Bacille Calmette-Guérin (BCG) Vaccine and Atopy

NCT01420705 | Completed

• 1 other identifier: 2011-BHP-LBW-BCG-atopy
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Eczema; Food Hypersensitivity

Keywords

Bacille Calmette-Guérin; DTP; Vaccination; Allergy; Atopy; Guinea-Bissau

Outcome Measures

Primary Outcomes (1)

• Skin prick test

  Skin prick tests to common aero and food allergen

  Single observation at time of consent - DAY 1

Secondary Outcomes (3)

• Symptoms of asthma

  Single observation at time of consent - DAY 1

• Symptoms of eczema

  Single observation at time of consent - DAY 1

• Symptoms of food allergy

  Single observation at time of consent - DAY 1

Study Arms (1)

Low birth-weight cohort

Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandim Health Project: lead
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Bandim Health Project

Bandim, Guinea-Bissau

Location

Related Publications (1)

• Kiraly N, Benn CS, Biering-Sorensen 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.

  PMID: 23991838 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal samples are collected for analyses of parasites and microbes

MeSH Terms

Conditions

Asthma; Eczema; Food Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Peter Aaby, DMSc

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 22, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

GU (1)