Clinical Trial: Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial

Brief Summary: The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural setting.

Detailed Summary:

Background: BCG and oral polio vaccines (OPV) at birth are associated with beneficial non-specific effects, reducing neonatal mortality by more than what can be explained by prevention of the target diseases. BCG is recommended at birth, but is often given much later, especially in rural areas. In two RCTs in Guinea-Bissau, BCG-at-birth reduced neonatal mortality in low birthweight (<2500g; LBW) children by 48% (95%CI: 18-67%) and in children with a birthweight >2500g (NBW), OPV+BCG vs BCG was associated with a 32% (95%CI: 0-55%) lower mortality.

WHO recommends home visits shortly after birth to reduce mortality, but vaccinations are not normally provided. If the vaccines indeed have profound effects on innate immunity and neonatal mortality in both LBW and NBW children many lives could be saved if BCG and OPV was provided earlier. We will cluster randomise villages to home visits with and without vaccinations. All children participating in the study will be offered routine vaccines at village visits by the BHP team. Thereby the study will provide earlier vaccination for all children.

Hypothesis: BCG+OPV at birth provided at village visits shortly after birth will reduce early infant mortality by 40%.

Methods: The study will be conducted in Biombo, Oio and Cacheu in Guinea-Bissau, where home visits are not yet implemented. At two-monthly visits by the BHP team all registered pregnant women will be offered to participate in the study. Community key informants will communicate information on births in the village to the BHP study team, and the study nurse will visit every new-born child shortly after a CKI calls, if possible on the same day. Villages will be randomised to receive immediate vaccination of their children shortly after birth or at the first visit by the BH
Sponsor: Bandim Health Project

Current Primary Outcome: Mortality [ Time Frame: 6 weeks after birth ]

Mortality between the home visit and, the next two-monthly visit by BHP where all children will be offered BCG vaccination or the date of the first pentavalent vaccine. Follow-up time will be censored at OPV campaigns.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality by birth weight [ Time Frame: 6 weeks after birth ]
  • Adverse events [ Time Frame: 4 months after birth ]
    At the two first visits after enrolment in the study, all children will be invited to the vaccination post, where the BHP nurse will examine the BCG vaccination site, axillary lymph glands and measure temperature for all children to assess possible adverse effects of the BCG vaccination.
  • Consultations [ Time Frame: 1 year after birth ]
  • Hospital admission [ Time Frame: 1 year after birth ]
  • Growth [ Time Frame: 1 year after birth ]
    Measurement of mid-upper-arm circumference
  • Growth [ Time Frame: 6 weeks after birth ]
    Weight of the child
  • BCG scarring [ Time Frame: 1 year after birth ]
  • Cause specific mortality [ Time Frame: 6 weeks after birth ]
    For every death a verbal autopsy will be made
  • Cost-effectiveness analysis of providing BCG at home-visits [ Time Frame: 6 weeks after birth ]


Original Secondary Outcome: Same as current

Information By: Bandim Health Project

Dates:
Date Received: July 20, 2015
Date Started: November 2015
Date Completion: July 2020
Last Updated: February 1, 2017
Last Verified: February 2017