Back to resultsDNA Vaccine for Ragweed Allergic Adults
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AIC (Amb a 1 Immunostimulatory Conjugate)
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring CpG oligonucleotide vaccine, ragweed immunotherapy
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.
Sites / Locations
- Johns Hopkins University School of Medicine
Outcomes
Primary Outcome Measures
Effect of treatment on nasal allergen challenge
Secondary Outcome Measures
Full Information
NCT ID
NCT00346086
First Posted
June 27, 2006
Last Updated
December 12, 2018
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00346086
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2001 (Actual)
Primary Completion Date
August 21, 2001 (Actual)
Study Completion Date
August 21, 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
CpG oligonucleotide vaccine, ragweed immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AIC (Amb a 1 Immunostimulatory Conjugate)
Primary Outcome Measure Information:
Title
Effect of treatment on nasal allergen challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Creticos, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17021320
Citation
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. doi: 10.1056/NEJMoa052916.
Results Reference
derived
Learn more about this trial
DNA Vaccine for Ragweed Allergic Adults
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