Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346086
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2006-06-27
Brief Title:
DNA Vaccine for Ragweed Allergic Adults
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
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 Sponsors Protocol NRH01
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NRH01 | None | None | None |