DNA Vaccine for Ragweed Allergic Adults
| Status: | Completed |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/15/2018 |
| Start Date: | May 18, 2001 |
| End Date: | August 21, 2001 |
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)
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.
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.
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).
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).
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.
We found this trial at
1
site
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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