DNA Vaccine for Ragweed Allergic Adults - Tabular View

Tracking Information

First Received Date ^ICMJE

June 27, 2006

Last Updated Date

June 27, 2006

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Effect of treatment on nasal allergen challenge

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Clinical endpoints
Antibody measurements
T-cell and cytokine assays

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

DNA Vaccine for Ragweed Allergic Adults

Official Title ^ICMJE

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)

Brief Summary

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.

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).

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Drug: AIC (Amb a 1 Immunostimulatory Conjugate)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00346086

Responsible Party

Study ID Numbers ^ICMJE

AAC01-03-27-01, NRH01

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter S Creticos, M.D.

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP