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Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
OralvacB2MPL
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Hypersensitivity focused on measuring Allergy, Specific Immunotherapy, Sublingual Immunotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • CRS Clinical Research Services Mannheim GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

4 consecutive groups, dose escalation

4 consecutive groups

Outcomes

Primary Outcome Measures

Adverse Events,

Secondary Outcome Measures

allergic reactions/symptomatology

Full Information

First Posted
October 17, 2005
Last Updated
June 16, 2010
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00241410
Brief Title
Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
Official Title
Investigation of the Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergy Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
Allergy, Specific Immunotherapy, Sublingual Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
4 consecutive groups, dose escalation
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
4 consecutive groups
Intervention Type
Biological
Intervention Name(s)
OralvacB2MPL
Other Intervention Name(s)
MPL and/or grass pollen allergen
Intervention Description
Comparison of different dosages of drug
Primary Outcome Measure Information:
Title
Adverse Events,
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
allergic reactions/symptomatology
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Timmer, MD
Organizational Affiliation
CRS Clinical Research Services Mannheim GmbH, Grenadierstraße 1, 68167 Mannheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRS Clinical Research Services Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany

12. IPD Sharing Statement

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Safety, Immunological Effect and Efficacy of the Combined Application of MPL and Grass Pollen Allergen

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