Type I HypersensitivityPhase 1NCT00241410
Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
A Phase 1 study testing OralvacB2MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Germany.
Trial summary
Safety and tolerability of different dose combinations of MPL and grass pollen allergen and to identify the highest combinations of MPL and grass pollen allergen which is safe. Pharmacodynamics and efficacy of MPL and grass pollen allergen. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type I Hypersensitivity
- What is being tested?
- OralvacB2MPL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Jan 2007
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, between 18 and 65 years.
- BMI 18 - 32 kg/m².
- Positive skin prick test (wheal>4mm) with grasses pollen allergen extract.
- Specific IgE to grass pollen allergens by RAST (or equivalent test) ≥ class 2.
- Women of childbearing potential must be using a medically acceptable method of birth control and have a negative β-HCG pregnancy test result at screening and Day 1 predose. Male subjects must also agree to use the double barrier method of contraception during the study.
- In the opinion of the investigator, each subject will be able to understand verbal and written instructions and competent to follow these instructions.
- Subjects must read, understand, sign, and date the written informed consent form
Who cannot join
- Positive human immunodeficiency virus (HIV)-test, acute or chronic hepatitis B/C (except vaccination titer).
- Positive drug screen.
- Positive alcohol breath test.
- Known or suspected drug or alcohol abuse.
- History of clinically significant cardiovascular (especially heart failure or pulmonary insufficiency), pulmonary (except for asthma), hepatic, renal, gastrointestinal, hematologic, endocrine, dermatological, or metabolic disease within the last 2 years. A clinically significant disease is defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's eligibility to participate in the trial.
- Clinically significant abnormalities on pre-study physical examination, vital signs, electrocardiogram (ECG), or laboratory tests; acute illness within 7 days before the screening visit.
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- History of allergy to all-season allergens and / or history of allergy to other seasonal allergens than grass pollen which might interfere with period of trial conduct
- History of a major psychiatric disorder such as schizophrenia, other psychotic symptomatology, major depressive disorder, or suicide attempt within the past 5 years; history of alcohol or drug abuse within the past year; history or evidence of a progressive central nervous system (CNS) disease, lesion, or encephalopathy.
- History of malignancy within the past 2 years; with the exception of basal cell carcinoma.
- Acute or subacute atopic dermatitis.
- Periodontitis, gingivitis, gingival bleeding or other mucosal disorders in the oral cavity or planned tooth extraction during the course of the study.
- Secondary changes of the reactive organs (e.g., emphysema, bronchiectasis).
- Auto-immune disease (e.g., of liver, kidney, thyroid, nervous system) rheumatoid diseases.
- Immunodeficiencies (e.g., by immunosuppressive agents).
- Therapy with β-blockers.
- Therapy with antihistamines less than three days prior to Day 1 .
- Therapy with corticosteroids (except hormonal contraceptives) four weeks prior to Day 1 (with the exception of local steroids, which must be terminated from three days prior to Day 1).
- Vaccinations in the last three months.
- Unable to comply with recommended therapy-free interval for specified medications prior to skin prick test.
- Current diseases with a pathogenesis interfering with the immune response and diseases for which medication has been given, which could influence the results of this study.
- Acute or chronic infection.
- Already undergone hyposensitization therapy with grass pollen allergens within the last three years.
- Use of MPL-containing products within the last 12 months or allergy / hypersensitivity to MPL.
- Pregnancy or breast-feeding.
- Use of any investigational drug or medical device within 30 days prior to the screening visit.
- A handicap that would prevent compliance with the study procedures or proper reporting of adverse events.
- Subjects who smoke more than 10 cigarettes a day
- Subjects unable to conduct nasal washes and comply with nasal challenge tests according to the instruction of the investigator
- Total flow during rhinomanometry with vehicle solution is more than 40% lower than total flow obtained with blank measurement (note: this exclusion criteria does not apply to the screening visit but to nasal challenge test performed on Day 1 predose)
- In the opinion of the investigator, unable to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
Safety and tolerability of different dose combinations of MPL and grass pollen allergen and to identify the highest combinations of MPL and grass pollen allergen which is safe.
