DNA Vaccine for Ragweed Allergic Adults

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00346086
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: AIC (Amb a 1 Immunostimulatory Conjugate)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 18, 2001
• Actual Primary Completion Date: Aug 21, 2001
• Actual Study Completion Date: Aug 21, 2001

Outcome Measures

Primary Outcome Measures

1. Effect of treatment on nasal allergen challenge []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00346086
• Other Study ID Numbers: AAC01-03-27-01; NRH01
• First Posted: Jun 29, 2006
• Last Update Posted: Dec 13, 2018
• Last Verified: Dec 1, 2018

• Keywords provided by Johns Hopkins University: CpG oligonucleotide vaccine; ragweed immunotherapy
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Study Results

No Results Posted as of Dec 13, 2018