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

Dynavax Technologies Corporation

Status and phase: Terminated; Phase 2

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate; Biological: Histamine base

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387738

DV1-SAR-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 738 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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738 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

TOLAMBA™ dose-intense regimen

Treatment:

Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate

2

Experimental group

Description:

TOLAMBA™ lower-dose regimen

Treatment:

Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate

3

Placebo Comparator group

Treatment:

Biological: Histamine base