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DNA Vaccine for Ragweed Allergic Adults

This study has been withdrawn prior to enrollment.
(The study was halted prior to enrollment pending submission of a IRB amendment which was never completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346086
First Posted: June 29, 2006
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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 Intervention Phase
Seasonal Allergic Rhinitis Drug: AIC (Amb a 1 Immunostimulatory Conjugate) Phase 2

Study Type: Interventional
Study Design: 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)

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Effect of treatment on nasal allergen challenge

Enrollment: 0
Actual Study Start Date: May 18, 2001
Study Completion Date: August 21, 2001
Primary Completion Date: August 21, 2001 (Final data collection date for primary outcome measure)
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346086


Locations
United States, Maryland
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00346086     History of Changes
Other Study ID Numbers: AAC01-03-27-01
NRH01
First Submitted: June 27, 2006
First Posted: June 29, 2006
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
CpG oligonucleotide vaccine
ragweed immunotherapy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases