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

Study Overview
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Brief Summary
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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

Detailed Description
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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),

Official Title
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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

Conditions
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Allergic Rhinitis, Allergy

Intervention / Treatment
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* Drug: AllerT SC
* Drug: AllerT ID
* Drug: Placebo SC
* Drug: Placebo ID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AllerT SC<br>AllerT subcutaneous injections | Drug: AllerT SC<br>* AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)<br>* Other names: AllerT subcutaneous injections;|
| Placebo Comparator: Placebo SC<br>placebo subcutaneous injections | Drug: Placebo SC<br>* Placebo subcutaneous injections on days 1, 7, 14, 21 and 56<br>* Other names: Placebo subcutaneous injections;|
| Experimental: AllerT ID<br>AllerT intra-dermal injections | Drug: AllerT ID<br>* AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)<br>* Other names: Aller T intra-dermal injections;|
| Placebo Comparator: Placebo ID<br>placebo intra-dermal injections | Drug: Placebo ID<br>* Placebo intra-dermal injections on days 1, 7, 14, 21 and 56<br>* Other names: Placebo intra-dermal;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Birch Pollen, Immunotherapy