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

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ClinicalTrials.gov Identifier: NCT00387738
Recruitment Status : Terminated (Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.)
First Posted : October 13, 2006
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate Biological: Histamine base Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. [ Time Frame: Two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387738


  Show 28 Study Locations
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation

Additional Information:
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00387738     History of Changes
Other Study ID Numbers: DV1-SAR-09
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IND for Tolamba was withdrawn, it was reported to the agency that there was no plan to conduct clinical studies with this compound. [per email from EA 18Dec2015. 3/1/2017 - No update

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

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