← Back to Search

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
No Placebo-Only Group

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 below
Select...
I am 18 years old or older.
Select...
I can perform all my self-care but may not be able to do heavy physical work.
Select...
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.
Select...
I do not have any uncontrolled serious illnesses.
Select...
I haven't had treatments that significantly reduce my immune cells in the last 30 days.
Select...
I take more than 0.5mg/kg/day of steroids for a chronic condition.
Select...
I have had myocarditis or pericarditis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 365 days for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
602 Previous Clinical Trials
1,923,340 Total Patients Enrolled
89 Trials studying Leukemia
4,975 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,765 Total Patients Enrolled
1,534 Trials studying Leukemia
385,283 Patients Enrolled for Leukemia
GeoVax, Inc.Lead Sponsor
5 Previous Clinical Trials
265 Total Patients Enrolled

Media Library

Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04977024 — Phase 2
Leukemia Research Study Groups: Arm I (GEO-CM04S1), Arm II (SOC mRNA SARS-CoV-2 vaccine)
Leukemia Clinical Trial 2023: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 Highlights & Side Effects. Trial Name: NCT04977024 — Phase 2
Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977024 — Phase 2
~23 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top