Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT01506375
First received: December 7, 2011
Last updated: May 23, 2014
Last verified: August 2012
  Purpose

The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).


Condition Intervention Phase
Hay Fever
Biological: gpASIT+TM
Biological: gpASIT+TM + adjuvant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Clinical Tolerability and Immunogenicity of gpASIT+TM Administered Subcutaneously to Hay Fever Patients Either Alone or in Presence of DnaK Immunoregulating Adjuvant

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety of the treatment [ Time Frame: up to the end of the grass pollen season ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the following parameters: general physical status, vital signs, haematological parameters, general biochemical parameters, solicited local adverse events, all (serious) adverse events, immunological analysis (total IgG and IgE), inflammatory parameters (CRP) and anti-adjuvant mmunoglobulins.

  • Clinical tolerability of the treatment [ Time Frame: Duration of treatment period (4 weeks) ] [ Designated as safety issue: Yes ]
    The clinical tolerability will by assessed through the solicited local adverse events, all (serious) adverse events and the investigator and subject opinion.


Secondary Outcome Measures:
  • Impact of gpASIT+TM with or without adjuvant on the immunological status of the subjects. [ Time Frame: up to 1 year after the start of treatment ] [ Designated as safety issue: No ]
    The following parameters will be assessed: allergen-specific immunoglobulins and blocking antibodies.

  • Impact of gpASIT+TM with or without adjuvant on the grass pollen allergic symptoms of the subjects. [ Time Frame: During the pollen season ] [ Designated as safety issue: No ]
    The following parameters will be recorded: symptom and rescue medication scores (diary cards), Quality-of-Life (RQLQ(S)).

  • Long-term follow-up of the patients [ Time Frame: 1 year after the start of treatment ] [ Designated as safety issue: Yes ]

    Safety parameters will be: immunological analysis (Total IgG and IgE), inflammatory parameters (CRP), DnaK-specific immunoglobulins and SAEs.

    Immunogenicity parameters will be: evolution of grass pollen specific immunoglobulins and of blocking antibodies.



Enrollment: 24
Study Start Date: November 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gpASIT
grass pollen peptides alone
Biological: gpASIT+TM
1 subcutaneous injection every 7 days during 29 days
Experimental: gpASIT/adjuvant
grass pollen peptides + adjuvant
Biological: gpASIT+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 medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
    • A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
    • Specific IgE against grass pollen (IgE > 0.7 kU/l) [using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)]
  • Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011)

Exclusion Criteria:

  • Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
  • Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
  • A history of hypersensitivity to the excipients of investigational products
  • Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
  • Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
  • Subjects with a VC < 80% and a FEV1 < 70% of predicted value at the screening visit
  • Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period
  • Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
  • Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
  • Subjects with a history of renal disease or chronic hepatic disease
  • Subject with malignant disease, autoimmune disease
  • Any chronic disease, which may impair the subject's ability to participate in the trial
  • 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)
  • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial (screening visit)
  • Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial (screening visit)
  • Subject with febrile illness (> 37.5°C, oral)
  • A known positive serology for HIV-1/2, HBV or HCV
  • Subjects that are immunocompromised by medication or illness, have 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
  • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
  • 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
  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: NCT01506375

Locations
Belgium
Universitaire Ziekenhuis van Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
BioTech Tools S.A.
  More Information

No publications provided

Responsible Party: BioTech Tools S.A.
ClinicalTrials.gov Identifier: NCT01506375     History of Changes
Other Study ID Numbers: gpASIT006, 2011-004486-33
Study First Received: December 7, 2011
Last Updated: May 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by BioTech Tools S.A.:
seasonal allergic rhinoconjunctivitis
grass pollen
allergen specific immunotherapy

Additional relevant MeSH terms:
Fever
Rhinitis, Allergic, Seasonal
Body Temperature Changes
Signs and Symptoms
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014