A randomised controlled trial of BCG vaccination at birth compared to at 6 weeks of age to investigate whether BCG provides protection against heterologous invasive infectious disease by stimulating the innate immune system

ondon School of Hygiene and Tropical Medicine (UK)0 个研究点目标入组 560 人开始时间: 2014年1月14日最近更新: 2020年7月6日

试验速览

•Neonates born to women delivering in Entebbe Grade B or Kisubi hospitals will be eligible for inclusion if:
•1. Mother consents for participation
•2. They reside in the study catchment areas
•3. Mothers are HIV negative (based on records available from antenatal care received during this pregnancy)
•4. The birth was sufficiently uncomplicated to allow the neonate to be discharged directly home from hospital with no infant admission or treatment for complications
•5. The neonate is of a gestational age and birth weight to allow discharge directly home from hospital (no requirement for supplemental oxygen or feeding)

•Neonates will be excluded from the study if:
•1. Cord blood is not obtained
•2. They have major congenital malformations
•3. The infant is clinically unwell, as judged by a midwife
•4. Known maternal tuberculosis (TB) or active TB within the family (based on direct questioning of mother during recruitment)
•5. Maternal or family member positive for any TB screening symptoms:
•5.1. Cough > 2 weeks
•5.2. Recent haemoptysis
•5.3.>3 kg weight loss in past month
•5.4. Recurrent fevers/chills or night sweats for the past 3 days or more

发起方

ondon School of Hygiene and Tropical Medicine (UK)