Immunological Data Discovery Index
Immunological Data Discovery Index
| identifier: | SDY167 |
| description: |
The primary objective was to evaluate the safety and tolerability of an investigational vaccine VRC-AVIDNA036-00-VP in humans at doses 1 mg and 4 mg administered intramuscularly using a needle-free injection system. The secondary objectives included evaluation of whether VRC-AVIDNA036-00-VP (at doses 1 mg and 4 mg) induced antibodies as assessed by an HAI assay at Day 0 and Week 12. Exploratory analyses included evaluation of the immunogenicity of VRC-AVIDNA036-00-VP at doses 1 mg and 4 mg using intracellular cytokine staining, ELISpot, neutralizing antibody assay, HAI assay to H1 or H3HA or other immunological assays at time intervals between Day 0 and Week 42.
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| aggregation: |
instance of dataset
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| refinement: |
2 - Complete set of descriptive data and results, as ascertained by ImmPort.
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| availability: |
available with registration
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| primaryPublications: |
22956656 |
| isAbout: |
To evaluate the safety and tolerability in humans of VRC-AVIDNA036-00-VP at a dose of 1 mg and 4 mg administered intramuscularly using a needle-free injection system.
To evaluate whether VRC-AVIDNA036-00-VP at a dose of 1 mg and 4 mg induces antibodies to H5 HA as assessed by an HAI assay at Day 0 and Week 12.
To evaluate the immunogenicity of VRC-AVIDNA036-00-VP at a dose of 1 mg and 4 mg administered intramuscularly using a needle-free injection system as indicated by intracellular cytokine staining, ELISpot, neutralizing antibody assay, HAI to H1 or H3 or other immunological assays at intervals between Day 0 and Week 42.
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| authorizations: |
registration required
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| accessURL: |
http://clinicaltrials.gov/ct2/show/NCT00408109 https://aspera-immport.niaid.nih.gov:9443/browser?path=SDY167 |
| landingPage: |
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY167 |
| clinical trial: | clinical trial |
| study category: | Vaccine Response |
| study type: | Interventional |
| subject species: | Homo sapiens |
| biosample type: | Whole blood |
| subject gender: | Both |
| assay type: |
ELISA ELISPOT Flow Cytometry Hemagglutination Inhibition Virus Neutralization |
| name: |
Influenza A Virus, H5N1 Subtype
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| fullName: |
Julie Ledgerwood
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| affiliations: |
Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID)
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| roles: |
principal investigator
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| name: |
VRC304 - A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP) Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults
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| size: |
45
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| name: |
NIAID Vaccine Research Center (VRC)
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| output: |
ELISA
ELISpot
Flow Cytometry
Hemagglutinin Inhibition Assay
Neutralization Assay
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| studyGroups: |
1 mg vaccine arm: The 1 mg vaccine arm received three 1 mg IM injections at least 21 days between injections
4 mg vaccine arm: The 4 mg vaccine arm received three 4 mg IM injections at least 21 days between injections
placebo arm: The placebo arm received three PBS IM injections at least 21 days between injections
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| description: |
VRC304 - A Phase I, double-blind, placebo-controlled, randomized, dose escalation study to evaluate safety, tolerability, and immunogenicity of a recombinant DNA vaccine against the influenza virus hemagglutinin H5.
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| identifier: |
10.21430/M3SGHW16WZ
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| startDate: |
2006-12-21
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| name: |
ImmPort
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| identifier: |
SCR:012804
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| homePage: |
http://www.immport.org |
