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Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative

Sponsor
Allergopharma GmbH & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT00841516
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
65
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Placebo
  • Biological: rBet v1-FV
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

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

    		•
    Experimental: 80 µg rBet v1-FV Immunotherapy

    All randomized patients were treated with either placebo or 80 µg rBet v1-FV (maintenance dose) for 2 years.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in populations of inflammatory cells and subpopulations of immunologically active cells. [Cells were obtained before and after one year of treatment with rBet v1-FV.]

      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.

    Secondary Outcome Measures

    1. Immunologic changes [4 time points.]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Positive SPT

    • Positive EAST

    • Positive specific provocation test

    Exclusion Criteria:

    • Serious chronic diseases

    • Other perennial allergies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof. Dr. med. Sabina Rak Gothenburg Sweden 41345

    Sponsors and Collaborators

    • Allergopharma GmbH & Co. KG

    Investigators

    • Principal Investigator: Sabina Rak, Prof.Dr.med., Prof. Dr. med. Rak

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergopharma GmbH & Co. KG
    ClinicalTrials.gov Identifier:
    NCT00841516
    Other Study ID Numbers:
    • AL0801rB
    • 2008-006258-16
    First Posted:
    Feb 11, 2009
    Last Update Posted:
    Nov 8, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Allergopharma GmbH & Co. KG
    Specific immunotherapy
    SIT
    SCIT
    recombinant
    Type 1 - Allergy

    Study Results

    No Results Posted as of Nov 8, 2013