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NCT05584735 · ClinicalTrials.gov registry record
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
A clinical trial, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 46
- Enrollment target
NCT05584735: Completed study, sponsored by University of Wisconsin, Madison.
NCT05584735 is a clinical trial that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05584735 has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 46 participants
- Enrollment target
Study Summary
This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.
Primary Outcome
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
Interventions
- BIOLOGICAL COVID-19 vaccine
- BIOLOGICAL Influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2025-03-20 |
What the finished NCT05584735 record still lists
NCT05584735 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which COVID-19 vaccine is the first listed.
NCT05584735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05584735 about?
NCT05584735 is a clinical study titled "Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine". This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.
What is the current status of trial NCT05584735?
This trial is currently completed. The enrollment target is 46 participants. The study started on 2023-11-03. Estimated completion is 2025-03-20.
What interventions are being tested in trial NCT05584735?
The interventions under investigation include: COVID-19 vaccine (BIOLOGICAL), Influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05584735?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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