Pharmacodynamics and efficacy of MPL and grass pollen allergen.
Read the detailed description
Objective of this trial is to demonstrate the safety and tolerability of different dose combinations of MPL and grass pollen allergen and to identify the highest combination of MPL and grass pollen allergen which is safe.
Other objectives are to investigate the pharmacodynamics and efficacy of MPL and grass pollen allergen.
- Conditions
- Type I Hypersensitivity
- Being tested
- OralvacB2MPL
- Keywords
- Allergy, Specific Immunotherapy, Sublingual 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.
OralvacB2MPLBiological
Also called MPL and/or grass pollen allergen
Comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4 consecutive groups, dose escalation Receives: Biological: OralvacB2MPL |
| 2 | Placebo comparator | 4 consecutive groups Receives: Biological: OralvacB2MPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events,
Measured: 18 weeks
Secondary outcomes (1)
allergic reactions/symptomatology
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2007
- Study completionJan 2007
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Timmer, MD, Principal investigator, CRS Clinical Research Services Mannheim GmbH, Grenadierstraße 1, 68167 Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241410
- Sponsor's protocol ID
- OralvacB2MPL103
- Other IDs
- EudraCT No.: 2005-004095-20
- Status last verified
- Sep 2009
- First submitted
- 17 Oct 2005
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- 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
- Investigation of the Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
- ClinicalTrials.gov ID
- NCT00241410
- Acronym / sponsor ID
- OralvacB2MPL103
- Conditions
- Type I Hypersensitivity
- Keywords
- Allergy, Specific Immunotherapy, Sublingual Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Oct 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.
Safety and tolerability of different dose combinations of MPL and grass pollen allergen and to identify the highest combinations of MPL and grass pollen allergen which is safe.
Pharmacodynamics and efficacy of MPL and grass pollen allergen.
Detailed description
Objective of this trial is to demonstrate the safety and tolerability of different dose combinations of MPL and grass pollen allergen and to identify the highest combination of MPL and grass pollen allergen which is safe.
Other objectives are to investigate the pharmacodynamics and efficacy of MPL and grass pollen allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: OralvacB2MPL4 consecutive groups, dose escalation |
| 2 | Placebo comparator | Biological: OralvacB2MPL4 consecutive groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, between 18 and 65 years.
- BMI 18 - 32 kg/m².
- Positive skin prick test (wheal>4mm) with grasses pollen allergen extract.
- Specific IgE to grass pollen allergens by RAST (or equivalent test) ≥ class 2.
- Women of childbearing potential must be using a medically acceptable method of birth control and have a negative β-HCG pregnancy test result at screening and Day 1 predose. Male subjects must also agree to use the double barrier method of contraception during the study.
Key exclusion criteria (30 listed)
- Positive human immunodeficiency virus (HIV)-test, acute or chronic hepatitis B/C (except vaccination titer).
- Positive drug screen.
- Positive alcohol breath test.
- Known or suspected drug or alcohol abuse.
- History of clinically significant cardiovascular (especially heart failure or pulmonary insufficiency), pulmonary (except for asthma), hepatic, renal, gastrointestinal, hematologic, endocrine, dermatological, or metabolic disease within the last 2 years. A clinically significant disease is defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's eligibility to participate in the trial.
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 |
|---|---|---|
| OralvacB2MPLAlso: MPL and/or grass pollen allergenComparison of different dosages of drug | Biological | 1, 2 |
Primary outcome
Adverse Events,
Time frame: 18 weeks
1 secondary outcome
allergic reactions/symptomatology
Time frame: 18 weeks
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.
Wolfgang Timmer, MD principal investigator
CRS Clinical Research Services Mannheim GmbH, Grenadierstraße 1, 68167 Mannheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OralvacB2MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 1 site in Germany.
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 7 inclusion and 30 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 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 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.
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?
Adverse Events, (time frame: 18 weeks). 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.