Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: placebo; Drug: Histamine; Drug: AllerT1; Drug: AllerT2; Drug: AllerT3; Drug: AllerT4; Drug: AllerT5; Drug: mix of AllerT1-T2-T3; Drug: mix of AllerT4-T5

• Registration Number: NCT01719133
• Lead Sponsor: Anergis

Brief Summary

Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.

Detailed Description

The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter \> 4 mm with erythema)

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-31
• Last Update Submitted: 2012-10-31
• Study First Posted: 2012-11-01
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• history of allergy symptoms during previous birch pollen season
• positive skin prick test to birch pollen extract

Exclusion Criteria

• pregnancy
• uncontrolled asthma
• other significant clinical conditions or immune disorders
• subjects taking antihistamines or drugs with antihistamine activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Histamine	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	placebo	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	AllerT1	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	AllerT2	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	AllerT3	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	AllerT4	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	AllerT5	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	mix of AllerT1-T2-T3	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
All subjects	mix of AllerT4-T5	placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5

Primary Outcome Measures

Name	Time	Method
skin prick test reactivity	15 minutes

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland