Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475302
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu
All India Institute of Medical Sciences, New Delhi
National Institute for Research in Environmental Health, Bhopal, Madhya Pradesh
National Institute of Occupational Health, Ahmedabad, Gujarat
King Edward Memorial Hospital
National Institute for Implementation Research on Non-Communicable Disease
Information provided by (Responsible Party):
Tuberculosis Research Centre, India

Brief Summary:

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.

Secondary objectives:

  1. To evaluate the effectiveness of BCG vaccination in terms of

    1. reducing the cumulative incidence of hospital admission and Intensive Care admission
    2. reducing the incidence of other respiratory febrile illness
  2. 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.
  3. 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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2175 participants
Allocation: Non-Randomized
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)
Primary Purpose: Prevention
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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
  1. in the hotspots, those who do not agree for vaccination, will be considered as controls. They will have an entry and exit interview at baseline and end of study period
  2. in situations where we are unable to enrol the required number of controls from the vaccination hotspot zones, then hotspots in the neighbouring area / wards where BCG is not offered will be taken as control sites. Elderly between 60-80 years in those areas would be considered as control sites for the study. The elderly participants will be approached for an entry and exit interview, if they agree. If they do not agree for an exit interview at the end of 6-months, then the status of those in the control group would be collected either from the corporation records / other medical database.



Primary Outcome Measures :
  1. Mortality due to COVID-19 disease [ Time Frame: 6 months from study start date ]
    Number of deaths due to COVID-19 disease


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 60 years of age or older (<100 years) with general good health, as confirmed by history and physical examination.
  • No known history of HIV or on immunosuppressive drugs for malignancy or transplant
  • Provide a signed and dated informed consent form

Exclusion Criteria:

  • Positive for SARS-Cov2 infection
  • Known HIV or other immune-suppressive treatments for malignancy or transplant
  • Recently diagnosed as TB or currently on anti-TB treatment or anti-psychiatric medications
  • Has any BCG vaccine contraindication
  • H/o of previous administration of experimental MTB vaccines within the past 6 months.
  • Sick and moribund individuals with Karnofsky score <50

    • Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Subash Babu, MBBS, PhD 044-28369711 sbabu@nirt.res.in
Contact: Padmapriyadarsini Chandrasekaran, MBBS,DNB,MS

Locations
Layout table for location information
India
Tuberculosis Research Centre Recruiting
Chennai, Tamilnadu, India, 600031
Contact: Subash Babu, MBBS, PhD    91-44-28369711    sbabu@nirt.res.in   
Principal Investigator: Subash Babu, MBBS, PhD         
Sponsors and Collaborators
Tuberculosis Research Centre, India
ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu
All India Institute of Medical Sciences, New Delhi
National Institute for Research in Environmental Health, Bhopal, Madhya Pradesh
National Institute of Occupational Health, Ahmedabad, Gujarat
King Edward Memorial Hospital
National Institute for Implementation Research on Non-Communicable Disease
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Tuberculosis Research Centre, India
ClinicalTrials.gov Identifier: NCT04475302    
Other Study ID Numbers: 2020010
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs