Rhinitis, Allergic, SeasonalPhase 2NCT00387738
Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
A Phase 2 study testing Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate and Histamine base in people with Rhinitis, Allergic, Seasonal, run by Dynavax Technologies Corporation at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate and Histamine base
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 738 participants
- Where
- 28 sitesUnited States
- Study dates
- Apr 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Allergy & Respiratory Center
Canton, Ohio, 44718
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Clinical Research of the Ozarks
Columbia, Missouri, 65203
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research & Consulting
Dallas, Texas, 75231
Asthma, Allergy & Sinus Center
Greenfield, Wisconsin, 53228
Allergy & Asthma Center
High Point, North Carolina, 27262
Research Center of Indiana
Indianapolis, Indiana, 46208
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028
University of Wisconsin Madison Medical School
Madison, Wisconsin, 53792
Advanced Healthcare
Milwaukee, Wisconsin, 53209
Asthma and Allergy Research Center
Minneapolis, Minnesota, 55416
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze, and Itch Associates
Normal, Illinois, 61761
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Midwest Allergy & Asthma Clinic
Omaha, Nebraska, 68130
Creighton University
Omaha, Nebraska, 68131
Center Of Research Excellence
Oxford, Alabama, 36203
Asthma & Allergy Center
Papillion, Nebraska, 68046
Clinical Research Institute
Plymouth, Minnesota, 55441
Clinical Research of The Ozarks
Rolla, Missouri, 65401
Sylvana Research
San Antonio, Texas, 78229
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Clinical Research Center
St Louis, Missouri, 63141
Atlanta Allergy & Asthma Clinic
Stockbridge, Georgia, 30281
Clinical Research of Atlanta
Stockbridge, Georgia, 30281
Asthma & Allergy Research Associates
Upland, Pennsylvania, 19013
Clinical Research of the Ozarks
Warrensburg, Missouri, 64093
About this 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
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.
Read the 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
- Being tested
- Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate, Histamine base
- Keywords
- Ragweed, Allergy, Allergic, Rhinitis, Hay Fever, Seasonal, Treatment, Immunotherapy, Vaccine
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugateBiological
Also called TOLAMBA™
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Histamine baseBiological
Escalating doses, 6 weekly subcutaneous (under the skin) injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TOLAMBA™ dose-intense regimen Receives: Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate |
| 2 | Experimental | TOLAMBA™ lower-dose regimen Receives: Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate |
| 3 | Placebo comparator | Not described Receives: Biological: Histamine base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2007
- Study completionMar 2008
Why it stopped: Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Martins, MD, DPhil, Study director, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387738
- Sponsor's protocol ID
- DV1-SAR-09
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2006
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
- ClinicalTrials.gov ID
- NCT00387738
- Acronym / sponsor ID
- DV1-SAR-09
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Ragweed, Allergy, Allergic, Rhinitis, Hay Fever, Seasonal, Treatment, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.
- Enrolment
- 738 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugateTOLAMBA™ dose-intense regimen |
| 2 | Experimental | Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugateTOLAMBA™ lower-dose regimen |
| 3 | Placebo comparator | Biological: Histamine base |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugateAlso: TOLAMBA™Escalating doses, 6 weekly subcutaneous (under the skin) injections | Biological | 1, 2 |
| Histamine baseEscalating doses, 6 weekly subcutaneous (under the skin) injections | Biological | 3 |
Primary outcome
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Time frame: Two years
Results and safety
The study was stopped early (reason given: Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- American Academy of Allergy, Asthma \& ImmunologyLink provided by the sponsor.
- Dynavax Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Martins, MD, DPhil study director
Dynavax Technologies Corporation
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate and Histamine base in people with Rhinitis, Allergic, Seasonal, run by Dynavax Technologies Corporation at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season, making it impossible to measure treatment effect.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.