DNA Vaccine for Ragweed Allergic Adults

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346086

Enrollment

Registered

2006-06-29

Start date

2001-05-18

Completion date

2001-08-21

Last updated

2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

CpG oligonucleotide vaccine, ragweed immunotherapy

Brief 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. 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).

Interventions

DRUGAIC (Amb a 1 Immunostimulatory Conjugate)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Effect of treatment on nasal allergen challenge	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026