None listed
Conditions
Interventions
Intervention1: BCG vaccine: Single dose of
0.1ml of BCG vaccine given intradermally
(BCG-Serum Institute of India) over the distal insertion of the deltoid muscle onto the left humerus (approximatel
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1)Elderly individuals 60 years â?? 95 years of age with general good health, as confirmed by history and physical examination. 2) No known history of HIV or on immunosuppressive drugs for malignancy or transplant 3) Provide a signed and dated informed consent form 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.
Exclusion criteria
Exclusion criteria: 1) Positive for SARS-Cov2 infection, by either antibody (serology) or PCR test 2) Known HIV or malignancy or Transplant recipient or on Dialysis 3) Individuals on immune-suppressive therapies or treatments for malignancy or transplant / dialysis / anti-retroviral treatment 4) Recently (in the last 6-months) diagnosed with TB or currently on anti-TB treatment or anti-psychiatric medications 5) Has any BCG vaccine contraindication like allergy or hypersensitivity to BCG, individuals with HIV infection, leukaemia, malignant lymphoma, chronic granulomatous disease, 6) H/o of previous administration of experimental MTB vaccines within the past 6 months. 7) Sick and moribund individuals with Karnofsky score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with Severe COVID disease based on COVID Severity Scale and proportion of death due to Covid 19 disease Timepoint: 6 months post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of Hospital admission and ICU admission due to Covid-19 2. Proportion of participants in various Severity stages of Covid-19 (mild, moderate or severe) 3. Proportion of participants requiring hospital admission due to other respiratory febrile illness 4. Immunological outcomes in the sub study Timepoint: At 6 months post vaccination | — |
Countries
India
Contacts
Public ContactSrikanth Tripathy
ICMR-National Institute for Research in Tuberculosis
Outcome results
None listed