A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection (NCT04639466) | Clinical Trial Compass
CompletedPhase 1/2
A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
United States119 participantsStarted 2020-11-19
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PHASE I: Documented informed consent of the participant
* PHASE I: Age: \>= 18 years and \< 55 years
* PHASE I: Ability to read and understand English, Spanish, or Mandarin for consenting
* PHASE I: Platelets \>= 100,000/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: White blood cells (WBCs) 3,600-10,100/mm\^3 (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Total bilirubin \< 1.1 x upper limit of normal (ULN) (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Aspartate aminotransferase (AST) \< 1.5 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Alanine aminotransferase (ALT) \< 1.5 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Alkaline phosphatase (AP) \< 1.1 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Blood urea nitrogen (BUN) \< 1.25 x ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Creatinine less than or equal to the ULN (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Sodium 137-145 mEq/L (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Potassium 3.5-5.1 mEq/L (within 30 days prior to day 0 of protocol therapy unless otherwise stated)
* PHASE I: Carbon dioxide 22-30 mmol/L …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (Phase I)
Timeframe: Up to 365 days
2
Incidence of adverse events (Phase II)
Timeframe: Within the first 7 days following booster injection
3
Antibody levels to SARS CoV-2 Spike protein (Phase II)