Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

Stopped early · Phase 2

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.

Key facts

Study ID

NCT00387738

Run by

Dynavax Technologies Corporation

People needed

738

Starts

2006-04-01

Expected to finish

2008-03-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete
• Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season

You may not qualify if…

• Has had any hospital admissions for asthma
• Has smoked within the past year, or has a ≥10-pack per year smoking history
• Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™
• Has used Xolair within the past 12 months
• Has a history of anaphylaxis

Where it is running

• Center Of Research Excellence — Oxford, Alabama, United States
• Atlanta Allergy & Asthma Clinic — Stockbridge, Georgia, United States
• Clinical Research of Atlanta — Stockbridge, Georgia, United States
• Sneeze, Wheeze, and Itch Associates — Normal, Illinois, United States
• Research Center of Indiana — Indianapolis, Indiana, United States
• Asthma and Allergy Research Center — Minneapolis, Minnesota, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• Clinical Research of the Ozarks — Columbia, Missouri, United States
• Clinical Research of The Ozarks — Rolla, Missouri, United States
• Clinical Research Center — St Louis, Missouri, United States
• Clinical Research of the Ozarks — Warrensburg, Missouri, United States
• Midwest Allergy & Asthma Clinic — Omaha, Nebraska, United States
• Creighton University — Omaha, Nebraska, United States
• Asthma & Allergy Center — Papillion, Nebraska, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• Allergy & Asthma Center — High Point, North Carolina, United States
• Allergy & Respiratory Center — Canton, Ohio, United States
• Bernstein Clinical Research Center — Cincinnati, Ohio, United States
• Allergy, Asthma and Clinical Research Center — Oklahoma City, Oklahoma, United States
• Asthma & Allergy Research Associates — Upland, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Pharmaceutical Research & Consulting — Dallas, Texas, United States
• Kerrville Allergy and Asthma Associates — Kerrville, Texas, United States
• Central Texas Health Research — New Braunfels, Texas, United States
• Sylvana Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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