Clinical trial NCT01111279: Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Allergic Rhinoconjunctivitis
Lead sponsor: BioTech Tools S.A.
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical tolerability and safety of the treatment
timeFrame: 3 times during the treatment phase, at week 24 (the end of the study)
Secondary outcomes:
measure: Impact of gpASIT+TM on the immunological status of the subjects
timeFrame: visit 1, week 7, week 18 and week 24
measure: Impact of gpASIT+TM on the clinical status of the subjects
timeFrame: 1 May - 15 August 2010
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven, Gasthuisberg
Study officials:
affiliation: UZ Leuven
name: Jan Ceuppens, Professor
role: PRINCIPAL_INVESTIGATOR
References: