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Chronic Lymphocytic LeukemiaPhase 2NCT05672355

A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Biospecimen Collection, mRNA COVID-19 Vaccine and Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 in people with Chronic Lymphocytic Leukemia and COVID-19 Infection, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, mRNA COVID-19 Vaccine and Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 7 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Age: >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) =< 1
  • Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification
  • Prior COVID-19 Vaccination (2 or more Pfizer or Moderna) with last injection >= 3 months prior
  • Fully recovered from the acute toxic effects (except alopecia) to =< Grade 1 to prior anti-cancer therapy
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  • White Blood Cells (WBC) >= 1,000/mm^3 (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Platelets >= 50,000/mm^3 (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Aspartate aminotransferase (AST) =< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Alanine transaminase (ALT) =< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Creatinine clearance <1.5 ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 14 days prior to Day 1 of protocol therapy)
  • If the urine test is positive or cannot be confirmed as negative, 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 vaccine injection
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Known current SARS CoV-2 infection
  • Prior Evusheld or other anti-SARS CoV-2 prophylaxis < 2 weeks prior
  • Prior hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T cell therapy within the previous year
  • Systemic corticosteroids required for chronic conditions at doses > 0.5mg/kg/day prednisone equivalent within 7 days of enrollment
  • Intensive cytotoxic therapies, T-cell depleting therapies, within 30 days of enrollment; however, patients with stable disease on maintenance therapies are allowed (See ConMeds for lists of acceptable and contraindicated therapies)
  • Participants who have had a live vaccine =< 30 days prior to administration of any dose 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 a study vaccine injection and > 2 weeks post study vaccine injection
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (e.g., egg allergies)
  • Active infection not controlled on appropriate therapy
  • History of adverse event with a prior smallpox vaccination
  • History of pericarditis or myocarditis
  • Any MVA vaccine or poxvirus vaccine in the last 12 months
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient'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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Randomized Observer-Blinded Phase 2 Trial of COVID-19 Booster With GEO-CM04S1 or mRNA Vaccine in Patients With Chronic Lymphocytic Leukemia

This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Estimate the T cell-based immune response rate on day 56 post-injection of synthetic MVA-based SARS-CoV-2 vaccine COH04S1 (GEO-CM04S1) vaccine boost administered at 2.5x10^8 plaque-forming unit (PFU) or standard of care (SOC) vaccine administered as standard of care.

SECONDARY OBJECTIVES:

  1. Evaluate the safety of single-dose vaccine boost based on moderate and unacceptable toxicities up to day 28 post-injection for the GEO-CM04S1 and SOC vaccines.

II. Estimate the T cell-based immune response rate at day 112 post-injection of GEO-CM04S1 vaccine at 2.5x10^8 PFU vs SOC severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine administered as COVID-19 vaccine boosters.

III. Select the more promising vaccine to study further as a booster in patients with CLL.

IV. Evaluate SARS-CoV-2 S and N-specific Th1 vs Th2 polarization. V. Estimate the magnitude and durability of T-cell-based immune responses over a 12-month period.

VI. Estimate the levels and durability of SARS-CoV-2-specific IgG in a 12-month period.

VII. Evaluate levels of antibodies neutralizing SARS-CoV-2 in original strain and in variants of concern (VOC) based on the Centers for Disease Control and Prevention (CDC) definition using Spike-pseudotyped lentivirus.

VIII. Evaluate the overall safety profile during follow-up (12 months). IX. Estimate the incidence and severity of COVID-19 infection during follow-up (12 months).

EXPLORATORY OBJECTIVES:

  1. Determine the SARS-CoV-2 variant by sequencing virus from polymerase chain reaction (PCR)-confirmed infected participants.

II. Evaluate activated/cycling and memory phenotype markers in SARS-CoV-2 stimulated T cells.

III. Estimate SARS-CoV-2-specfic serum IgA levels measured by enzyme-linked immunoassay (ELISA).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive GEO-CM04S1 vaccine intramuscularly (IM) on days 0 and 84 on study.

ARM II. Patients receive mRNA vaccine injection IM on days 0 and 84 on study.

Patients undergo blood sample collections throughout the study and are monitored for 1 year.

