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

Sponsored by:	Dynavax Technologies Corporation
Information provided by:	Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:	NCT00387738

Purpose

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.

Condition	Intervention	Phase
Rhinitis, Allergic, Seasonal	Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate Biological: Histamine base	Phase II

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Histamine Histamine dihydrochloride Histamine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults

Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:

Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment:	738
Study Start Date:	April 2006
Study Completion Date:	June 2007
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TOLAMBA™ dose-intense regimen	Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate Escalating doses, 6 weekly subcutaneous (under the skin) injections
2: Experimental TOLAMBA™ lower-dose regimen	Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate Escalating doses, 6 weekly subcutaneous (under the skin) injections
3: Placebo Comparator	Biological: Histamine base Escalating doses, 6 weekly subcutaneous (under the skin) injections

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387738

Show 28 Study Locations

Sponsors and Collaborators

Dynavax Technologies Corporation

Investigators

Study Director:

Eduardo Martins, MD, DPhil

Dynavax Technologies Corporation

More Information

American Academy of Allergy, Asthma & Immunology This link exits the ClinicalTrials.gov site

Dynavax Web Page This link exits the ClinicalTrials.gov site

Responsible Party:	Dynavax Technologies Corporation ( Eduardo Martins, MD, DPhil / Vice President, Clinical Development )
Study ID Numbers:	DV1-SAR-09
Study First Received:	October 11, 2006
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00387738
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:

Ragweed
Allergy
Allergic
Rhinitis
Hay Fever

Seasonal
Treatment
Immunotherapy
Vaccine

Study placed in the following topic categories:

Fever
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Histamine phosphate
Rhinitis
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009