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DNA Vaccine for Ragweed Allergic Adults

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StatusDovršeno
Sponzori
Johns Hopkins University

Ključne riječi

Sažetak

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.

Opis

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).

Datumi

Posljednja provjera: 11/30/2018
Prvo podneseno: 06/26/2006
Predviđena prijava poslana: 06/26/2006
Prvo objavljeno: 06/28/2006
Posljednje ažuriranje poslano: 12/11/2018
Posljednje ažuriranje objavljeno: 12/12/2018
Stvarni datum početka studija: 05/17/2001
Procijenjeni datum primarnog završetka: 08/20/2001
Procijenjeni datum završetka studije: 08/20/2001

Stanje ili bolest

Seasonal Allergic Rhinitis

Intervencija / liječenje

Drug: AIC (Amb a 1 Immunostimulatory Conjugate)

Faza

Faza 2

Kriterij prihvatljivosti

Dobni uvjeti za studiranje 18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studijAll
Prihvaća zdrave volontereDa
Kriteriji

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.

Ishod

Primarne mjere ishoda

1. Effect of treatment on nasal allergen challenge [undefined]

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