Being tested
Biospecimen Collection, mRNA COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • mRNA COVID-19 VaccineBiological

    Also called COVID-19 mRNA Vaccine, mRNA-based COVID-19 Vaccine, SARS-CoV-2 mRNA Vaccine

    Given IM

  • Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1Biological

    Also called COH04S1, SARS-CoV-2 Vaccine COH04S1, sMVA-based SARS-CoV-2 Vaccine COH04S1

    Given IM

Study groups in NCT05672355
Study groupRoleWhat they receive
Arm I (GEO-CM04S1)ExperimentalPatients receive GEO-CM04S1 vaccine IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.
Receives: Procedure: Biospecimen Collection; Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Arm II (mRNA Covid-19 Vaccine)Active comparatorPatients receive mRNA vaccine injection IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.
Receives: Procedure: Biospecimen Collection; Biological: mRNA COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T cell response

    Assessed by >= 3-fold increase in S-specific or N-specific IFN-gamma-secreting T cells over baseline at day 56 (Primary Immune Analysis [PIA]), using Enzyme-linked Immunosorbent Spot (ELISPOT) assay to quantify SARS CoV-2 reactive T cells.

    • Note: Missing immune response will not be imputed. Missing immune response will be categorized as no for intent-to-treat analysis but will be excluded in per-protocol analysis.

    Measured: Baseline to day 56

Secondary outcomes (11)

  1. Incidence of adverse events (AEs) moderate toxicity (MOD)

    Grade 2 AEs (based on Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) probably or definitely attributable to vaccine boost, lasting >= 7 days. The primary toxicity analysis will be summarized in terms of type, severity, time of onset, duration, probable association with GEO-CM04S1 vaccine and reversibility or outcome.

    Measured: From each injection to Day 28 post injection

  2. Incidence of AEs unacceptable toxicity (UT)

    Grade 3-5 AEs (based on CTCAE version 5.0) probably or definitely attributable to vaccine boost. The primary toxicity analysis will be summarized in terms of type, severity, time of onset, duration, probable association with GEO-CM04S1 vaccine and reversibility or outcome.

    Measured: From each injection to Day 28 post injection

  3. Incidence of myocarditis or pericarditis

    Any grade probably or definitely attributable to vaccine boost.

    Measured: Up to 42 days following final injection of study vaccine (GEO-CM04S1 or standard of care [SoC] mRNA-CoV-2 vaccine)

  4. Incidence of serious adverse events (SAEs)

    At least possibly related to vaccine booster injection, with the exception of hospitalization for grades 1 or 2 fever.

    Measured: From each injection to Day 365 post injection

  5. T cell response

    As assessed by >= 3-fold increase in S-specific or N-specific IFN-gamma-secreting T cells, using ELISPOT assay to quantify SARS CoV-2 reactive T cells. Scatterplots of immune response markers across time points will be generated to visualize the temporal patterns.

    Measured: Baseline to 28 days after the second booster injection

  6. T cell fold-increase

    ELISPOT assay of SARS CoV-2 reactive T cell cytokines (IFN-gamma, IL-4).

    Measured: At all immune test time points (Baseline, and days 28, 56, 84, 112, 180 and 365)

  7. SARS-CoV-2-S and -N specific IFNgamma (Th1) and IL-4 (Th2) cytokine levels following stimulation with overlapping peptide libraries specific for SARS-CoV-2

    The immune response rate at day 112 and 90% CI will be calculated by arm. Continuous immune response markers will be summarized by means or geometric means and standard deviations if the assumption of normal distribution is not violated. Repeated immune response measurements at the multiple time points will be analyzed using generalized estimating equations (GEE) or mixed regression models. Scatterplots of immune response markers across time points will be generated to visualize the temporal patterns.

    Measured: Up to 2 years

  8. Level of antibodies neutralizing SARS-CoV-2 Spike pseudoviruses

    Based on ancestral Wuhan strain and SARS-CoV-2 variants of concern (VOC) or variants of high consequence (VHC) based on Centers for Disease Control and Prevention (CDC) definition.

    Measured: At day 56 after the first booster injection (PIA), at 28 days after the second booster injection (day 112), and at days 180 and 365

  9. Levels of S- or N-specific IgG titers

    Using quantitative enxyme-linked immunoassay (ELISA) based on World Health Organization (WHO) international standard for SARS-CoV-2 antibodies.

    Measured: At day 56 after the first booster injection (PIA), 28 days after the second booster injection (day 112), and at days 180 and 365

  10. Confirmed COVID-19 infection by PCR viral load

    Measured: Baseline to 1 year

  11. Severe COVID-19 infection by Food and Drug Administration (FDA) criteria

    Measured: Baseline up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start1 Aug 2023
  3. Primary completion29 Jun 2026
  4. Study completion7 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672355
Sponsor's protocol ID
22416
Other IDs
NCI-2022-10303, 22416, P30CA033572
Status last verified
Sep 2026
First submitted
3 Jan 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, mRNA COVID-19 Vaccine and Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 in people with Chronic Lymphocytic Leukemia and COVID-19 Infection, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T cell response (time frame: Baseline to day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672355.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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