BALLOON-T V1.0
Research type
Research Study
Full title
Investigating Trained Immunity and T cell Responses in Samples from Preterm-born Infants following Bactek MV130 Therapy
IRAS ID
239625
Contact name
Sailesh Kotecha
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Babies born early or prematurely have under-developed lungs. Many will need help with their breathing after birth, sometimes for several weeks. Some babies will go on to have lifelong lung problems.
Like all babies, premature babies will get infections which they generally deal with well. The main problem is that over half will get chest infections (“pneumonia”, commonly due to viruses) which will further damage the lungs.
There are very few treatments available to prevent viral chest infections except against the virus called RSV (Respiratory Syncytial Virus).
In another study called BALLOON, we want to use a new approach to prepare the babies’ immune system to fight chest infections. Bactek (MV130) is an under the tongue spray containing harmless dead bacteria, so it works like a vaccine. The dead bacteria should help the baby build a strong immune system, preventing further damage to the lungs by helping to fight chest infections. Studies show that Bactek decreases chest infections and wheezing safely in children and babies. Because only some premature babies have been studied so far, a larger study is needed to show if Bactek works in premature babies born at ≤29+6 weeks of gestation.
We will use samples collected in BALLOON to help us understand how Bactek impacts on the immune system by studying blood samples and nose or throat swabs collected from the babies who have been given Bactek or a placebo (dummy medicine) from close to their due date until they are one year from their due date. We think 150-175 parents or guardians will consent for blood to be taken (to ensure that 3 samples per infant for 100 infants are available) and 542 parents or guardians will collect nose or throat swabs.
REC name
North West - Preston Research Ethics Committee
REC reference
25/NW/0177
Date of REC Opinion
10 Jun 2025
REC opinion
Favourable Opinion