DNA Vaccine for Ragweed Allergic Adults

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis

• Registration Number: NCT00346086
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2001-05-18
• Primary Completion: 2001-08-21
• Study Completion: 2001-08-21
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 positive 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of treatment on nasal allergen challenge

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States