DNA Vaccine for Ragweed Allergic Adults - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00346086

Purpose

Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: AIC (Amb a 1 Immunostimulatory Conjugate)	Phase II

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Observer-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety, Tolerability, and Immunogenicity of Subcutaneously Administered Dynavax Amb a 1 Immunostimulatory Oligodeoxyribonucleotide Conjugate (AIC) in Ragweed-Allergic Adults (Sponsor's Protocol NRH01)

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Effect of treatment on nasal allergen challenge

Secondary Outcome Measures:

Clinical endpoints
Antibody measurements
T-cell and cytokine assays

Estimated Enrollment:	36
Study Start Date:	May 2001

Detailed Description:

Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell assays, cytokine assays, nasal provocation).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Adult men and women 18 to 60 years of age;
Who provide informed consent;
Have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy;
Exhibit a postiive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge;
Are in general good health; and are available for the duration of the study.

Exclusion Criteria:

Individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded.
Those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346086

Locations

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Peter S Creticos, M.D.

Johns Hopkins University

More Information

Study ID Numbers:	AAC01-03-27-01, NRH01
Study First Received:	June 27, 2006
Last Updated:	June 27, 2006
ClinicalTrials.gov Identifier:	NCT00346086
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

CpG oligonucleotide vaccine
ragweed immunotherapy

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Rhinitis
CPG-oligonucleotide
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009