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ACTIVE NOT RECRUITING
NCT04977024
PHASE2

SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer

Sponsor: GeoVax, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

COVID-19 Vaccine

Receive SOC mRNA SARS-CoV-2 vaccine IM

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

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