Immunologic TestsNCT01320137

Study in Allergic Adults to Support the Development of Immunological Assays

A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to develop and characterize immunological assays on blood samples. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Immunologic Tests
What is being tested?: Blood withdrawal
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesBelgium
Study dates: 31 Mar 2011to 11 May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
Healthy subjects (except the condition studied in the ALLERGY group).
A male or female between, and including 18 and 45 years of age at the time of study start.
Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group).
Subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for ALLERGY group).
A positive skin prick test response realised and/or a positive test for specific IgE against birch within the last 5 years (only for ALLERGY group).

Who cannot join

Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol.
Receipt of blood products 120 days prior to study visit.
Receipt of immunoglobulin 120 days prior to study visit.
Use of any investigational or non-registered product within 30 days preceding the study visit.
Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.

Show all 13Show fewer

Any confirmed or suspected autoimmune or inflammatory disorders.
Administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. Purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit.
Pregnant or lactating female.
Any past or current birch-specific immunotherapy (only for ALLERGY group).
Any allergic disease as established by medical history before study start (only for CONTROL group).
Family history of allergic diseases in the first degree family members (only for CONTROL group).

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

GSK Investigational Site
Ghent, 9000
GSK Investigational Site
La Louvière, 7100

Other trials in Belgium

About this study

Official title: A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays

The purpose of this study is to develop and characterize immunological assays on blood samples.

Read the detailed description

This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

Conditions: Immunologic Tests
Being tested: Blood withdrawal
Keywords: Immunological assay, Birch allergy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood withdrawalProcedure or surgery
Blood sampling

Study groups in NCT01320137
Study group	Role	What they receive
Allergy Group	Other	Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen. Receives: Procedure: Blood withdrawal
Control Group	Other	Subjects with ages ranging from 18-45 years and inclusive, with no known allergies. Receives: Procedure: Blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays.
Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation
Measured: At Day 0
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays.
Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.
Measured: At Day 0

Secondary outcomes (2)

Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)
Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation
Measured: At Day 0
Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition
Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.
Measured: At Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 201111 May 2011

First posted22 Mar 2011 (estimated)
Study start31 Mar 2011
Primary completion11 May 2011
Study completion11 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immunologic TestsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01320137
Sponsor's protocol ID: 115315
Status last verified: May 2017
First submitted: 21 Mar 2011
Last updated: 20 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays
ClinicalTrials.gov ID: NCT01320137
Acronym / sponsor ID: 115315
Conditions: Immunologic Tests
Keywords: Immunological assay, Birch allergy
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 31 Mar 2011 (actual)
Primary completion: 11 May 2011 (actual)
Study completion: 11 May 2011 (actual)
First posted: 22 Mar 2011 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to develop and characterize immunological assays on blood samples.

Detailed description

This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Allergy Group	Other	Procedure: Blood withdrawalSubjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
Control Group	Other	Procedure: Blood withdrawalSubjects with ages ranging from 18-45 years and inclusive, with no known allergies.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
Healthy subjects (except the condition studied in the ALLERGY group).
A male or female between, and including 18 and 45 years of age at the time of study start.
Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group).

Key exclusion criteria (13 listed)

Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol.
Receipt of blood products 120 days prior to study visit.
Receipt of immunoglobulin 120 days prior to study visit.
Use of any investigational or non-registered product within 30 days preceding the study visit.
Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood withdrawalBlood sampling	Procedure or surgery	Allergy Group, Control Group

Primary outcome

Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
Time frame: At Day 0
Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays. Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
Time frame: At Day 0
Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays. Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.

2 secondary outcomes

Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)
Time frame: At Day 0
Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition
Time frame: At Day 0

Results and safety

Results posted to the registry on 31 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allergy Group	40	40
Control Group	40	40

Primary outcome: Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines

Time frame: At Day 0. Number. Unit: Subjects

Measure	Allergy Group n = 10	Control Group n = 3
IL-13	7	1
IL-5	7	0

Population analysed: The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.

Primary outcome: Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition

Time frame: At Day 0. Number. Unit: Subjects

Measure	Allergy Group n = 10	Control Group n = 3
IL-13	6	0
IL-5	7	1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs related to study participation/concurrent GSK medication/vaccine reporting was done at Day 0. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allergy Group	0 of 40 (0%)	0 of 40 (0%)	Not reported
Control Group	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.

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 7 inclusion and 13 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines (time frame: At Day 0). The study lists 2 primary outcomes in all. 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 NCT01320137.

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 20 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.