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NCT04770649 · ClinicalTrials.gov registry record
Vaccine Observation to Include All Communities for Equitable Science
A clinical trial, sponsored by Persephone Biosciences.
- Terminated
- Registry status
- 15
- Enrollment target
NCT04770649 is a clinical trial that was terminated before completion, run by Persephone Biosciences. The registered enrollment target is 15 participants.
The verdict
NCT04770649 was terminated before completion, sponsored by Persephone Biosciences.
- TERMINATED
- Registry status
- 15 participants
- Enrollment target
Study Summary
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool and blood samples. It has recently been shown that the gut microbiome, the collection of microbes that line our GI tract, play a significant role in vaccine immune response and severe complications from COVID-19. The identification of biomarkers may aid in predicting response to vaccination and are critical towards improving vaccine-induced immunity. These real-world patient derived biomarkers could be used as interventional targets for the design of innovative adjuvant co-therapies that can boost an effective immune response to the vaccine, enhancing efficacy for a broader population, including those at most risk. Subjects who meet the entry criteria will provide two samples each of blood, one prior to and one following vaccine administration. Follow-up questionnaires will be sent at 3, 6, 9, and 12 months to determine if participants have contracted COVID-19 or have experienced any adverse effects of the vaccine. Nasal swab samples will also be collected from participants that have contracted COVID-19. The samples will be analyzed to determine the impact of gut microbiome composition and function on the immune system and vaccine efficacy.
Interventions
- BIOLOGICAL COVID-19 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770649
The ClinicalTrials.gov registry entry for NCT04770649 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Persephone Biosciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which COVID-19 vaccine is the first listed.
NCT04770649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04770649 about?
NCT04770649 is a clinical study titled "Vaccine Observation to Include All Communities for Equitable Science". VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool and blood samples. It has recently been shown that the gut microbiome,...
What is the current status of trial NCT04770649?
This trial is currently terminated. The enrollment target is 15 participants. The study started on 2021-04-01. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04770649?
The interventions under investigation include: COVID-19 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04770649?
This trial is sponsored by Persephone Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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