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

This study has been terminated.
(Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.)
Sponsor:
Information provided by:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00387738
First received: October 11, 2006
Last updated: September 8, 2010
Last verified: September 2010
History of Changes
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources

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: March 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TOLAMBA™ dose-intense regimen
 Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Other Name: TOLAMBA™
Experimental: 2
TOLAMBA™ lower-dose regimen
 Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Other Name: TOLAMBA™
Placebo Comparator: 3 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

Additional Information:
Dynavax Web Page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eduardo Martins, MD, DPhil / Vice President, Clinical Development, Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00387738     History of Changes
Other Study ID Numbers: DV1-SAR-09
Study First Received: October 11, 2006
Last Updated: September 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:
Ragweed
Allergy
Allergic
Rhinitis
Hay Fever
 Seasonal
Treatment
Immunotherapy
Vaccine

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Respiratory Tract Infections
Histamine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013