Extrait

Background and study aims Bacillus-Calmette Guerin (BCG) vaccination is given to babies at birth to protect them against tuberculosis (TB). There is some evidence that this vaccination might also protect infants against other infections, but it is not known how this might happen. Our aim is to find out whether BCG vaccination might decrease iron levels in the blood stream. As iron is very important for the growth of many infectious diseases, such a reduction might limit the growth of these organisms. This might therefore provide babies with protection against many serious diseases. This study is a small initial study to compare the levels of iron and its controlling hormone in BCG vaccinated and unvaccinated babies in the first few days of life. The results of this study will be used to design future research. Who can participate? Any healthy baby born and registered in the study area (West Kiang, The Gambia) is free to participate. They can only be included in the study if they are seen within the first 24 hours of life and consent is gained from the mother. What does the study involve? Babies participating in the study will be randomly assigned to receive BCG vaccination either on the first day of life or delayed to 24-96 hours of age. All infants will have two blood tests taken, one immediately after birth (before any vaccinations are given) and a second at either 24 or 72 hours after the first blood test. Any child receiving delayed BCG vaccination will then be vaccinated following their second blood test. All infants will receive all other routine vaccinations as normal at birth. A medical professional will clinically review all infants at the time of their blood tests. Any child deemed to be unwell will be referred to the research clinic for treatment. Each infant’s study involvement will be complete by 4 days of age. The blood samples taken from each infant will be tested for markers of iron status, as well as for levels of the hormone regulating iron status. What are the possible benefits and risks of participating? Participants benefit from early review by trained medical professionals in their homes. Any unwell child will be transferred directly to receive medical attention free of charge. Participants also benefit by receiving vaccinations earlier than they otherwise would. There is a very small increased risk of tuberculosis infection in infants who have delayed BCG vaccination compared to those that receive it on the first day of life. This is minimised by excluding infants born into families with a known case of active TB. The very short delay in vaccination also makes the risk of infection minimal. The taking of two blood samples from participants is likely to cause a small amount of discomfort. This will be minimised by comfort measures such as breast-feeding. Blood sampling also poses a potential risk of introducing infection to the baby. This will be minimised by making sure all procedures are carried out in a sterile way. The volume of blood taken at each of the blood tests is well within recommended guidelines and should not pose any risk to infants. Where is the study run from? This study is run from the MRC-Keneba field station in The Gambia. When is the study starting and how long is it expected to run for? The study started in June 2013 and is expected to last for 6 months. It will continue until 80 infants (40 male and 40 female) have been recruited. Who is funding the study? The study is funded by the Medical Research Council, UK. Who is the main contact? Dr Sarah Prentice, [email protected] Dr Sophie Moore, [email protected] Dr Rita Wegmuller, [email protected]

Critère d'inclusion

• The effect of BCG vaccination on serum iron status in neonates

Liens

• ictrp
• isrctn