Bacille Calmette-Guérin (BCG) Vaccine and Atopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420705
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : December 29, 2011
Murdoch Childrens Research Institute
Information provided by:
Bandim Health Project

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.

Condition or disease
Asthma Eczema Food Hypersensitivity

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.


  • 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


  • 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.

Study Type : Observational
Estimated Enrollment : 487 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Low birth-weight cohort
Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area

Primary Outcome Measures :
  1. Skin prick test [ Time Frame: Single observation at time of consent - DAY 1 ]
    Skin prick tests to common aero and food allergen

Secondary Outcome Measures :
  1. Symptoms of asthma [ Time Frame: Single observation at time of consent - DAY 1 ]
    Symptoms of asthma using questions modified from ISAAC

  2. Symptoms of eczema [ Time Frame: Single observation at time of consent - DAY 1 ]
    Eczema symptoms using questions modified from ISAAC

  3. Symptoms of food allergy [ Time Frame: Single observation at time of consent - DAY 1 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01420705

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Aaby, Bandim Health Project Identifier: NCT01420705     History of Changes
Other Study ID Numbers: 2011-BHP-LBW-BCG-atopy
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Bandim Health Project:
Bacille Calmette-Guérin

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