Effect of maternal TB infection on infant response to BCG immunisation
Research type
Research Study
Full title
The impact of maternal infection with Mycobacterium tuberculosis on the infant response to BCG immunisation
IRAS ID
162186
Contact name
Hazel M Dockrell
Contact email
Sponsor organisation
London School of Hygiene and Tropical Medicine
Clinicaltrials.gov Identifier
ITCRZB2310, LSHTM project grant code
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Infant immune responses to BCG vaccination and the effect of maternal tuberculosis infection: A comparison with Uganda
Tuberculosis (TB) affects millions of people worldwide. The vaccine that protects against TB, BCG, does not work very well in tropical countries which is often where the TB problem is worst. BCG does work well in the UK where it is given to babies and protects against TB in childhood. An important question for researchers who hope to make better vaccines for TB is why does BCG work in some countries but not in others? One theory suggests that babies born from mothers infected with TB bacteria do not respond well to BCG vaccination.
The aim of this Medical Research Council-funded research study is to look in detail at the immune response made by new-born infants in the UK who receive the BCG vaccination and whose mothers are not expected to be infected with TB, and compare these responses with babies born in Uganda where TB infection is much more common and where BCG vaccination does not work as well.
Mothers and babies born at hospital where the BCG vaccine is universally administered to all infants would be eligible to participate. The study site would be an NHS trust where BCG is administered to new-born babies including hospital and any community clinics where blood sample appointments would take place. We are aiming to recruit 100 mother and infant pairs and expect that this will take approximately two years. Pregnant women will be initially contacted to obtain consent then again post-natally to arrange an infant blood sample appointments which will be between 4 and 10 weeks of age then again at 12 months. A small blood sample (approximately 1 teaspoon) will be taken from the mother (1st appointment only) and from the baby.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/0048
Date of REC Opinion
27 Feb 2015
REC opinion
Further Information Favourable Opinion