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NCT04639466 · ClinicalTrials.gov registry record · Phase 1
A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
A Phase 1 study, sponsored by GeoVax.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT04639466 is a Phase 1 study that has completed, run by GeoVax. The registered enrollment target is 119 participants.
The verdict
NCT04639466, a Phase 1 study, has completed, sponsored by GeoVax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.
Interventions
- DRUG Placebo Administration
- BIOLOGICAL Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2025-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04639466
The ClinicalTrials.gov registry entry for NCT04639466 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GeoVax, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Administration is the first listed.
NCT04639466 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04639466 about?
NCT04639466 is a clinical study titled "A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection". This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrat...
What is the current status of trial NCT04639466?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2020-11-19. Estimated completion is 2025-12-03.
What interventions are being tested in trial NCT04639466?
The interventions under investigation include: Placebo Administration (DRUG), Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04639466?
This trial is sponsored by GeoVax, which has 4 total clinical trials registered on ClinicalTrials.gov.
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