DNA Vaccine for Ragweed Allergic Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-18

Study Completion Date

2001-08-21

Brief Summary

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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

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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

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Seasonal Allergic Rhinitis

Keywords

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CpG oligonucleotide vaccine ragweed immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AIC (Amb a 1 Immunostimulatory Conjugate)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter S Creticos, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 17021320 (View on PubMed)

Other Identifiers

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NRH01

Identifier Type: -

Identifier Source: secondary_id

AAC01-03-27-01