Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen (AN003)

Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen

Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen

Study Overview

• Status: Terminated
• Conditions: Allergy; Allergic Rhinitis
• Intervention / Treatment: Drug: AllerT SC; Drug: Placebo SC; Drug: AllerT ID; Drug: Placebo ID

Detailed Description

In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1005
    • Lausanne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
• Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT

Exclusion Criteria:

• received immunotherapy against any allergen within 3 years before the start of the study.
• symptomatic to perennial allergens or active seasonal allergy during the trial.
• non controlled asthma (peak flow lower than 30% of predicted value).
• history of any severe medical condition able to influence the course of the study
• Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
• Subjects under immunosuppressive medication.
• Pregnant or lactating women or women willing or intending to become pregnant during the study.
• Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AllerT SC; AllerT subcutaneous injections	Drug: AllerT SC; AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram); Other Names: AllerT subcutaneous injections
PLACEBO_COMPARATOR: Placebo SC; placebo subcutaneous injections	Drug: Placebo SC; Placebo subcutaneous injections on days 1, 7, 14, 21 and 56; Other Names: Placebo subcutaneous injections
EXPERIMENTAL: AllerT ID; AllerT intra-dermal injections	Drug: AllerT ID; AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram); Other Names: Aller T intra-dermal injections
PLACEBO_COMPARATOR: Placebo ID; placebo intra-dermal injections	Drug: Placebo ID; Placebo intra-dermal injections on days 1, 7, 14, 21 and 56; Other Names: Placebo intra-dermal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)	84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in blood levels of specific IgG4 and IgE	blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012	after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months
change from baseline in nasal provocation tests	nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment	84 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of the Mini-RQLQ Quality-of-life questionnaire	weekly questionnaires are filled in by the subjects during April 2009 at the time of the birch pollen season in the trial center area	4 weeks during April 2009

Collaborators and Investigators

• Sponsor: Anergis
• Investigators: Principal Investigator: Francois Spertini, MD, University of Lausanne Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (ESTIMATE): November 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Allergy; Immunotherapy; Birch Pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: AN003