Trial Outcomes & Findings for Study in Allergic Adults to Support the Development of Immunological Assays (NCT NCT01320137)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

At Day 0

Results posted on

2017-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Allergy Group Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study in Allergic Adults to Support the Development of Immunological Assays

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allergy Group n=40 Participants Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group n=40 Participants Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.	Total n=80 Participants Total of all reporting groups
Age, Continuous	30.1 Years STANDARD_DEVIATION 7.44 • n=5 Participants	28.6 Years STANDARD_DEVIATION 6.92 • n=7 Participants	29.35 Years STANDARD_DEVIATION 7.18 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: 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.

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

Outcome measures

Outcome measures
Measure	Allergy Group n=10 Participants Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group n=3 Participants Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines IL-13	7 Subjects	1 Subjects
Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines IL-5	7 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 0

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Allergy Group n=10 Participants Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group n=3 Participants Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition IL-5	7 Subjects	1 Subjects
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition IL-13	6 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Day 0

Population: 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.

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

Outcome measures

Outcome measures
Measure	Allergy Group n=10 Participants Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group n=3 Participants Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)	8 Subjects	3 Subjects

SECONDARY outcome

Timeframe: At Day 0

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Allergy Group n=10 Participants Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.	Control Group n=3 Participants Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition	8 Subjects	2 Subjects

Adverse Events

Allergy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER