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

Allergic Rhinitis Clinical Trial

— AN003  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01728519
• Other study ID #: AN003
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 9, 2012
• Last updated: November 13, 2012
• Start date: August 2008
• Est. completion date: July 2012

Study information

• Verified date: November 2012
• Source: Anergis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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),

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: July 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergy

Intervention

Drug:
• AllerT SC
AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
• AllerT ID
AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
• Placebo SC
Placebo subcutaneous injections on days 1, 7, 14, 21 and 56
• Placebo ID
Placebo intra-dermal injections on days 1, 7, 14, 21 and 56

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Anergis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No