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New vaccine aims to better protect blood cancer patients from COVID-19

NCT ID NCT04977024

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.