Type I HypersensitivityPhase 2NCT00133146
Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine
A Phase 2 study testing Grass MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Canada.
Trial summary
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2005to 23 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
- Patients had a positive skin prick test for grass and rye allergen (wheal >= 5 mm greater than the negative control)
- Patients had a positive skin prick test to positive histamine control with a wheal (longest) diameter >= 3 mm.
- Patients had a negative skin prick test to negative control; redness, but no wheal was acceptable.
- Specific IgE for grass and rye as documented by radioallergosorbent (RAST) or equivalent test with class >= 2
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE-mediated allergy to pollen from grass and rye
- Patients scored moderate or severe in the disease severity questionnaire
Show all 18Show fewer
- Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Postmenopausal was defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential were required to have a confirmed absence of pregnancy according to a negative urine pregnancy test and were required to be using one of the following acceptable birth control methods:
- Intrauterine device (IUD) in place for at least 90 days
- Barrier method (condom or diaphragm) with spermicide
- Stable hormonal contraceptive for at least 90 days prior to study and through study completion
- Abstinence
- Non-heterosexual lifestyle
- Vasectomised partner for at least 90 days.
- Patients were normally active and otherwise judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests.
- Patients were willing and able to attend required study visits.
- Patients were able to follow instructions.
- Patients were willing and able to give written informed consent and provided this consent. Consent was required prior to the initiation of any washout period.
- Spirometry at Screening demonstrates FEV1>= 80% predicted and FEV1/FVC>= 70%.
Who cannot join
- Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
- Patient has moderate to severe asthma. Patients with mild asthma requiring use of bronchodilators as needed were allowed as long as they did not have significant worsening with seasonal exposure to grass pollen
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
- History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
- Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
- Any clinically significant (as determined by the investigator) abnormal laboratory value at Visit 0
Show all 28Show fewer
- Clinically relevant sensitivity to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium cladosporoides, Alternaria alternata, Penicillium chrysogenum, Aspergillus fumigatus) and epithelia (cat [Felis domesticus], dog [Canis familiaris])
- Patient had clinically relevant sensitivity determined by a positive case history, skin prick test wheal size >= 3 mm in diameter greater than the negative control, or RAST test with class >= 2 against the following summer/autumn season flowering plants: Plantago lanceolata (plantain), Atriplex sp. (orache), Urtica dioica (nettle), Artemisia vulgaris (mugwort), Cynodon dactylon (Bermuda grass), or Ambrosia elatior (ragweed).
- Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis)
- History of autoimmune diseases and/or rheumatoid diseases
- Patients who are taking b-blockers for any indication
- Patients who are not allowed to receive adrenalin
- Disorder of tyrosine metabolism (especially in the case of alcaptonuria, tyrosinemia).
- Presence of a disease with a pathogenesis interfering with the immune response and had received medication which could influence the results of this study
- Documented evidence of acute or significant chronic infection
- History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, or exercise- or drug-induced anaphylaxis.
- Documented history of angioedema
- Hypersensitivity to the excipients in the study medication
- Previous or current hyposensitization therapy with comparable grass allergen extracts
- Currently using anti-allergy medication and other drugs with antihistaminic activity
- Currently participating in a clinical trial or has been exposed to study drug within the last 30 days
- Could not communicate reliably with the Investigator or was not likely to cooperate with the requirements of the study
- Patient is pregnant or planning pregnancy and/or lactating
- Patient has received treatment with preparation containing monophosphoryl lipid A (MPL) during the past 12 months.
- Concurrent use of any prohibited medication or inadequate washout of any medication
- Any systemic disorder that could have interfered with the evaluation of the study drug.
- Clinical history (within 2 years) of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study.
- Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Phase 2a Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Grass/Rye Pollen Allergoid With a Single-Blind Portion to Evaluate Residual Allergenicity in Skin Test in Volunteers Allergic to Grass & Rye Pollen
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).
The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) was investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen.
Additionally, this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.
Read the detailed description
Double-blind Phase IIa study with a single-blind component, to evaluate skin tests allergenicity and to demonstrate the contribution of MPL® to tyrosine adsorbed grass/rye pollen allergoid (Grass MATA) in volunteers allergic to grass and rye pollen. Volunteers underwent skin prick tests with 12 different solutions and then were randomized to receive 3 subcutaneous injections of either Grass MATA MPL or Grass MATA over approximately 14-day intervals for total study duration of approximately 67 days.
Enrollment was planned for 40 patients, 20 in each active treatment group. Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study. Screening was performed at Visit 0, then subjects fulfilling all inclusion/exclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen, modified allergen and tyrosine adsorbates with and without MPL® (Visit 1, single-blind portion of the study).
At Visit 2, subjects were randomized 1:1 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment. The dosing regimen consisted of three 0.5 mL subcutaneous injections of increasing strengths and was the same for both treatment groups. Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated. The second and third injections of treatment were administered at Visit 4 and Visit 6. Each dosing visit occurred at least 14 days after the previous one.
