NCT00387738

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

A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 738 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate	Escalating doses, 6 weekly subcutaneous (under the skin) injections
BIOLOGICAL	Histamine base	Escalating doses, 6 weekly subcutaneous (under the skin) injections

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-05-01
• Completion: 2008-03-01
• First posted: 2006-10-13
• Last updated: 2019-04-16

Locations

28 sites across 1 country: United States