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Virus Therapy
Synthetic MVA-based Vaccine for COVID-19
Claremont, CA
Phase 1 & 2
Waitlist Available
Led By John Zaia
Research Sponsored by GeoVax, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
PHASE II: Participants who would be at higher risk for severe COVID-19 according to known risk factors are excluded e.g. type 2 diabetes, obesity (BMI > 35), congestive heart failure (New York Heart Association Class >= I), history of coronary artery disease, cardiomyopathies, sickle cell disease, smoking, chronic kidney disease, immunocompromised state from solid organ transplant, or chronic obstructive pulmonary disease
PHASE II: Intensive cytotoxic therapies, B- or T-cell depleting therapies, or checkpoint inhibitors within 30 days of enrollment
Timeline
Screening 3 days
Treatment Varies
Follow Up during 1 year of observation
Summary
This trial is testing a vaccine to prevent COVID-19 infection. The vaccine is made of pieces of SARS-CoV-2 DNA placed into a synthetic virus (MVA). The trial will find the safe dose and side effects of the vaccine.
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Who is the study for?
This trial is for individuals who have received at least two COVID-19 vaccines, haven't had any vaccines in the last month, and are not currently on medications that affect the immune system. They should not have COVID-19 or a history of severe allergic reactions to vaccines. People with certain medical conditions or those taking corticosteroids recently are excluded.Check my eligibility
What is being tested?
The trial is testing COH04S1, a synthetic MVA-based SARS-CoV-2 vaccine designed to prevent COVID-19 infection. It involves determining the safest and most effective dose by comparing it with a placebo (a substance with no therapeutic effect).See study design
What are the potential side effects?
Potential side effects may include typical vaccine-related reactions such as soreness at injection site, fever, fatigue, headaches, muscle pain. Severe allergic reactions could occur but are monitored closely due to strict eligibility criteria.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions like severe diabetes, obesity, heart failure, or lung disease that increase my risk for severe COVID-19.
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I haven't had strong cancer treatments or immune therapies in the last 30 days.
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Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ during 1 year of observation
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~during 1 year of observation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Antibody levels to SARS CoV-2 Spike protein (Phase II)
Incidence of adverse events (Phase I)
Incidence of adverse events (Phase II)
Secondary study objectives
Antibody to SARS CoV-2 Spike protein (Phase II)
COVID-19 disease that is moderate, severe, or critical (Phase II)
Comparison of immunogenicity and adverse events (Phase I)
+5 moreOther study objectives
Incidence of COVID-19 in placebo group (Phase I)
Incidence of coronavirus 2019 (COVID-19) infection (Phase I)
Phenotype markers on the surface of antigen specific T cells elicited as a result of the COH04S1 vaccination (Phase II)
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase II Arm II (high dose COH04S1 booster)Experimental Treatment1 Intervention
Participants receive high dose COH04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity.
Group II: Phase II Arm I (low dose COH04S1 booster)Experimental Treatment1 Intervention
Participants receive low dose COH04S1 booster IM in non-dominant upper arm on day 1 in the absence of unacceptable toxicity.
Group III: Phase I Arm I (COH04S1)Experimental Treatment1 Intervention
Participants receive COH04S1 IM in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity.
Group IV: Phase I Arm II (COH04S1, placebo)Active Control2 Interventions
Participants receive COH04S1 IM in the non-dominant upper arm on day 0 and placebo IM in the non-dominant upper arm on day 28 in the absence of unacceptable toxicity.
Group V: Phase I Arm III (placebo)Placebo Group1 Intervention
Participants receive placebo IM in the non-dominant upper arm on day 0 and day 28 in the absence of unacceptable toxicity.
Find a Location
Closest Location:Research Site - Claremont· Claremont, CA· 1946 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GeoVax, Inc.Lead Sponsor
5 Previous Clinical Trials
316 Total Patients Enrolled
City of Hope Medical CenterOTHER
613 Previous Clinical Trials
1,923,920 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,047 Previous Clinical Trials
41,147,650 Total Patients Enrolled
John ZaiaPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
124 Total Patients Enrolled
Randy A TaplitzPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
Chief Medical OfficerPrincipal InvestigatorGeoVax, Inc.
132 Previous Clinical Trials
22,038 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe migraines but am on effective medication reducing them to less than one per month.I haven't had strong cancer treatments or immune therapies in the last 30 days.I do not have conditions like severe diabetes, obesity, heart failure, or lung disease that increase my risk for severe COVID-19.I have not had asthma, severe allergies, or used certain inhalers more than once in the last 3 months.You experience shortness of breath when lying down or doing everyday activities.I have not taken any corticosteroid medication in the last 14 days.You have a medical condition that could put healthcare workers at risk of contracting an infectious disease during the study.I have received a COVID-19 booster shot.I have not taken any corticosteroid medication in the last 14 days.I am taking medications that affect my immune system.You have had an allergic reaction to drugs or substances similar to the study drug.You had a bad reaction to a smallpox vaccine in the past.You have a history of asthma, anaphylaxis, or hives, or you take antihistamines or other inhalers regularly.You have had an allergic reaction to drugs that are similar to the study drug.I haven't had an MVA or poxvirus vaccine in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Arm I (COH04S1)
- Group 2: Phase I Arm II (COH04S1, placebo)
- Group 3: Phase I Arm III (placebo)
- Group 4: Phase II Arm I (low dose COH04S1 booster)
- Group 5: Phase II Arm II (high dose COH04S1 booster)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Coronavirus Disease Patient Testimony for trial: Trial Name: NCT04639466 — Phase 1 & 2