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

Running, not enrolling · Phase 2

Conditions studied: COVID-19 Infection, Hematopoietic and Lymphoid System Neoplasm, Leukemia, Lymphoma, Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT04977024

Run by

GeoVax, Inc.

People needed

63

Starts

2021-09-27

Expected to finish

2027-12-31

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented informed consent of the participant
• Age >=18 years
• Eastern Cooperative Oncology Group (ECOG) =<1
• Allogeneic or autologous hematopoietic cell transplant (HCT), cellular therapy (chimeric antigen receptor [CAR] T-cell) recipients who are at >= 3 months of infusion date of respective regimen
• Platelets >= 50,000/mm\^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• White blood cells (WBCs) >= 1000/mm\^3 (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• Total bilirubin < 1.5 X upper limit of normal (ULN) (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• Aspartate aminotransferase (AST) < 2.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• Alanine aminotransferase (ALT) < 2.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• Creatinine < 1.5 X ULN (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated)
• Negative COVID-19 PCR test
• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (to be performed within 30 days prior to day 0 of protocol therapy unless otherwise stated). If the urine pregnancy test is inconclusive a serum pregnancy test will be required
• Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last dose of protocol therapy
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

You may not qualify if…

• Systemic corticosteroids required for chronic conditions at doses > 0.5mg/kg/day prednisone equivalent within 7 days of enrollment
• Prior Evusheld or other anti-SARS CoV-2 prophylaxis < 2 weeks prior to enrollment
• Therapies that cause profound T-cell or B cell depletion within 30 days of enrollment
• Maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors, Janus kinase inhibitors) within 30 days of enrollment
• Received investigational or licensed SARS-CoV-2 vaccines after their qualifying cellular therapy. Patients who received a SARS- CoV-2 vaccine prior to cellular therapy are eligible for this trial, as revaccination for these patients (e.g. flu and shingles vaccine) is standard of care.
• Received a live vaccine ≤30 days prior to administration of study vaccine or subjects who are =< 2 weeks within administration of inactivated vaccines (e.g. influenza vaccine). Flu shots are allowed > 2 weeks before the first injection and > 2 weeks post 2nd injection
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to vaccine agents
• History of adverse event with a prior smallpox vaccination
• Any MVA vaccine or poxvirus vaccine in the last 12 months
• History (suspected or confirmed) of myocarditis or pericarditis
• Clinically significant uncontrolled illness
• Females only: Pregnant or breastfeeding
• Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
• Anyone considered to be in a vulnerable population as defined in 45 CFR §46.111 (a)(3) and 45 CFR §46, Subparts B-D

Where it is running

• 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

Full record on ClinicalTrials.gov

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