Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01719133
First received: October 26, 2012
Last updated: October 31, 2012
Last verified: October 2012

October 26, 2012
October 31, 2012
February 2008
March 2008   (final data collection date for primary outcome measure)
skin prick test reactivity [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01719133 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
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.

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)

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Allergic Rhinitis
  • Drug: placebo
    saline solution
    Other Name: saline
  • Drug: Histamine
    positive control
    Other Name: Histamine solution
  • Drug: AllerT1
    synthetic peptide T1
    Other Name: AllerT1
  • Drug: AllerT2
    synthetic peptide T2
    Other Name: AllerT2
  • Drug: AllerT3
    synthetic peptide T3
    Other Name: AllerT3
  • Drug: AllerT4
    synthetic peptide T4
    Other Name: AllerT4
  • Drug: AllerT5
    synthetic peptide T5
    Other Name: AllerT5
  • Drug: mix of AllerT1-T2-T3
    mix of peptides T1, T2 and T3
    Other Name: AllerT
  • Drug: mix of AllerT4-T5
    mix T4-T5
    Other Name: mix T4-T5
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01719133
AN002
No
Anergis
Anergis
Not Provided
Principal Investigator: Francois Spertini, MD Centre Hospitalier Universitaire Vaudois
Anergis
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP