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Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

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: NCT01111279
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : March 1, 2011
Information provided by:
BioTech Tools S.A.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinoconjunctivitis Biological: gpASIT+TM Biological: gpAST+TM/adjuvant Biological: Placebo solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Placebo Comparator: Placebo Biological: Placebo solution
1 subcutaneous injection every 7 days, during 29 days

Experimental: gpASIT+TM Biological: gpASIT+TM
1 subcutaneous injection every 7 days, during 29 days.

Experimental: gpASIT+TM/adjuvant Biological: gpAST+TM/adjuvant
1 subcutaneous injection every 7 days, during 29 days

Primary Outcome Measures :
  1. Clinical tolerability and safety of the treatment [ Time Frame: 3 times during the treatment phase, at week 24 (the end of the study) ]
    The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate)

Secondary Outcome Measures :
  1. Impact of gpASIT+TM on the immunological status of the subjects [ Time Frame: visit 1, week 7, week 18 and week 24 ]

    The following parameters will be assessed :

    • allergen-specific IgE, IgG, IgG4, IgA antibody concentrations,
    • adjuvant-specific IgG antibody concentrations,
    • lymphoproliferation and production of IL-10 in allergen and adjuvant stimulated PBMC.

  2. Impact of gpASIT+TM on the clinical status of the subjects [ Time Frame: 1 May - 15 August 2010 ]

    The following parameters will be assessed (during the pollen season following treatment):

    • daily average allergic symptom score,
    • daily average allergic medication score,
    • number of "well-days",
    • Visual Analogue Scale .

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has given written informed consent
  • Age between 18 and 50 years
  • The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
  • Male or non pregnant, non-lactating female
  • Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
  • Allergy diagnosis:

    • A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during the two previous years
    • A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
    • Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l)
    • Asymptomatic to perennial inhalant allergens even if shown to be hypersensitive in a skin prick test.

Exclusion Criteria:

  • Subjects with current or past immunotherapy (any time in the past)
  • A history of hypersensitivity to the excipients
  • Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
  • Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
  • Subjects with a history of hepatic or renal disease
  • Subjects symptomatic to perennial inhalant allergens
  • Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
  • Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease)
  • Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
  • Subjects requiring beta-blockers medication
  • Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
  • Subject with febrile illness (> 37.5°C, oral)
  • A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
  • The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
  • Receipt of blood or a blood derivative in the past 6 months preceding trial entry
  • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
  • Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
  • Use of long-acting antihistamines
  • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
  • Any condition which could be incompatible with protocol understanding and compliance
  • Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
  • Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
  • Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
  • Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
  • Subjects who participated to trial BTT-gpASIT003 and were in the treated groups

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): NCT01111279

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UZ Leuven, Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
BioTech Tools S.A.
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Principal Investigator: Jan Ceuppens, Professor UZ Leuven

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Responsible Party: Thierry Legon / CEO, BioTech Tools Identifier: NCT01111279    
Other Study ID Numbers: BTT-gpASIT004
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Conjunctival Diseases
Eye Diseases