A Randomized Trial of Providing BCG Vaccination Immediately

NCT01989026 | Terminated Phase 4 DMC

• 1 other identifier: CVK-2013-1303771
• Study Type: interventional
• Target: 3,361
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This effect cannot be explained by prevention of tuberculosis, which is very rare among infants. The protective effect of BCG vaccination is seen already within the first week. It seems that BCG provides a non-specific beneficial immune modulation - thereby reducing overall mortality. Mortality is very high among newborns admitted to the neonatal intensive care unit. If BCG has immediate beneficial effects on the immune system, vaccinating children with BCG as early as possible may save lives. The investigators will test this hypothesis in a randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge (usual practice).

Conditions

Early Neonatal Mortality

Keywords

BCG; non-specific effects; neonatal mortality; vaccines

Outcome Measures

Primary Outcomes (1)

• Mortality

  Participants will be followed for the duration of hospital stay, an expected average of 6 days.

Secondary Outcomes (3)

• Duration of admission

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• Cause of death

  Participants will be followed for the duration of hospital stay, an expected average of 6 days.

• Growth

  Participants will be followed for the duration of hospital stay, an expected average of 6 days.

Study Arms (2)

BCG at admission to NICU

ACTIVE COMPARATOR

These children will receive the BCG (and OPV) vaccines at admission to the Neonatal Intensive Care Unit (NICU).

Biological: BCG

BCG at discharge (as usual)

NO INTERVENTION

These children will only receive the BCG (and OPV) vaccines at discharge, as per current standard of care.

Interventions

BCG BIOLOGICAL

BCG at admission to NICU

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children admitted to the neonatal intensive care unit

You may not qualify if:

• Birth weight\<1250 g
• Apgar score\<2
• Moribund children and children with gross malformations

Sponsors & Collaborators

• Bandim Health Project: lead

Study Sites (1)

Maternity Ward, National Hospital Simao Mendes

Bissau, 1004, Guinea-Bissau

Location

Related Publications (2)

• Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.

  PMID: 21673035 BACKGROUND

• Schaltz-Buchholzer F, Berendsen M, Roth A, Jensen KJ, Bjerregaard-Andersen M, Kjaer Sorensen M, Monteiro I, Aaby P, Stabell Benn C. BCG skin reactions by 2 months of age are associated with better survival in infancy: a prospective observational study from Guinea-Bissau. BMJ Glob Health. 2020 Sep;5(9):e002993. doi: 10.1136/bmjgh-2020-002993.

  PMID: 32978212 DERIVED

Related Links

• Bandim Health Project homepage

Study Officials

• Morten Bjerregaard-Andersen, MD, PhD

  Research Center for Vitamins and Vaccines

  PRINCIPAL INVESTIGATOR

• Christine Stabell Benn, MD, PhD, DMSc

  Research Center for Vitamins and Vaccines

  STUDY DIRECTOR

• Peter Aaby, Prof, DMSc

  Bandim Health Project

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

GU (1)