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NCT04977024

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

Active, enrolled Phase 2 Last updated 11 February 2026
What this trial tests

Phase 2 trial testing COVID-19 Vaccine in COVID-19 Infection in 63 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
27 September 2021
Primary endpoint
31 December 2026
31 December 2027

Quick facts

Lead sponsorGeoVax, Inc.
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment63
Start date27 September 2021
Primary completion31 December 2026
Estimated completion31 December 2027
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

GeoVax, Inc. — full company profile →

Who can join

18 and older, any sex, with COVID-19 Infection or Hematopoietic and Lymphoid System Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  2. T cell-oriented strategies for controlling the COVID-19 pandemic.
    Noh JY, Jeong HW, Kim JH, Shin EC. · · 2021 · cited 59× · PMID 34497383 · DOI 10.1038/s41577-021-00625-9
  3. Therapeutic cancer vaccines: From biological mechanisms and engineering to ongoing clinical trials.
    Sobhani N, Scaggiante B, Morris R, Chai D, et al · · 2022 · cited 57× · PMID 35759856 · DOI 10.1016/j.ctrv.2022.102429
  4. Synthetic multiantigen MVA vaccine COH04S1 protects against SARS-CoV-2 in Syrian hamsters and non-human primates.
    Chiuppesi F, Nguyen VH, Park Y, Contreras H, et al · · 2022 · cited 50× · PMID 35064109 · DOI 10.1038/s41541-022-00436-6
  5. Safety and immunogenicity of a synthetic multiantigen modified vaccinia virus Ankara-based COVID-19 vaccine (COH04S1): an open-label and randomised, phase 1 trial.
    Chiuppesi F, Zaia JA, Frankel PH, Stan R, et al · · 2022 · cited 43× · PMID 35287430 · DOI 10.1016/s2666-5247(22)00027-1
  6. Replicating Viral Vector-Based Vaccines for COVID-19: Potential Avenue in Vaccination Arena.
    Chavda VP, Bezbaruah R, Athalye M, Parikh PK, et al · · 2022 · cited 40× · PMID 35458489 · DOI 10.3390/v14040759
  7. Highly Attenuated Poxvirus-Based Vaccines Against Emerging Viral Diseases.
    Perdiguero B, Pérez P, Marcos-Villar L, Albericio G, et al · · 2023 · cited 22× · PMID 37301278 · DOI 10.1016/j.jmb.2023.168173
  8. Vaccine-induced spike- and nucleocapsid-specific cellular responses maintain potent cross-reactivity to SARS-CoV-2 Delta and Omicron variants.
    Chiuppesi F, Zaia JA, Faircloth K, Johnson D, et al · · 2022 · cited 17× · PMID 35846380 · DOI 10.1016/j.isci.2022.104745

Verify or expand the search:

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Trials by the same sponsor.

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