To study if BCG vaccinated individuals have enhanced COVID-19 antibodies after COVID-19 vaccination.
- Registration Number
- CTRI/2022/10/046542
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Children who have received COVID-19 vaccination with 2nd dose between 2 to 3 months from the date of enrolment.
Group 1: Participants who have received BCG vaccine at birth or infancy.
Operation definition of BCG vaccinated children in the primary objective: presence of BCG scar over left arm.
A separate exploratory analysis will also be done which will include children without BCG scar who have a positive history of BCG vaccination taking into consideration the cases of scar negative BCG vaccination
Group 2: Participants who have not received BCG vaccine at birth or infancy.
1)Known active case or a history of Mycobacterium tuberculosis infection.
2)Children with diagnosed or suspected immunodeficiency states-primary or secondary.
3)Children with suspected or confirmed malignancy.
4)Children with history of blood transfusion, intravenous immunoglobin, steroids or immunosuppressive drugs in the last three months.
5)Fever within past 72 hours.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method