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SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
Sponsor: GeoVax, Inc.
Summary
This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated as COH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce antibodies against SARS-CoV-2 that would block the virus from entering healthy cells. The immune system also grows new disease fighting T cells that can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapy may work better in reducing the chances of contracting coronavirus disease 2019 (COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancer compared to SOC mRNA SARS-CoV-2 vaccine.
Official title: A Phase 2 Randomized, Multi-center Study of GEO-CMO4S1 (SARS-CoV-2 Vaccine) Versus mRNA SARS-CoV-2 Vaccine in Patients Post Cellular Therapy for Hematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2021-09-27
Completion Date
2027-12-31
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
COVID-19 Vaccine
Receive SOC mRNA SARS-CoV-2 vaccine IM
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Given IM
Locations (6)
City of Hope Medical Center
Duarte, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
U Mass Chan Medical School
Worcester, Massachusetts, United States
SUNY-Stony Brook
Stony Brook, New York, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States