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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01420705
Other study ID # 2011-BHP-LBW-BCG-atopy
Secondary ID
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


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
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