SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
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.
Timeline
- Start
- 2021-09-27
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
release “while the mRNA control arm of the study failed to meet the predetermined primary endpoint” reads as missed primary endpoint geovax.com ↗
release “while the mRNA control arm of the study failed to meet the predetermined primary endpoint” reads as missed primary endpoint geovax.com ↗
release “met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL)” reads as met primary endpoint geovax.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | COVID-19 Vaccine | Vaccine | — | Intramuscular |
| Subject | GEO-CM04S1 | Vaccine | 2.5e+08 unknown | Intramuscular |