Safety, Clinical Tolerability and Immunogenicity of gpASIT+TM Administered Subcutaneously to Hay Fever Patients Either Alone or in Presence of DnaK Immunoregulating Adjuvant

BioTech Tools S.A.1 site in 1 country24 target enrollmentNovember 2011

ConditionsHay Fever

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hay Fever
Sponsor: BioTech Tools S.A.
Enrollment: 24
Locations: 1
Primary Endpoint: Safety of the treatment
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

April 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BioTech Tools S.A.

Responsible Party

Sponsor

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 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

Outcomes

Primary Outcomes

Safety of the treatment

Time Frame: up to the end of the grass pollen season

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)

The clinical tolerability will by assessed through the solicited local adverse events, all (serious) adverse events and the investigator and subject opinion.

Secondary Outcomes

Impact of gpASIT+TM with or without adjuvant on the immunological status of the subjects.(up to 1 year after the start of treatment)
Impact of gpASIT+TM with or without adjuvant on the grass pollen allergic symptoms of the subjects.(During the pollen season)
Long-term follow-up of the patients(1 year after the start of treatment)