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Virus Therapy
New Vaccine COH04S1 vs. mRNA COVID-19 Vaccine for Blood Cancer
Phase 2
Recruiting
Led By Sanjeet S Dadwal
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=18 years
Eastern Cooperative Oncology Group (ECOG) =< 2
Must not have
Females only: Pregnant or breastfeeding
Clinically significant uncontrolled illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 365 days
Awards & highlights
Summary
This trial is studying a new vaccine, COH04S1, to see if it is better than the EUA SARS-CoV-2 vaccine in reducing the chances of contracting COVID-19 or developing a severe form of COVID-19 disease in patients with blood cancer who have received stem cell transplant or cellular therapy.
Who is the study for?
Adults with blood cancers who've had stem cell transplants or CAR T-cell therapy at least 3 months ago. They must be in good health, not pregnant, agree to birth control, and have normal organ function tests. Those who got a COVID-19 vaccine after their therapy or have certain medical treatments or conditions are excluded.
What is being tested?
The trial is testing GEO-CM04S1, a synthetic MVA-based SARS-CoV-2 vaccine against standard mRNA vaccines in blood cancer patients post-transplant or cellular therapy. It aims to see if GEO-CM04S1 offers better protection from COVID-19.
What are the potential side effects?
Potential side effects aren't specified but may include typical vaccine reactions like soreness at the injection site, fever, fatigue, muscle pain. Severe allergic reactions could occur but are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can perform all my self-care but may not be able to do heavy physical work.
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I am fully active and can carry on all pre-disease activities without restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
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I do not have any uncontrolled serious illnesses.
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I haven't had treatments that significantly reduce my immune cells in the last 30 days.
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I take more than 0.5mg/kg/day of steroids for a chronic condition.
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I have had myocarditis or pericarditis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 365 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biological response
Secondary study objectives
Antigen specific T cell responses to the COH04S1 vaccine
Humoral immunity
Incidence of Severe coronavirus disease 2019 (COVID-19)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (SOC mRNA SARS-CoV-2 vaccine)Experimental Treatment2 Interventions
Patients receive one dose of SOC mRNA SARS-CoV-2 vaccine IM in the upper arm on days 0 and 28.
Group II: Arm I (GEO-CM04S1)Experimental Treatment2 Interventions
Patients receive one dose of GEO-CM04S1 IM in the upper arm on days 0 and 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVID-19 Vaccine
2023
Completed Phase 3
~16730
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,297 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,760 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
GeoVax, Inc.Lead Sponsor
5 Previous Clinical Trials
267 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am capable of becoming pregnant or fathering a child.I have not received any MVA or poxvirus vaccine in the last year.I haven't taken any maintenance therapies like rituximab in the last 30 days.Your total bilirubin level should be within a certain range, which will be checked within 30 days before starting the treatment.I had a stem cell or CAR T-cell therapy at least 3 months ago.I can perform all my self-care but may not be able to do heavy physical work.I got a COVID-19 vaccine after my cell therapy, or before it and can be revaccinated.Your white blood cell count is at least 1000 per cubic millimeter.I am not pregnant or breastfeeding.I do not have any uncontrolled serious illnesses.You have had allergic reactions to similar vaccines before.I haven't had treatments that significantly reduce my immune cells in the last 30 days.You had a bad reaction after getting a smallpox shot before.I am fully active and can carry on all pre-disease activities without restriction.Your liver enzyme levels (ALT) should be below a certain level.You must have a negative COVID-19 test.I haven't received Evusheld or any COVID-19 prevention treatment in the last 2 weeks.I take more than 0.5mg/kg/day of steroids for a chronic condition.Your kidney function, as measured by creatinine levels, should be within a certain range.I have had myocarditis or pericarditis.Your blood platelet count is at least 50,000 per cubic millimeter.Your AST levels should be less than 2.5 times the normal upper limit.I haven't had a live vaccine in the last 30 days or an inactivated vaccine in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (GEO-CM04S1)
- Group 2: Arm II (SOC mRNA SARS-CoV-2 vaccine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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