Skip to content

To study if BCG vaccinated individuals have enhanced COVID-19 antibodies after COVID-19 vaccination.

Assessment of Serological Response to COVID-19 Vaccination and its Association with Exposure to BCG Vaccine: A Comparative Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046542
Enrollment
70
Registered
2022-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Comparison of COVID-19 antibody titres between BCG vaccinated & unvaccinated groupsTimepoint: at baseline,3 and 6 months

Secondary

MeasureTime frame
comparison of T cell marker CD45RO in both BCG vaccinated & unvaccinated children comparison of covid 19 antibody titres in children with low & normal BMITimepoint: At baseline

Countries

India

Contacts

Public ContactDr Pratibha

UCMS and GTB Hospital

manish_2710@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026