Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality?

Summary

Bacillus Calmette-Guérin (BCG) vaccination is recommended at birth to protect against tuberculosis (TB) in countries with high TB burden. BCG is supplied in multidose vials with limited durability after reconstitution. In Guinea-Bissau, this has led to a practice of only opening a BCG vial at specific days, and only if sufficient children are present. Therefore, BCG vaccination is frequently delayed. Accumulating evidence indicates that BCG has beneficial effects on survival beyond the specific protection against tuberculosis, so called non-specific effects (NSEs).

The hypothesis of this study is that increasing the availability of BCG and vaccinating children at the first health-facility contact can reduce early infant non-accidental mortality by 25%.

In a cluster-randomised crossover trial, 23 health facilities (HFs) in three rural regions in Guinea-Bissau will be randomised to either continue with current practice (typically BCG vaccination once a week if a sufficient number of children are present for vaccination); or to offer additional BCG vaccines to make BCG available every day and open a vial of BCG if there is just one eligible child present. All children born in the three regions and registered during the study period, will be eligible for inclusion into the trial 1 day after birth. If consent is given by the mother, the child will be followed until day 42 after birth, when other vaccines are scheduled to be given. The primary outcome will be non-accidental mortality, secondary outcomes are non-accidental hospital admissions, non-accidental neonatal mortality and cost-effectiveness of making BCG available at the first health-facility contact.

Conditions

• Infant Mortality
• BCG

Interventions

DRUG

BCG vaccination at first health facility contact

Intradermal injection at first health facility contact: 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine in the left deltoid region. The strain supplied by the national vaccination programme is provided through UNICEF. Different strains are used interchangeably. The additional BCG vaccines provided through this study will be procured by the Bandim Health Project. Vaccines will be from the WHO list of prequalified vaccines and the same strain will be used in intervention and control health centres.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Bandim Health Project

  lead OTHER

Principal Investigators

• Ane B Fisker, MD, PhD · Bandim Health Project and University of Southern Denmark

• Andreas M Jensen, MSc · Bandim Health Project and University of Southern Denmark

• Julie O Vedel, MD · Bandim Health Project and University of Southern Denmark

• Sanne M Thysen, MD, PhD · Bandim Health Project and Center for Clinical Research and Prevention, Hospital of Bispebjerg and Frederiksberg

• Christine S Benn, MD,PhD,DMSc · Bandim Health Project and University of Southern Denmark

• Peter Aaby, DMSc · Bandim Health Project

• Aksel Jensen, MSc, PhD · Department of Public Health, University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

42 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-25

Primary Completion

2026-03-31

Completion

2026-07-31

Countries

• Guinea-Bissau

Study Locations