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

Phase 2TerminatedNCT00387738

Dynavax Technologies Corporation738 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

738

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugateBIOLOGICAL

Escalating doses, 6 weekly subcutaneous (under the skin) injections

Histamine baseBIOLOGICAL

Escalating doses, 6 weekly subcutaneous (under the skin) injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 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

Locations (28)

Outcomes

Primary Outcomes

Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.

Time frame: Two years

Data from ClinicalTrials.gov

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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

...and 18 more locations