Safety follow-up were performed 7-8 days after each dosing, at Visit 3, 5 and 7.
Subjects terminated the study after completion of Visit 8 (Post-treatment visit).
To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline (Visit 0), after the first administration (Visit 3) and at the end of the study (Visit 8). Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated.
- Conditions
- Type I Hypersensitivity
- Being tested
- Grass MATA MPL
- Keywords
- Allergy, 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
| Study group | Role | What they receive |
|---|---|---|
| Grass MATA MPL | Experimental | 300 SU/0.5 mL Grass MATA MPL (Visit 2);
800 SU/0.5 mL Grass MATA MPL (Visit 4);
2000 SU/0.5 mL Grass MATA MPL (Visit 6) Receives: Biological: Grass MATA MPL |
| Grass MATA | Active comparator | 300 SU/0.5 mL Grass MATA (Visit 2);
800 SU/0.5 mL Grass MATA (Visit 4);
2000 SU/0.5 mL Grass MATA (Visit 6); Receives: Biological: Grass MATA MPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response to GrassMATAMPL versus GrassMATA (grass specific)
Immunoglobulin levels: Timothy Grass specific IgG, Timothy Grass specific IgG1, Timothy Grass specific IgG4, and Timothy Grass specific IgE
Measured: 14 days
Secondary outcomes (18)
Immunological response to Grass MATA MPL versus Grass MATA in volunteers allergic to grass and rye pollen
immunoglobulin levels: rye specific IgG, rye specific IgG1, rye specific IgG4, and rye specific IgE; June grass specific IgG, June Grass specific IgG1, June Grass specific IgG4, and June Grass specific IgE
Measured: up to 10 weeks
Tolerability of native allergen, modified allergen and tyrosine adsorbents with and without MPL® in the skin prick tests
Measured: >= 30 min to 6 hours post application
Tolerability of the cumulative subcutaneous doses compared between Grass MATA MPL and Grass MATA.
The rate of Adverse events reported by subjects in the two groups was compared.
Measured: 6 weeks
Tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups.
The rate of local or systemic Adverse Events occurring within a 24-hour after any injection with study drug in subjects of the two groups was compared.
Measured: Up to 24 hours post-administration
Measure of concentration of Albumin (g/L)
Measured: 10 Weeks
Measure of concentration of Alkaline Phospatase, ALT, AST and LDH (U/L)
Measured: 10 Weeks
Measure of concentration of Bilirubin Total and Creatinine (µmol/L)
Measured: 10 Weeks
Measure of concentration of Calcium, Glucose, Phosphorus, Potassium, Sodium and Urea (mmol/L).
Measured: 10 weeks
Measure of concentration of Red Blood Cells (10E12/L)
Measured: 10 weeks
Measure of concentration of White Blood Cells, Neutrophils, Lymphocytes, Basophils, Eosinophils, Monocytes and Platelets (10E9/L)
Measured: 10 weeks
Measure of concentration of Haemoglobin (g/L)
Measured: 10 weeks
Measure of concentration of Haematocrit (L/L)
Measured: 10 weeks
Vital signs - Blood pressure
Assessment of Sistolic (SBP) and diastolic (DBP) blood pressure.
Measured: 10 weeks
Vital signs - Pulse
Measured: 10 weeks
Vital signs - Temperature
Measured: 10 weeks
12-lead electrocardiogram (ECG)
ECG evaluations by parameter (QRS interval, PR interval, QT interval, and QTc interval) and overall ECG results (normal, abnormal non clinical significant, abnormal clinical significant).
Measured: 10 weeks
Number of adverse events
Measured: Up to 10 weeks
Number of adverse reactions
The total of local or systemic events occurring in one patient within a 24-hour period after any one injection
Measured: Up to 24 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study start12 Sep 2005
- Primary completion23 Nov 2005
- Study completion23 Nov 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Jürgen Fischer von Weikersthal-Drachenberg, MD, Study chair, Allergy Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133146
- Sponsor's protocol ID
- GrassMATAMPL202
- Other IDs
- P2DP05004
- Status last verified
- Jul 2021
- First submitted
- 22 Aug 2005
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Phase 2a Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Grass/Rye Pollen Allergoid With a Single-Blind Portion to Evaluate Residual Allergenicity in Skin Test in Volunteers Allergic to Grass & Rye Pollen
- ClinicalTrials.gov ID
- NCT00133146
- Acronym / sponsor ID
- GrassMATAMPL202
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Specific Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2005 (actual)
- Primary completion
- 23 Nov 2005 (actual)
- Study completion
- 23 Nov 2005 (actual)
- First posted
- 23 Aug 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.
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).
The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) was investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen.
Additionally, this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.
