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

NCT00241410 | Completed Phase 1

• 2 other identifiers: OralvacB2MPL103EudraCT No.: 2005-004095-20
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy; Sublingual Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Adverse Events,

  18 weeks

Secondary Outcomes (1)

• allergic reactions/symptomatology

  18 weeks

Study Arms (2)

1

EXPERIMENTAL

4 consecutive groups, dose escalation

Biological: OralvacB2MPL

2

PLACEBO COMPARATOR

4 consecutive groups

Biological: OralvacB2MPL

Interventions

OralvacB2MPL BIOLOGICAL

Comparison of different dosages of drug

Also known as: MPL and/or grass pollen allergen

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Wolfgang Timmer, MD

  CRS Clinical Research Services Mannheim GmbH, Grenadierstraße 1, 68167 Mannheim, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: December 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: June 17, 2010

Record last verified: 2009-09

Locations

DE (1)