DNA Vaccine for Ragweed Allergic Adults
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)
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2001
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2001
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedDecember 13, 2018
December 1, 2018
3 months
June 27, 2006
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of treatment on nasal allergen challenge
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
Related Publications (1)
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.
PMID: 17021320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter S Creticos, M.D.
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 29, 2006
Study Start
May 18, 2001
Primary Completion
August 21, 2001
Study Completion
August 21, 2001
Last Updated
December 13, 2018
Record last verified: 2018-12