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NCT Number: NCT01420705

Bacille Calmette-Guérin (BCG) Vaccine and Atopy

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.

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Key information

Conditions

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

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandim Health Project

Bandim, Guinea-Bissau

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skin prick test

    Time frame: Single observation at time of consent - DAY 1

    Skin prick tests to common aero and food allergen

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Collaborators

  • Murdoch Childrens Research Institute

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 22, 2011
Registry last updated
Dec 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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