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
  Purpose

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.


Condition
Asthma
Eczema
Food Hypersensitivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Faecal samples are collected for analyses of parasites and microbes


Estimated Enrollment: 487
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Low birth-weight cohort
Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420705

Locations
Guinea-Bissau
Bandim Health Project
Bandim, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Murdoch Childrens Research Institute
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
  More Information

Additional Information:
No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Aaby, Bandim Health Project
ClinicalTrials.gov Identifier: NCT01420705     History of Changes
Other Study ID Numbers: 2011-BHP-LBW-BCG-atopy
Study First Received: August 12, 2011
Last Updated: December 27, 2011
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Bacille Calmette-Guérin
DTP
Vaccination
Allergy
Atopy
Guinea-Bissau

Additional relevant MeSH terms:
Asthma
Hypersensitivity
Food Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014