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Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00841516
First received: February 10, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Allergic Rhinoconjunctivitis
Other: Placebo
Biological: rBet v1-FV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Changes in populations of inflammatory cells and subpopulations of immunologically active cells. [ Time Frame: Cells were obtained before and after one year of treatment with rBet v1-FV. ] [ Designated as safety issue: No ]
    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:
  • Immunologic changes [ Time Frame: 4 time points. ] [ Designated as safety issue: No ]
    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).


Enrollment: 14
Study Start Date: December 2007
Study Completion Date: May 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Specific Immunotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841516

Locations
Sweden
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
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00841516     History of Changes
Other Study ID Numbers: AL0801rB, 2008-006258-16
Study First Received: February 10, 2009
Last Updated: November 7, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Allergopharma GmbH & Co. KG:
Specific immunotherapy
SIT
SCIT
recombinant
Type 1 - Allergy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Conjunctivitis
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014