Seasonal Allergic RhinitisPhase 2NCT00346086
DNA Vaccine for Ragweed Allergic Adults
A Phase 2 study testing AIC (Amb a 1 Immunostimulatory Conjugate) in people with Seasonal Allergic Rhinitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- AIC (Amb a 1 Immunostimulatory Conjugate)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2001to 21 Aug 2001
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult men and women 18 to 60 years of age;
- Who provide informed consent;
- Have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy;
- Exhibit a positive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge;
- Are in general good health; and are available for the duration of the study.
Who cannot join
- Individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded.
- Those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: A Phase II Observer-blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety, Tolerability, and Immunogenicity of Subcutaneously Administered Dynavax Amb a 1 Immunostimulatory Oligodeoxyribonucleotide Conjugate (AIC) in Ragweed-Allergic Adults (Sponsor's Protocol NRH01)
Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.
Read the detailed description
Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell assays, cytokine assays, nasal provocation).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- AIC (Amb a 1 Immunostimulatory Conjugate)
- Keywords
- CpG oligonucleotide vaccine, ragweed immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIC (Amb a 1 Immunostimulatory Conjugate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment on nasal allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study start18 May 2001
- Primary completion21 Aug 2001
- Study completion21 Aug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter S Creticos, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346086
- Sponsor's protocol ID
- AAC01-03-27-01
- Other IDs
- NRH01
- Status last verified
- Dec 2018
- First submitted
- 27 Jun 2006
- Last updated
- 13 Dec 2018
- Results posted
- No
Publications
Creticos PS, Schroeder JT, Hamilton RG, Balcer-Whaley SL, Khattignavong AP, Lindblad R, Li H, Coffman R, Seyfert V, Eiden JJ, Broide D; Immune Tolerance Network Group. Immunotherapy with a ragweed-toll-like receptor 9 agonist vaccine for allergic rhinitis. N Engl J Med. 2006 Oct 5;355(14):1445-55. doi: 10.1056/NEJMoa052916.
PubMed 17021320
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Observer-blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety, Tolerability, and Immunogenicity of Subcutaneously Administered Dynavax Amb a 1 Immunostimulatory Oligodeoxyribonucleotide Conjugate (AIC) in Ragweed-Allergic Adults (Sponsor's Protocol NRH01)
- ClinicalTrials.gov ID
- NCT00346086
- Acronym / sponsor ID
- AAC01-03-27-01
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- CpG oligonucleotide vaccine, ragweed immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 18 May 2001 (actual)
- Primary completion
- 21 Aug 2001 (actual)
- Study completion
- 21 Aug 2001 (actual)
- First posted
- 29 Jun 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.
Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.
Detailed description
Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell assays, cytokine assays, nasal provocation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult men and women 18 to 60 years of age;
- Who provide informed consent;
- Have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy;
- Exhibit a positive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge;
- Are in general good health; and are available for the duration of the study.
Key exclusion criteria (2 listed)
- Individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded.
- Those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.
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 |
|---|---|---|
| AIC (Amb a 1 Immunostimulatory Conjugate) | Drug | – |
Primary outcome
Effect of treatment on nasal allergen challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Derived from this study: PubMed 17021320Creticos PS, Schroeder JT, Hamilton RG, Balcer-Whaley SL, Khattignavong AP, Lindblad R, Li H, Coffman R, Seyfert V, Eiden JJ, Broide D; Immune Tolerance Network Group. Immunotherapy with a ragweed-toll-like receptor 9 agonist vaccine for allergic rhinitis. N Engl J Med. 2006 Oct 5;355(14):1445-55. doi: 10.1056/NEJMoa052916.
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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.
Peter S Creticos, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIC (Amb a 1 Immunostimulatory Conjugate) in people with Seasonal Allergic Rhinitis, run by Johns Hopkins University at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of treatment on nasal allergen challenge. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346086, which also lists 1 linked publication.
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 13 Dec 2018.