To hear about similar clinical trials, please enter your email below
Trial Title:
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
NCT ID:
NCT05672355
Condition:
Chronic Lymphocytic Leukemia
COVID-19 Infection
Conditions: Official terms:
COVID-19
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Vaccines
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
This trial is observer-blinded because the physical appearance of GEO-CM04S1 and mRNA
vaccine may vary. The investigators, treating clinicians, participants, and other study
staff, including the nurses involved in soliciting or recording of AEs, will be blinded
through the day 112 visit.
The study statisticians, pharmacists, and nurses who administer the vaccine injections
will be unblinded. To avoid inadvertent unblinding of the participants at the time of
injection, the syringe will be obscured from view by the nurse during injection.
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (GEO-CM04S1)
Arm group label:
Arm II (mRNA Covid-19 Vaccine)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Biological
Intervention name:
mRNA COVID-19 Vaccine
Description:
Given IM
Arm group label:
Arm II (mRNA Covid-19 Vaccine)
Other name:
COVID-19 mRNA Vaccine
Other name:
mRNA-based COVID-19 Vaccine
Other name:
SARS-CoV-2 mRNA Vaccine
Intervention type:
Biological
Intervention name:
Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Description:
Given IM
Arm group label:
Arm I (GEO-CM04S1)
Other name:
COH04S1
Other name:
SARS-CoV-2 Vaccine COH04S1
Other name:
sMVA-based SARS-CoV-2 Vaccine COH04S1
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). 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.
Detailed description:
PRIMARY OBJECTIVE:
I. 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:
I. 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:
I. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexey V. Danilov
Phone:
626-218-2405
Email:
adanilov@coh.org
Investigator:
Last name:
Alexey V. Danilov
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
January 12, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672355