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

This study has been completed.
Sponsor:
Information provided by:
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT01111279
First received: April 20, 2010
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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

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

Further study details as provided by BioTech Tools S.A.:

Primary Outcome Measures:
  • Clinical tolerability and safety of the treatment [ Time Frame: 3 times during the treatment phase, at week 24 (the end of the study) ] [ Designated as safety issue: Yes ]
    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:
  • Impact of gpASIT+TM on the immunological status of the subjects [ Time Frame: visit 1, week 7, week 18 and week 24 ] [ Designated as safety issue: No ]

    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.

  • Impact of gpASIT+TM on the clinical status of the subjects [ Time Frame: 1 May - 15 August 2010 ] [ Designated as safety issue: No ]

    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 .


Estimated Enrollment: 27
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111279

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

No publications provided

Responsible Party: Thierry Legon / CEO, BioTech Tools
ClinicalTrials.gov Identifier: NCT01111279     History of Changes
Other Study ID Numbers: BTT-gpASIT004
Study First Received: April 20, 2010
Last Updated: February 28, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on April 16, 2014