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New Vaccine COH04S1 vs. mRNA COVID-19 Vaccine for Blood Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm I (GEO-CM04S1)
- Group 2: Arm II (SOC mRNA SARS-CoV-2 vaccine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
To what extent is the patient population engaged in this research project?
"Affirmative. According to the information available on clinicaltrials.gov, this medical trial is actively enrolling participants; it was initially posted on September 27th 2021 and its most recent update occurred on November 2nd 2021. The study intends to admit 240 patients across a single site."
Are there other research initiatives studying the efficacy of a COVID-19 Vaccine?
"Currently, the research efforts on a COVID-19 Vaccine are extensive. 26 trials are in progress, with 5 of them reaching phase 3. Although Miami is the epicentre for this work, 180 other sites have been enlisted to participate as well."
Are there any vacancies left in this trial for participants?
"As verified on clinicaltrials.gov, this trial is presently taking in patients. It was first made available to the public on September 27th 2021 and recently updated on November 2nd 2021."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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