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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: Completed Phase 1 study, sponsored by GeoVax.
NCT04639466 is a Phase 1 study that has completed, run by GeoVax. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluated based on the Division of Microbiology and Infectious Diseases criteria.
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 |
What the finished NCT04639466 record still lists
NCT04639466 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Administration is the first listed.
NCT04639466 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04639466's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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