Bacille Calmette-Guérin (BCG) Vaccine and Atopy

This study has been completed.
Sponsor:
Collaborator:
Murdoch Childrens Research Institute
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01420705
First received: August 12, 2011
Last updated: December 27, 2011
Last verified: December 2011

August 12, 2011
December 27, 2011
October 2011
December 2011   (final data collection date for primary outcome measure)
Skin prick test [ Time Frame: Single observation at time of consent - DAY 1 ] [ Designated as safety issue: No ]
Skin prick tests to common aero and food allergen
Same as current
Complete list of historical versions of study NCT01420705 on ClinicalTrials.gov Archive Site
  • Symptoms of asthma [ Time Frame: Single observation at time of consent - DAY 1 ] [ Designated as safety issue: No ]
    Symptoms of asthma using questions modified from ISAAC
  • Symptoms of eczema [ Time Frame: Single observation at time of consent - DAY 1 ] [ Designated as safety issue: No ]
    Eczema symptoms using questions modified from ISAAC
  • Symptoms of food allergy [ Time Frame: Single observation at time of consent - DAY 1 ] [ Designated as safety issue: No ]
    Symptoms of food allergy using questions modified from the Health Nuts study
Same as current
Not Provided
Not Provided
 
Bacille Calmette-Guérin (BCG) Vaccine and Atopy
The Effect of Giving BCG Vaccine at Birth to Low Birth-weight Infants on Development of Allergy and Asthma in Childhood - Follow up of a Randomised Trial in Guinea-Bissau

The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.

Background: Prevalence of asthma and allergy is increasing worldwide, and the cause is unclear. Previous work by the Bandim Health Project and others has identified that infections and routine childhood vaccinations have an impact on the development of atopic sensitisation and allergic symptoms later in life. A number of these studies have found association between BCG vaccination and reduction in atopy and allergy. Only one randomised trial has been conducted of BCG vaccine to protect against allergy with inconclusive results. The present project provides the opportunity to follow-up children born low birth-weight who were randomised to receive BCG vaccine at birth or to receive BCG later in infancy as part of regular care.

Hypothesis:

  • Children given BCG vaccine at birth will have reduced prevalence of positive skin-prick test and allergic symptoms when compared with children who did not receive BCG at birth
  • Early BCG vaccination will be associated with reduced prevalence of positive skin prick test and allergic symptoms
  • Early DTP vaccination will be associated with increased prevalence of positive skin-prick tests and allergic symptoms

Objectives:

  • to examine the effects of environmental factors, including BCG, DTP and measles vaccines, on atopy (determined by skin-prick tests) and symptoms of asthma, eczema and food allergy
  • to examine the sex-differential effects of vaccination on atopy and allergic symptoms
  • to determine the association between faecal microbial diversity, atopy and food allergy

Methods: children previously enrolled in NCT00146302 will followed up at home (currently aged 3-9 years) and tested for atopic sensitisation with skin-prick tests and presence of allergic symptoms determined by questionnaire.

Sample size: 812 children from the Bandim Health Project study area were enrolled in the randomised trial. The investigators anticipate to be able to follow up approximately 487 of these children, which will have the power to detect a 30% difference in atopic sensitisation between groups.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

Faecal samples are collected for analyses of parasites and microbes

Probability Sample

Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau

  • Asthma
  • Eczema
  • Food Hypersensitivity
Not Provided
Low birth-weight cohort
Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area
Kiraly N, Benn CS, Biering-Sørensen S, Rodrigues A, Jensen KJ, Ravn H, Allen KJ, Aaby P. Vitamin A supplementation and BCG vaccination at birth may affect atopy in childhood: long-term follow-up of a randomized controlled trial. Allergy. 2013 Sep;68(9):1168-76. doi: 10.1111/all.12216. Epub 2013 Aug 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous enrolment in NCT00146302
  • Living within Bandim Health Project study area

Exclusion Criteria:

  • Children with known history of anaphylaxis
  • Children with skin infections or severe skin conditions for who SPT could not be reliably performed
  • Children currently taking anti-histamine medication
Both
3 Years to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT01420705
2011-BHP-LBW-BCG-atopy
No
Peter Aaby, Bandim Health Project
Bandim Health Project
Murdoch Childrens Research Institute
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
Bandim Health Project
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP