New vaccine aims to better protect blood cancer patients from COVID-19
NCT ID NCT04977024
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new COVID-19 vaccine (GEO-CM04S1) in 63 adults with blood cancers like leukemia or lymphoma who have had a stem cell transplant or cell therapy. The goal is to see if this vaccine triggers a stronger immune response than standard mRNA vaccines, potentially offering better protection against COVID-19. Participants receive two shots and are monitored for immune response and side effects.
Why investors are watching
GeoVax is testing its vaccine GEO-CM04S1 against standard mRNA COVID-19 vaccines in 63 blood cancer patients who had stem cell transplants or cellular therapy. This is a small company, so this phase 2 readout could define whether its vaccine has a meaningful edge in a vulnerable patient group where standard vaccines may work poorly.
If it works: If GEO-CM04S1 produces a stronger immune response or better protection than mRNA vaccines in these patients, GeoVax could gain a foothold in a niche market for immunocompromised people. That result might also support further development and partnerships.
If it fails: The trial could fail to show an advantage, or the company could face delays in enrollment or data. Most phase 2 trials do not lead to approved products, so a negative or unclear result would likely hurt the company's prospects.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
63 people
The number who actually took part.
- Started
-
Sep 2021
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for COVID-19 infection are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
-
City of Hope Medical Center
Duarte, California, 91010, United States
-
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
-
Johns Hopkins University
Baltimore, Maryland, 21205, United States
-
SUNY-Stony Brook
Stony Brook, New York, 11794, United States
-
U Mass Chan Medical School
Worcester, Massachusetts, 01655, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Double-Drug attack on Hard-to-Treat lymphomas
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children