DNA Vaccine for Ragweed Allergic Adults

• ClinicalTrials.gov Identifier: NCT00346086
• Recruitment Status: Completed
• First Posted: June 29, 2006
• Last Update Posted: December 13, 2018
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: June 27, 2006
• First Posted Date: June 29, 2006
• Last Update Posted Date: December 13, 2018
• Actual Study Start Date: May 18, 2001
• Actual Primary Completion Date: August 21, 2001 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 27, 2006): Effect of treatment on nasal allergen challenge
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: June 27, 2006)

• Clinical endpoints
• Antibody measurements
• T-cell and cytokine assays

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DNA Vaccine for Ragweed Allergic Adults
• 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)
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Seasonal Allergic Rhinitis
• Intervention: Drug: AIC (Amb a 1 Immunostimulatory Conjugate)
• Study Arms: Not Provided
• Publications *: Creticos PS, Schroeder JT, Hamilton RG, Balcer-Whaley SL, Khattignavong AP, Lindblad R, Li H, Coffman R, Seyfert V, Eiden JJ, Broide D; Immune Tolerance Network Group. Immunotherapy with a ragweed-toll-like receptor 9 agonist vaccine for allergic rhinitis. N Engl J Med. 2006 Oct 5;355(14):1445-55.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2018): 25
• Original Enrollment (submitted: June 27, 2006): 36
• Actual Study Completion Date: August 21, 2001
• Actual Primary Completion Date: August 21, 2001 (Final data collection date for primary outcome measure)

Eligibility 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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00346086
• Other Study ID Numbers: AAC01-03-27-01; NRH01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter S Creticos, M.D.; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: December 2018