Adverse Events in Infants Following BCG Vaccination ver 1.0
Research type
Research Study
Full title
Adverse Events in Infants Following Bacillus Calmette-Guérin Vaccination
IRAS ID
186402
Contact name
Elizabeth Whittaker
Contact email
Sponsor organisation
Imperial College, London
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
Newborn infants in the UK who are at high risk of tuberculosis exposure receive Bacillus Calmette-Guérin (BCG) vaccination at birth. A small but significant proportion of BGC-vaccinated infants develop vaccine-related adverse events; the current literature reports wide-ranging estimates for their incidence.
We now know that almost all children who develop severe disseminated BCG disease have an underlying immunodeficiency. However, it remains unclear if infants who develop less severe complications possess more subtle defects of the immune system.
We aim to describe the incidence of adverse events in infants following BCG vaccination. We also plan to improve our understanding of the immune response to BCG in young infants with immature immune systems via laboratory testing of blood samples for RNA expression.
We will work in close collaboration with the Northwest London Clinical Research Network (NWLCRN) and will work in a number of selected GP practices in Northwest London. Over a 12 month period, all BCG-vaccinated children receiving their routine 2, 3 and 4 month vaccinations will be evaluated for the presence of axillary lymphadenopathy. If lymphadenopathy is present they will be invited to join the study. Children with any BCG-related adverse event will also be recorded.
We expect this study to enhance our knowledge of the immature immune system in young infants and specifically its response to BCG vaccine. We also anticipate an improved understanding of the frequency of adverse events following BCG vaccination.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0311
Date of REC Opinion
16 May 2017
REC opinion
Further Information Favourable Opinion