Detailed description
Double-blind Phase IIa study with a single-blind component, to evaluate skin tests allergenicity and to demonstrate the contribution of MPL® to tyrosine adsorbed grass/rye pollen allergoid (Grass MATA) in volunteers allergic to grass and rye pollen. Volunteers underwent skin prick tests with 12 different solutions and then were randomized to receive 3 subcutaneous injections of either Grass MATA MPL or Grass MATA over approximately 14-day intervals for total study duration of approximately 67 days.
Enrollment was planned for 40 patients, 20 in each active treatment group. Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study. Screening was performed at Visit 0, then subjects fulfilling all inclusion/exclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen, modified allergen and tyrosine adsorbates with and without MPL® (Visit 1, single-blind portion of the study).
At Visit 2, subjects were randomized 1:1 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment. The dosing regimen consisted of three 0.5 mL subcutaneous injections of increasing strengths and was the same for both treatment groups. Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated. The second and third injections of treatment were administered at Visit 4 and Visit 6. Each dosing visit occurred at least 14 days after the previous one.
Safety follow-up were performed 7-8 days after each dosing, at Visit 3, 5 and 7.
Subjects terminated the study after completion of Visit 8 (Post-treatment visit).
To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline (Visit 0), after the first administration (Visit 3) and at the end of the study (Visit 8). Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grass MATA MPL | Experimental | Biological: Grass MATA MPL300 SU/0.5 mL Grass MATA MPL (Visit 2); 800 SU/0.5 mL Grass MATA MPL (Visit 4); 2000 SU/0.5 mL Grass MATA MPL (Visit 6) |
| Grass MATA | Active comparator | Biological: Grass MATA MPL300 SU/0.5 mL Grass MATA (Visit 2); 800 SU/0.5 mL Grass MATA (Visit 4); 2000 SU/0.5 mL Grass MATA (Visit 6); |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Patients had a positive skin prick test for grass and rye allergen (wheal >= 5 mm greater than the negative control)
- Patients had a positive skin prick test to positive histamine control with a wheal (longest) diameter >= 3 mm.
- Patients had a negative skin prick test to negative control; redness, but no wheal was acceptable.
- Specific IgE for grass and rye as documented by radioallergosorbent (RAST) or equivalent test with class >= 2
- History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE-mediated allergy to pollen from grass and rye
Key exclusion criteria (28 listed)
- Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
- Patient has moderate to severe asthma. Patients with mild asthma requiring use of bronchodilators as needed were allowed as long as they did not have significant worsening with seasonal exposure to grass pollen
- Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
- History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
- Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
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 | Grass MATA, Grass MATA MPL |
Primary outcome
Immunological response to GrassMATAMPL versus GrassMATA (grass specific)
Time frame: 14 days
Immunoglobulin levels: Timothy Grass specific IgG, Timothy Grass specific IgG1, Timothy Grass specific IgG4, and Timothy Grass specific IgE
18 secondary outcomes
Immunological response to Grass MATA MPL versus Grass MATA in volunteers allergic to grass and rye pollen
Time frame: up to 10 weeks
Tolerability of native allergen, modified allergen and tyrosine adsorbents with and without MPL® in the skin prick tests
Time frame: >= 30 min to 6 hours post application
Tolerability of the cumulative subcutaneous doses compared between Grass MATA MPL and Grass MATA.
Time frame: 6 weeks
Tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups.
Time frame: Up to 24 hours post-administration
Measure of concentration of Albumin (g/L)
Time frame: 10 Weeks
Measure of concentration of Alkaline Phospatase, ALT, AST and LDH (U/L)
Time frame: 10 Weeks
Measure of concentration of Bilirubin Total and Creatinine (µmol/L)
Time frame: 10 Weeks
Measure of concentration of Calcium, Glucose, Phosphorus, Potassium, Sodium and Urea (mmol/L).
Time frame: 10 weeks
Measure of concentration of Red Blood Cells (10E12/L)
Time frame: 10 weeks
Measure of concentration of White Blood Cells, Neutrophils, Lymphocytes, Basophils, Eosinophils, Monocytes and Platelets (10E9/L)
Time frame: 10 weeks
Measure of concentration of Haemoglobin (g/L)
Time frame: 10 weeks
Measure of concentration of Haematocrit (L/L)
Time frame: 10 weeks
Vital signs - Blood pressure
Time frame: 10 weeks
Vital signs - Pulse
Time frame: 10 weeks
Vital signs - Temperature
Time frame: 10 weeks
12-lead electrocardiogram (ECG)
Time frame: 10 weeks
Number of adverse events
Time frame: Up to 10 weeks
Number of adverse reactions
Time frame: Up to 24 hours post-injection
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 13 Jul 2021.
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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.
Karl Jürgen Fischer von Weikersthal-Drachenberg, MD study chair
Allergy Therapeutics
1 site 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 1 site in Canada.
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 18 inclusion and 28 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 13 Jul 2021. 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 Canada. 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?
Immunological response to GrassMATAMPL versus GrassMATA (grass specific) (time frame: 14 days). 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 13 Jul 2021.