AsthmaNCT01420705
Bacille Calmette-Guérin (BCG) Vaccine and Atopy
An observational study of Asthma and Eczema, run by Bandim Health Project at 1 site in Guinea-Bissau.
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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Asthma, Eczema, Food Hypersensitivity
- How many people
- 487 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Oct 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau
Who may be able to join
- Previous enrolment in NCT00146302
- Living within Bandim Health Project study area
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Asthma, Eczema, Food Hypersensitivity
- Keywords
- Bacille Calmette-Guérin, DTP, Vaccination, Allergy, Atopy, Guinea-Bissau
- Medical subject headings
- Asthma, Eczema, Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low birth-weight cohort | Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin prick test
Skin prick tests to common aero and food allergen
Measured: Single observation at time of consent - DAY 1
Secondary outcomes (3)
Symptoms of asthma
Symptoms of asthma using questions modified from ISAAC
Measured: Single observation at time of consent - DAY 1
Symptoms of eczema
Eczema symptoms using questions modified from ISAAC
Measured: Single observation at time of consent - DAY 1
Symptoms of food allergy
Symptoms of food allergy using questions modified from the Health Nuts study
Measured: Single observation at time of consent - DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 487 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Murdoch Childrens Research Institute
- Investigators
- Peter Aaby, DMSc, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420705
- Sponsor's protocol ID
- 2011-BHP-LBW-BCG-atopy
- Status last verified
- Dec 2011
- First submitted
- 12 Aug 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23991838
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01420705
- Acronym / sponsor ID
- 2011-BHP-LBW-BCG-atopy
- Conditions
- Asthma, Eczema, Food Hypersensitivity
- Keywords
- Bacille Calmette-Guérin, DTP, Vaccination, Allergy, Atopy, Guinea-Bissau
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (estimated)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Murdoch Childrens Research Institute
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low birth-weight cohort | – | –Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau
Key inclusion criteria (2 listed)
- Previous enrolment in NCT00146302
- Living within Bandim Health Project study area
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin prick test
Time frame: Single observation at time of consent - DAY 1
Skin prick tests to common aero and food allergen
3 secondary outcomes
Symptoms of asthma
Time frame: Single observation at time of consent - DAY 1
Symptoms of eczema
Time frame: Single observation at time of consent - DAY 1
Symptoms of food allergy
Time frame: Single observation at time of consent - DAY 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 23991838Kiraly 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Aaby, DMSc principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Eczema, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin prick test (time frame: Single observation at time of consent - DAY 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.