Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

October 31, 2012 updated by: Anergis

Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
Drug: placebo
saline solution
Other Names:
  • saline
Drug: Histamine
positive control
Other Names:
  • Histamine solution
Drug: AllerT1
synthetic peptide T1
Drug: AllerT2
synthetic peptide T2
Drug: AllerT3
synthetic peptide T3
Drug: AllerT4
synthetic peptide T4
Drug: AllerT5
synthetic peptide T5
Drug: mix of AllerT1-T2-T3
mix of peptides T1, T2 and T3
Other Names:
  • AllerT
Drug: mix of AllerT4-T5
mix T4-T5
Other Names:
  • mix T4-T5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin prick test reactivity
Time Frame: 15 minutes
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anergis

Investigators

  • Principal Investigator: Francois Spertini, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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