Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841516
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

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
Allergic Rhinoconjunctivitis 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 Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2013

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 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

Primary Outcome Measures :
  1. 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. ]
    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 [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841516

Prof. Dr. med. Sabina Rak
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Principal Investigator: Sabina Rak, Prof. Dr. med. Rak

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG Identifier: NCT00841516     History of Changes
Other Study ID Numbers: AL0801rB
2008-006258-16 ( EudraCT Number )
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

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

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