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

NCT04977024 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-02-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

Given IM

BIOLOGICAL

COVID-19 Vaccine

Receive SOC mRNA SARS-CoV-2 vaccine IM

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • GeoVax, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · GeoVax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04977024 on ClinicalTrials.gov