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

Phase 2

Terminated

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Biological: Histamine base; Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate

• Registration Number: NCT00387738
• Lead Sponsor: Dynavax Technologies Corporation

Brief Summary

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.

Detailed Description

Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.

Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-13
• Primary Completion: 2007-05
• Study Completion: 2008-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 738

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Histamine base	-
1	Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate	TOLAMBA™ dose-intense regimen
2	Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate	TOLAMBA™ lower-dose regimen

Primary Outcome Measures

Name	Time	Method
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.	Two years

Trial Locations

Locations (27)

Research Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Clinical Research of The Ozarks; 🇺🇸 Rolla, Missouri, United States

Atlanta Allergy & Asthma Clinic; 🇺🇸 Stockbridge, Georgia, United States

Clinical Research Institute; 🇺🇸 Plymouth, Minnesota, United States

Clinical Research of the Ozarks; 🇺🇸 Warrensburg, Missouri, United States

Sneeze, Wheeze, and Itch Associates; 🇺🇸 Normal, Illinois, United States

Center Of Research Excellence; 🇺🇸 Oxford, Alabama, United States

Asthma, Allergy & Sinus Center; 🇺🇸 Greenfield, Wisconsin, United States

Asthma & Allergy Research Associates; 🇺🇸 Upland, Pennsylvania, United States

Clinical Research Center; 🇺🇸 Saint Louis, Missouri, United States

Midwest Allergy & Asthma Clinic; 🇺🇸 Omaha, Nebraska, United States

Allergy & Respiratory Center; 🇺🇸 Canton, Ohio, United States

Bernstein Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Princeton Center for Clinical Research; 🇺🇸 Skillman, New Jersey, United States

AARA Research Center; 🇺🇸 Dallas, Texas, United States

Allergy, Asthma and Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Wisconsin Madison Medical School; 🇺🇸 Madison, Wisconsin, United States

Clinical Research of Atlanta; 🇺🇸 Stockbridge, Georgia, United States

Pharmaceutical Research & Consulting; 🇺🇸 Dallas, Texas, United States

Sylvana Research; 🇺🇸 San Antonio, Texas, United States

Kerrville Allergy and Asthma Associates; 🇺🇸 Kerrville, Texas, United States

Central Texas Health Research; 🇺🇸 New Braunfels, Texas, United States

Advanced Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

Asthma & Allergy Center; 🇺🇸 Papillion, Nebraska, United States

Asthma and Allergy Research Center; 🇺🇸 Minneapolis, Minnesota, United States

Allergy & Asthma Center; 🇺🇸 High Point, North Carolina, United States