Clinical trial NCT01420705: Bacille Calmette-Guérin (BCG) Vaccine and Atopy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Eczema
Food Hypersensitivity
Keywords: Bacille Calmette-Guérin
DTP
Vaccination
Allergy
Atopy
Guinea-Bissau
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
Collaborators: name: Murdoch Childrens Research Institute
First posted: 2011-08-22
Enrollment: 487
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau

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.

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 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

Primary outcomes:
measure: Skin prick test
timeFrame: Single observation at time of consent - DAY 1
Secondary outcomes:
measure: Symptoms of asthma
timeFrame: Single observation at time of consent - DAY 1
measure: Symptoms of eczema
timeFrame: Single observation at time of consent - DAY 1
measure: Symptoms of food allergy
timeFrame: Single observation at time of consent - DAY 1
Other outcomes:
Locations:
city: Bandim
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiraly N, Benn CS, Biering-Sorensen S, Rodrigues A, Jensen KJ, Ravn H, Allen KJ, Aaby P. Vitamin A supplementation and BCG vaccination at birth may affect atopy in childhood: long-term follow-up of a randomized controlled trial. Allergy. 2013 Sep;68(9):1168-76. doi: 10.1111/all.12216. Epub 2013 Aug 31.