drugset / Trial / NCT00346086

DNA Vaccine for Ragweed Allergic Adults

NCT00346086 ↗

Phase 2 Completed 25 enrolled Johns Hopkins University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-05-18
Primary completion
2001-08-21
Completion
2001-08-21

Outcome

Missed primary endpoint

paper AIC did not alter the primary end point, the vascular permeability response (measured by the albumin level in nasal-lavage fluid) to nasal provocation. PMID 17021320 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amb a 1 Immunostimulatory Conjugate Vaccine — Subcutaneous