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Virus Therapy
Synthetic MVA-based Vaccine for COVID-19
Verified Trial
Phase 1
Recruiting
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
Timeline
Screening 3 days
Treatment Varies
Follow Up during 1 year of observation
Awards & highlights
Study 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.
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antibody levels to SARS CoV-2 Spike protein (Phase II)
Fold increase of Spike IgG levels (Phase II)
Incidence of adverse events (Phase I)
+1 moreSecondary outcome measures
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)
+11 moreOther outcome measures
In depth analysis of Th1 (IFN-gamma, TNF-alpha, IL-2)/Th2 (IL-4, IL-6, IL-13) cytokine expression via intracellular cytokine staining on selected samples (Phase I)
Incidence of COVID-19 in placebo group (Phase I)
Incidence of coronavirus 2019 (COVID-19) infection (Phase I)
+4 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
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
318 Total Patients Enrolled
City of Hope Medical CenterOTHER
565 Previous Clinical Trials
1,921,271 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,816 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count of this experiment?
"Affirmative. The information on clinicaltrials.gov reveals that this trial, initially published on November 19th 2020, is still actively seeking participants. Two medical centres are looking for a total of 189 patients to join the study."
Answered by AI
What earlier research has been conducted regarding Vaccine Therapy?
"Currently, 26 Vaccine Therapy trials are ongoing. Of those studies, 5 have reached Phase 3 of the clinical trial process. Although Miami is the primary site for such research initiatives, there are 180 locations running these experiments across America."
Answered by AI
Can individuals younger than 20 years of age take part in this medical experiment?
"The parameters for entry into this study necessitate that all participants are between 18 and 55 years old."
Answered by AI
Is eligibility for this trial open to me?
"This clinical trial is enrolling 189 individuals who have tested positive for Covid-19, aged 18 to 55. The main criteria they must meet are as follows: PHASE I: Age: At least 18 and no older than 55 years of age."
Answered by AI
Is it possible to join the research endeavor presently?
"Yes, the information publicly accessible on clinicaltrials.gov attests that this medical investigation is currently recruiting patients. This study was posted to the database on November 19th 2020 and last revised December 15th 2021; it seeks 189 participants from 2 different sites."
Answered by AI
Has Vaccine Therapy obtained government endorsement from the FDA?
"Vaccine Therapy has mostly been studied in a preclinical setting, rendering it a score of 1 on our safety scale. As this is only Phase 1 trial, there is limited data confirming both its efficacy and safety."
Answered by AI
Who else is applying?
What state do they live in?
Puerto Rico
California
What site did they apply to?
City of Hope Comprehensive Cancer Center
Research Site - Claremont
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
To help others out. I want the vaccines. Help medical studies. For being able to help.
PatientReceived no prior treatments
Why not. Help himanity.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Where? How many visits? When would it take place? How long. How many visits?
PatientReceived 2+ prior treatments
Any location in Orange County? How long will the screening(s) take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Research Site - Claremont: < 24 hours
Average response time
- < 2 Days
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