Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?

NCT00146302 | Completed Phase 4

• 3 other identifiers: ICA4-CT-2002-10053LBWICA4-CT-2002-10053#6-FY04-51
• Study Type: interventional
• Target: 2,320
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks. Due to difficulties in establishing the correct gestational age, the vaccination policy for BCG in many developing countries is defined by birth weight rather than by gestational maturity. In the study area, low birth weight (LBW) infants (\< 2500 g) are not supposed to be vaccinated at birth; instead the mother is asked to return for vaccination when the child has gained sufficient weight. BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of early vaccination of LBW children for adverse events, purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity, and mortality in a randomised prospective study of BCG vaccination at birth versus later (according to policy) among children 19 months of age in Guinea-Bissau. The hypothesis is that BCG vaccination of low birth weight (LBW) children at birth reduces infant mortality of this high-risk group by 25%.

Conditions

Tuberculosis

Keywords

Non-specific effects of vaccines; Infant mortality; Morbidity; Low income country; BCG; Vaccine policy; immunisation; Low birth weight; Tuberculin; Mortality

Outcome Measures

Primary Outcomes (3)

• Mortality until 12 months of age

• Hospitalisations until 12 months of age

• Adverse events within 12 months after intervention

Secondary Outcomes (3)

• Tuberculin reaction 2 and 6 months after intervention

• BCG scar reaction 2 and 6 months after intervention

• Assessment of antibody and cellular immune responses following intervention

Interventions

Bacille Calmette Guerin (BCG) BIOLOGICAL

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Must weigh less than 2500 g at birth
• Must be able to nurse
• Must be healthy enough to be discharged from the hospital

You may not qualify if:

• Overt illness
• Malformation

Sponsors & Collaborators

• Bandim Health Project: lead
• International Cooperation with Developing Countries: collaborator
• March of Dimes: collaborator
• Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland: collaborator
• Medical Research Council Unit, The Gambia: collaborator

Study Sites (1)

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Location

Related Publications (6)

• 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

• Jensen KJ, Biering-Sorensen S, Ursing J, Kofoed PL, Aaby P, Benn CS. Seasonal variation in the non-specific effects of BCG vaccination on neonatal mortality: three randomised controlled trials in Guinea-Bissau. BMJ Glob Health. 2020 Mar 5;5(3):e001873. doi: 10.1136/bmjgh-2019-001873. eCollection 2020.

  PMID: 32201619 DERIVED

• Schaltz-Buchholzer F, Biering-Sorensen S, Lund N, Monteiro I, Umbasse P, Fisker AB, Andersen A, Rodrigues A, Aaby P, Benn CS. Early BCG Vaccination, Hospitalizations, and Hospital Deaths: Analysis of a Secondary Outcome in 3 Randomized Trials from Guinea-Bissau. J Infect Dis. 2019 Jan 29;219(4):624-632. doi: 10.1093/infdis/jiy544.

  PMID: 30239767 DERIVED

• Biering-Sorensen S, Jensen KJ, Monterio I, Ravn H, Aaby P, Benn CS. Rapid Protective Effects of Early BCG on Neonatal Mortality Among Low Birth Weight Boys: Observations From Randomized Trials. J Infect Dis. 2018 Feb 14;217(5):759-766. doi: 10.1093/infdis/jix612.

  PMID: 29216358 DERIVED

• Biering-Sorensen S, Andersen A, Ravn H, Monterio I, Aaby P, Benn CS. Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial. BMC Pediatr. 2015 Sep 28;15:137. doi: 10.1186/s12887-015-0452-2.

  PMID: 26416147 DERIVED

• Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.

  PMID: 22189537 DERIVED

MeSH Terms

Conditions

Tuberculosis; Infant Death

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Aaby

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2005
• First Posted: September 7, 2005
• Study Start: November 1, 2002
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

GU (1)