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
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: 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
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014