HypersensitivityPhase 1/2NCT00293904
Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy
A Phase 1/2 study testing CYT005-AllQbG10 in people with Hypersensitivity, run by Cytos Biotechnology AG at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- CYT005-AllQbG10
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2006to Feb 2007
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
- Female participants must meet one of the following criteria:
- No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
- Written informed consent
- Patient is willing and able to comply with all trial requirements
Who cannot join
- Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
- Contraindication to Allergen Preparation
- Contraindication for Nasal Provocation Test
- Contraindication for Skin Prick Test
- Actual significant obstructive pulmonary disorder (FEV1< 70%)
- Pharmacological treatment that could affect allergic sensitivity during the trial
Show all 15Show fewer
- Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
- Serum test positive for HIV, HBV, or HCV
- Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
- Pregnancy or lactation
- Blood donation within 30 days before enrolment
- History of abuse of alcohol or other recreational drugs
- Specific immunotherapy against pollen allergy within the last two years
- Intake of an investigational drug within three month before enrolment
- Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone
- Conditions
- Hypersensitivity
- Being tested
- CYT005-AllQbG10
- Keywords
- Allergy, Grass Pollen, Systemic Immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT005-AllQbG10Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Provocation Tests
Secondary outcomes (1)
Allergy and Medication Questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gabriela Senti, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293904
- Sponsor's protocol ID
- CYT005-AllQbG10 02
- Status last verified
- Sep 2007
- First submitted
- 17 Feb 2006
- Last updated
- 20 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy
- ClinicalTrials.gov ID
- NCT00293904
- Acronym / sponsor ID
- CYT005-AllQbG10 02
- Conditions
- Hypersensitivity
- Keywords
- Allergy, Grass Pollen, Systemic Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 65 years of age
- Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
- Female participants must meet one of the following criteria:
- No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
- Written informed consent
Key exclusion criteria (15 listed)
- Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
- Contraindication to Allergen Preparation
- Contraindication for Nasal Provocation Test
- Contraindication for Skin Prick Test
- Actual significant obstructive pulmonary disorder (FEV1< 70%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT005-AllQbG10 | Biological | – |
Primary outcome
Nasal Provocation Tests
1 secondary outcome
Allergy and Medication Questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Senti, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT005-AllQbG10 in people with Hypersensitivity, run by Cytos Biotechnology AG at 1 site in Switzerland.
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 6 inclusion and 15 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 20 Sep 2007. 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 Switzerland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Nasal Provocation Tests. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2007.