NCT04977024

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: GeoVax, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the biological activity and the role of timing of 2 injections of GEO-CM04S1 vaccine administered at 2.5e8 PFU/dose compared to SOC mRNA vaccine. SECONDARY OBJECTIVES: I. Assess safety of GEO-CM04S1 vaccine. II. Evaluation of SARS-CoV-2 S and N-specific Th1 vs Th2 polarization. III. Evaluate T-cell levels and function. IV. Evaluate activated/cycling and memory phenotype markers. V. Evaluate durability of immune responses. VI. Evaluate maintenance of immunity that can be associated with protection over the study period. EXPLORATORY OBJECTIVE: I. Surveillance for incidental COVID-19 infection during follow-up (1 year). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I : Patients receive one dose of GEO-CM04S1 intramuscularly (IM) in the upper arm on days 0 and 28. ARM II : Patients receive one dose of SOC mRNA SARS-CoV-2 vaccine IM in the upper arm on days 0 and 28. After the completion of study treatment, patients are followed up at days 7, 90, 120, 180, and 365.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-27
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2021-07-26
• Last updated: 2026-02-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study