Bacille Calmette-Guérin (BCG) Vaccine and Atopy

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420705
• Other study ID #: 2011-BHP-LBW-BCG-atopy
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: December 27, 2011
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 9 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Eczema
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bandim

Sponsors (2)

Lead Sponsor	Collaborator
Bandim Health Project	Murdoch Childrens Research Institute

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin prick test	Skin prick tests to common aero and food allergen	Single observation at time of consent - DAY 1	No
Secondary	Symptoms of asthma	Symptoms of asthma using questions modified from ISAAC	Single observation at time of consent - DAY 1	No
Secondary	Symptoms of eczema	Eczema symptoms using questions modified from ISAAC	Single observation at time of consent - DAY 1	No
Secondary	Symptoms of food allergy	Symptoms of food allergy using questions modified from the Health Nuts study	Single observation at time of consent - DAY 1	No

External Links

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