Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for the Immunological and Histological Evaluation of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v1-FV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841516
• Other study ID #: AL0801rB
• Secondary ID: 2008-006258-16
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2009
• Last updated: November 7, 2013
• Start date: December 2007
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Allergopharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This trial is performed for the immunological and histological evaluation of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen, rBet v1-FV

Description:

Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against proteins and glycoproteins from plants, insects, animals and fungi, most of which are normally considered harmless. The cross-linking of specific IgE antibodies on effector cells by allergens activates an immunological cascade leading to the symptoms of Type I allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the most common chronic atopic disease and is associated with considerable cost and co-morbidity. Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery, red eyes.

Recombinant preparations offer various advantages over those based on natural allergen extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical quality; proteins are molecularly defined thus ensuring product consistency and minimising problems related to allergen extract standardisation; preparations only include those proteins that are considered relevant for specific immunotherapy; the risk of contamination with other allergenic material is excluded; the whole production process can be designed to exclude any risk factors for the introduction of infectious agents; the relative dosages of individual components of a final preparation can be optimised to favour better clinical efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance beneficial immune responses. The investigational product has demonstrated efficacy and good tolerability in one previous pivotal Phase III and two previous Phase II studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Positive SPT

• Positive EAST

• Positive specific provocation test

Exclusion Criteria:

• Serious chronic diseases

• Other perennial allergies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic

Intervention

Other:
• Placebo
Placebo was given the same way as a subcutaneous (just under the skin) injection.

Biological:
• rBet v1-FV
Placebo was given the same way as a subcutaneous (just under the skin) injection.

Locations

Country	Name	City	State
Sweden	Prof. Dr. med. Sabina Rak	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in populations of inflammatory cells and subpopulations of immunologically active cells.	All these cells were evaluated in nasal biopsies obtained before the start of treatment (outside the birch pollen season) and during immunotherapy (after one year of treatment with rBet v1-FV) around the peak of the pollen season.	Cells were obtained before and after one year of treatment with rBet v1-FV.	No
Secondary	Immunologic changes	Specific IgE, IgG1 and IgG4 were measured at 4 points: at screening visit (V I/1), after uptitration (V II/10) and after birch pollen season in first and second treatment year (V II).	4 time points.	No

External Links

•   Click here for information about this trial in the European Clinical Trials Register
•   Leader in specific allergy research and therapy