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Hay FeverPhase 2NCT01506375

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

A Phase 2 study testing gpASIT+TM and gpASIT+TM + adjuvant in people with Hay Fever, run by BioTech Tools S.A. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Hay Fever
What is being tested?
gpASIT+TM and gpASIT+TM + adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBelgium
Study dates
Nov 2011to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universitaire Ziekenhuis van Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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).

Conditions
Hay Fever
Being tested
gpASIT+TM, gpASIT+TM + adjuvant
Keywords
seasonal allergic rhinoconjunctivitis, grass pollen, allergen specific immunotherapy
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gpASIT+TMBiological

    1 subcutaneous injection every 7 days during 29 days

  • gpASIT+TM + adjuvantBiological

    1 subcutaneous injection every 7 days during 29 days

Study groups in NCT01506375
Study groupRoleWhat they receive
gpASITExperimentalgrass pollen peptides alone
Receives: Biological: gpASIT+TM
gpASIT/adjuvantExperimentalgrass pollen peptides + adjuvant
Receives: Biological: gpASIT+TM + adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of the treatment

    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.

    Measured: up to the end of the grass pollen season

  2. Clinical tolerability of the treatment

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

    Measured: Duration of treatment period (4 weeks)

Secondary outcomes (3)

  1. Impact of gpASIT+TM with or without adjuvant on the immunological status of the subjects.

    The following parameters will be assessed: allergen-specific immunoglobulins and blocking antibodies.

    Measured: up to 1 year after the start of treatment

  2. Impact of gpASIT+TM with or without adjuvant on the grass pollen allergic symptoms of the subjects.

    The following parameters will be recorded: symptom and rescue medication scores (diary cards), Quality-of-Life (RQLQ(S)).

    Measured: During the pollen season

  3. Long-term follow-up of the patients

    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.

    Measured: 1 year after the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506375
Sponsor's protocol ID
gpASIT006
Other IDs
2011-004486-33
Status last verified
Aug 2012
First submitted
7 Dec 2011
Last updated
26 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gpASIT+TM and gpASIT+TM + adjuvant in people with Hay Fever, run by BioTech Tools S.A. at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the treatment (time frame: up to the end of the grass pollen season). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.

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