Clinical trial NCT00387738: Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
Official title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Ragweed
Allergy
Allergic
Rhinitis
Hay Fever
Seasonal
Treatment
Immunotherapy
Vaccine
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Center Of Research Excellence
state: Alabama
city: Stockbridge
country: United States
facility: Atlanta Allergy & Asthma Clinic
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research of Atlanta
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze, and Itch Associates
state: Illinois
city: Indianapolis
country: United States
facility: Research Center of Indiana
state: Indiana
city: Minneapolis
country: United States
facility: Asthma and Allergy Research Center
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Columbia
country: United States
facility: Clinical Research of the Ozarks
state: Missouri
city: Rolla
country: United States
facility: Clinical Research of The Ozarks
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Center
state: Missouri
city: Warrensburg
country: United States
facility: Clinical Research of the Ozarks
state: Missouri
city: Omaha
country: United States
facility: Midwest Allergy & Asthma Clinic
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Papillion
country: United States
facility: Asthma & Allergy Center
state: Nebraska
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: High Point
country: United States
facility: Allergy & Asthma Center
state: North Carolina
city: Canton
country: United States
facility: Allergy & Respiratory Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Upland
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting
state: Texas
city: Kerrville
country: United States
facility: Kerrville Allergy and Asthma Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research
state: Texas
city: Greenfield
country: United States
facility: Asthma, Allergy & Sinus Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison Medical School
state: Wisconsin
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
Study officials:
affiliation: Dynavax Technologies Corporation
name: Eduardo Martins, MD, DPhil
role: STUDY_DIRECTOR
References: