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NCT04269265 · ClinicalTrials.gov registry record · Phase 1
The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination
A Phase 1 study of Yellow Fever, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 2
- Study locations
NCT04269265: Completed Phase 1 study of Yellow Fever, sponsored by University of Minnesota.
NCT04269265 is a Phase 1 study of Yellow Fever that has completed, run by University of Minnesota. The registered enrollment target is 43 participants, below the 331-participant average among 3 other Yellow Fever trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04269265, a Phase 1 study of Yellow Fever, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 2
- Study locations
Study Summary
Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response.
Primary Outcome
Peak titer of neutralizing antibody to yellow fever vaccination. Outcome reported as Log YF Antibody titer.
Conditions Studied
Interventions
- BIOLOGICAL Yellow Fever Vaccine
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
Other
- Joint Clinical Research Centre - Kampala
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2023-10-23 |
| Phase | Phase 1 |
What the finished NCT04269265 record still lists
NCT04269265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 331-participant average among 3 other Yellow Fever trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Yellow Fever appearing as the primary indexed condition, and to 1 intervention - of which Yellow Fever Vaccine is the first listed.
NCT04269265 reports a single indexed study location in Minnesota, Other.
Frequently Asked Questions
What is clinical trial NCT04269265 about?
NCT04269265 is a clinical study titled "The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination". Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda...
What is the current status of trial NCT04269265?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2020-07-01. Estimated completion is 2023-10-23.
What conditions does trial NCT04269265 study?
This clinical trial studies the following conditions: Yellow Fever.
What interventions are being tested in trial NCT04269265?
The interventions under investigation include: Yellow Fever Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04269265?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04269265 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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