covid-19 disease
|Condition or disease||Intervention/treatment||Phase|
|COVID||Biological: BCG vaccine (Freeze-dried)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2175 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||In this study, as we are employing a control group that is not vaccinated against the disease to be prevented, but some clinical data are available to support the likely efficacy of the candidate vaccine, we will use unbalanced randomization and enrol participants to control group in the ratio of 2:1, so that majority of the study participant will receive the vaccine|
|Masking:||None (Open Label)|
|Official Title:||Study to Evaluate the Effectiveness of BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots in India|
|Actual Study Start Date :||July 1, 2020|
|Actual Primary Completion Date :||September 20, 2021|
|Actual Study Completion Date :||September 20, 2021|
Experimental: Intervention arm
In the identified hotspots, BCG vaccine will be offered to all the elderly between 60 - 80 years of age. Those who get vaccinated will be followed for a period of 6-months.
Biological: BCG vaccine (Freeze-dried)
single dose of BCG vaccine (Freeze-dried) manufactured by Serum Institute of India, Pune. The composition of BCG vaccine is Live, attenuated BCG (Bacillus Calmette-Guerin Strain). (Each 1 ml contains between 2 x 106 and 8 x 106 Colony Forming Units (C.F.U.) with Diluent: Sodium Chloride Injection I.P.)
No Intervention: Control arm
- Mortality due to COVID-19 disease [ Time Frame: 6 months from study start date ]Number of deaths due to COVID-19 disease
- Hospital admission and ICU admission due to Covid-19, Severity of Covid-19 (mild, moderate or severe), Hospital admission due to other respiratory febrile illness, immunological outcomes in the sub study [ Time Frame: 10 months from study start date ]Number of hospital admissions and ICU admissions due to Covid-19 and other respiratory disease, Number of COVID-19 cases reported based on severity level (mild, moderate or severe) and immunological outcomes in the sub study (baseline and at 1, 3 and 6 months post vaccination).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475302
|Tuberculosis Research Centre|
|Chennai, Tamilnadu, India, 600031|
|Principal Investigator:||Padmapriyadarsini Chandrasekaran, MBBS,DNB,MS||National Institute for Research in Tuberculosis|
|Principal Investigator:||Anant Mohan||All India Institute of Medical Sciences, New Delhi|
|Principal Investigator:||Randeep Guleria||All India Institute of Medical Sciences, New Delhi|
|Principal Investigator:||Tiwari R R.||National Institute for Research in Environmental Health|
|Principal Investigator:||Yogesh Sabde||National Institute for Research in Environmental Health|
|Principal Investigator:||Kamalesh Sarkar||National Institute of Occupational Health|
|Principal Investigator:||Asha Keetharam||National Institute of Occupational Health|
|Principal Investigator:||Hemant Deshmukh||KEM Hospital|
|Principal Investigator:||Rujuta Hadaye||GSMC and KEM Hospital|
|Principal Investigator:||Toteja G.S.||National Institute for Implementation Research on Non-Communicable Disease|
|Principal Investigator:||Subash Babu, MBBS, PhD||NIH-International Center for Excellence in Research|