Extrait

Background and study aims This study aims to find out whether Bacillus-Calmette Guerin (BCG), the vaccine normally given to protect against tuberculosis, might also be able protect babies against other infections. One study in premature babies in Guinea-Bissau suggests that this might be the case, but we do not know if this wider protection also occurs in other countries and in babies born at the right time. It is also not yet known how BCG vaccination might protect against diseases other than tuberculosis. In this study we are aiming to see whether BCG vaccination can protect healthy Ugandan babies against diseases other than tuberculosis, and try to find an explanation as to how BCG produces this protection. Who can participate? Healthy babies born in one of the two study hospitals (Entebbe Grade B and Kisubi Hospitals) in Uganda. What does the study involve? Mothers presenting in labour to one of the study hospitals will be approached to ask whether they would like to be involved in the study. If they agree and the baby is born healthy, the mother will be asked questions regarding her living circumstances and health, and details of the infant's birth will be recorded. A sample of blood will be taken from the umbilical cord after it has been detached from the baby. The mother will choose an envelope at random which will say whether the baby has been allocated to receive BCG vaccination at birth or at 6 weeks of age. The baby will be vaccinated immediately if in the 'at birth' group. All babies will receive their other immunisations at birth as normal. In the first 10 weeks of the baby's life the mothers will be asked to return to the clinic with the baby for two further blood samples (less than half a teaspoon of blood each), all routine immunisations, and BCG vaccination at 6 weeks of age if it was not given at birth. Each time the baby is seen at the clinic it will be reviewed by a doctor to check that it remains well. Mothers will also be contacted by telephone weekly to double check the health of the baby. Participation in the study finishes after the baby has reached 10 weeks of age. What are the possible benefits and risks to the participants? All participants in the study will benefit from free, open access to medical care. We will also make sure that they receive all of their routine vaccinations at the correct time, which does not always happen in Uganda. Mothers will also be reimbursed their travel costs for each scheduled clinic visit (10,000 Ugandan Shillings - £2.50). The main risk to participants is of 6 weeks of possible exposure to tuberculosis before BCG vaccination. This risk will only apply to the half of infants allocated to receive BCG vaccination at 6 weeks of age. We believe that this risk is extremely small because it is very unusual for infants to contract tuberculosis this early in life. It is also no higher risk than is undergone by more than half of Ugandan babies currently, who do not receive BCG vaccination before 6 weeks of age. There is also some evidence that delaying BCG vaccination may improve the protection that the vaccine gives against tuberculosis, so these babies may have some benefits from receiving BCG vaccination at 6 weeks of age. We will monitor all the infants very closely to ensure there is no disadvantage to the infants in either group. The study will be stopped early if one group appears to be at higher risk than the other. Where is the study run from? The study will recruit infants from Entebbe Grade B and Kisubi Hospitals in Uganda. The main research clinic where infants will be seen for follow-up will be at the Entebbe Mother and Baby Study Clinic, which is attached to Entebbe Grade B hospital. The study is co-ordinated through the Medical Research Council/Uganda Virus Research Institute on AIDS (Uganda), where the laboratory work will be conducted, and the London School of Hygiene and Tropical Medicine (UK). When is the study starting and how long is it expected to run? We aim to start recruiting babies in mid-march 2014. Recruitment and follow-up is likely to continue for 15 months, ending in June 2015. Laboratory analysis will continue for a further 6 months. Who is funding the study? The Wellcome Trust (UK). Who is the main contact? Dr Sarah Prentice [email protected]

Critère d'inclusion

• All cause invasive infectious disease/neonatal sepsis

Liens

• ictrp
• isrctn