DNA Vaccine for Ragweed Allergic Adults

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00346086
First received: June 27, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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

Secondary Outcome Measures:
  • Clinical endpoints
  • Antibody measurements
  • T-cell and cytokine assays

Estimated Enrollment: 36
Study Start Date: May 2001
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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 postiive 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00346086     History of Changes
Other Study ID Numbers: AAC01-03-27-01, NRH01
Study First Received: June 27, 2006
Last Updated: June 27, 2006
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014