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

NCT04977024 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 21163NCI-2021-05556P30CA033572
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

COVID-19 Infection; Hematopoietic and Lymphoid System Neoplasm; Leukemia; Lymphoma; Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Biological response

  Based on at least a 3-fold increase in severe acute respiratory syndrome coronavirus 2 (SARSCoV-2)- neutralizing antibodies or interferon (IFN)-gamma levels. Will compare the immune response at day 28 post the second injection between GEO-CM04S1 and SOC mRNA SARS-CoV-2 vaccine using a one-sided stratified Cochran-Mantel-Haenszel test. The point estimate and 95% confidence interval will be calculated per arm for immune response at day 28 post the second injection. Bar charts will be generated to show the immune response rate by arm overall, and by arm and strata.

  At 28 days post the second vaccine injection

Secondary Outcomes (10)

• Incidence of moderate adverse events (AEs)

  Up to 365 days

• Incidence of unacceptable AEs

  Up to 365 days

• Non-relapse mortality

  Up to 365 days

• Incidence of graft-versus-host disease (GVHD)

  Up to 365 days

• Incidence of Severe coronavirus disease 2019 (COVID-19)

  Up to 365 days

Study Arms (2)

Arm I (GEO-CM04S1)

EXPERIMENTAL

Patients receive one dose of GEO-CM04S1 IM in the upper arm on days 0 and 28.

Other: Diagnostic Laboratory Biomarker Analysis; Biological: Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1

Arm II (SOC mRNA SARS-CoV-2 vaccine)

EXPERIMENTAL

Patients receive one dose of SOC mRNA SARS-CoV-2 vaccine IM in the upper arm on days 0 and 28.

Interventions

COVID-19 Vaccine BIOLOGICAL

Receive SOC mRNA SARS-CoV-2 vaccine IM

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (GEO-CM04S1)

Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1 BIOLOGICAL

Given IM

Also known as: COH04S1, SARS-CoV-2 Vaccine COH04S1, sMVA-based SARS-CoV-2 Vaccine COH04S1, GEO-CM04S1

Arm I (GEO-CM04S1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• GeoVax, Inc.: lead

Study Sites (6)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

U Mass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

SUNY-Stony Brook

Stony Brook, New York, 11794, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

COVID-19; Leukemia; Lymphoma; Multiple Myeloma

Interventions

COVID-19 Vaccines; COH04S1 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Chief Medical Officer

  GeoVax, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 26, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (6)