Type I HypersensitivityPhase 2NCT00104377
Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
A Phase 2 study testing Grass MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 11 sites in United States.
Trial summary
Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye pollen. Different doses of Grass MATA will be administered and immunological changes following this treatment will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type I Hypersensitivity
- What is being tested?
- Grass MATA MPL
- How many people
- 70 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2005to Nov 2005
- 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
- Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis without bronchial asthma due to an IgE mediated allergy to pollen from grasses and rye
- Positive skin prick test to grass pollen and to rye pollen allergen extract
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control
- Specific IgE for grass and rye as documented by a RAST or equivalent test
- Moderate/severe allergy symptoms in the past spring season
- Spirometry at Screening demonstrates FEV1 >= 80% predicted and FEV1/FVC >= 70%.
Who cannot join
- History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the screening skin prick tests; both forearms must be available for testing
- History of bronchial asthma, chronic obstructive pulmonary disease (COPD), or other chronic condition of the lower respiratory tract
- History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
- Any clinically significant abnormal laboratory value at Visit 1
- Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, or epithelia (cat, dog, and horse). Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to perennial allergens.
Show all 23Show fewer
- Clinically relevant sensitivity to any common springtime flowering plant: Birch, Oak, Sycamore, Beech, Ash and Poplar. Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to these springtime allergens.
- History of auto-immune diseases or rheumatoid diseases
- Subject not allowed to receive adrenalin
- Subject has disorder of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia)
- Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
- Subject has acute or chronic infection
- History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
- History of angioedema
- History of hypersensitivity to the excipients of the study medication
- History of immunotherapy with grass allergen extracts
- Current therapy with ß-blockers
- Currently receiving anti-allergy medication or other medications with an antihistaminic activity
- Subject has a positive drugs of abuse screen at Visit 1
- Subject participated in a clinical trial with an investigational medication within the last 3 months
- Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
- Subject is pregnant or lactating
- Use of prohibited medications or inadequate washout periods prior to screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Allergy, Asthma, and Immunology Assoc. PC
Lincoln, Nebraska, 68505
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
College Park Family Care Center Multi-Specialty Clinical Research
Overland Park, Kansas, 66210
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Allergy Associates Research Center
Portland, Oregon, 97213
Sylvana Research Associates
San Antonio, Texas, 78229
Midwest Clinical research, LLC
St Louis, Missouri, 63141
Asthma, Sinus, and Allergy Centers, LLC
Tinton Falls, New Jersey, 07701
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
About this study
Official title: A Multicenter, Single-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye pollen. Different doses of Grass MATA will be administered and immunological changes following this treatment will be assessed.
Read the detailed description
Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens.
The grass pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities, is not seen.
MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like T cell profile.
The purpose of this study is to assess specific immunological changes (IgG, IgG1, IgG4 and IgE) in allergic subjects following 2 subcutaneous injections of different doses of study medication (Grass MATA or placebo) administered 3 weeks apart. The immunological changes will be used to assess the performance of the R7 IgG reactivity assay over a range of clinically efficacious doses.
- Conditions
- Type I Hypersensitivity
- Being tested
- Grass MATA MPL
- Keywords
- Allergy, Allergoid, Specific Immunotherapy
- Medical subject headings
- Hypersensitivity, Immediate, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass MATA MPLBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess specific immunological changes (IgG, IgG1, IgG4, IgE) in grass and rye allergic subjects following 2 subcutaneous injections of study medication (different doses of Grass MATA or placebo) administered 3 weeks apart.
Secondary outcomes (3)
adverse events
clinical laboratory evaluations
vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2005 (estimated)
- Study startMar 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul H. Ratner, MD, Principal investigator, Sylvana Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104377
- Sponsor's protocol ID
- GrassMATAMPL201
- Status last verified
- Sep 2009
- First submitted
- 28 Feb 2005
- Last updated
- 17 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
- ClinicalTrials.gov ID
- NCT00104377
- Acronym / sponsor ID
- GrassMATAMPL201
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Allergoid, Specific Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2005
- First posted
- 1 Mar 2005 (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.
Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye pollen. Different doses of Grass MATA will be administered and immunological changes following this treatment will be assessed.
Detailed description
Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens.
The grass pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities, is not seen.
MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like T cell profile.
The purpose of this study is to assess specific immunological changes (IgG, IgG1, IgG4 and IgE) in allergic subjects following 2 subcutaneous injections of different doses of study medication (Grass MATA or placebo) administered 3 weeks apart. The immunological changes will be used to assess the performance of the R7 IgG reactivity assay over a range of clinically efficacious doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis without bronchial asthma due to an IgE mediated allergy to pollen from grasses and rye
- Positive skin prick test to grass pollen and to rye pollen allergen extract
- Positive skin prick test to positive histamine control
- Negative skin prick test to negative control
Key exclusion criteria (23 listed)
- History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the screening skin prick tests; both forearms must be available for testing
- History of bronchial asthma, chronic obstructive pulmonary disease (COPD), or other chronic condition of the lower respiratory tract
- History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
- Any clinically significant abnormal laboratory value at Visit 1
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 |
|---|---|---|
| Grass MATA MPL | Biological | – |
Primary outcome
To assess specific immunological changes (IgG, IgG1, IgG4, IgE) in grass and rye allergic subjects following 2 subcutaneous injections of study medication (different doses of Grass MATA or placebo) administered 3 weeks apart.
3 secondary outcomes
adverse events
clinical laboratory evaluations
vital signs
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 17 Jun 2010.
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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.
Paul H. Ratner, MD principal investigator
Sylvana Research Associates
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Grass MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 11 sites in United States.
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 8 inclusion and 23 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 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
To assess specific immunological changes (IgG, IgG1, IgG4, IgE) in grass and rye allergic subjects following 2 subcutaneous injections of study medication (different doses of Grass MATA or placebo) administered 3 weeks apart.. 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 17 Jun 2010.