This phase II trial studies the immune response to COH04S1 compared to Emergency Use Authorization (EUA) SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. COH04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. COH04S1 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 COH04S1 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 EUA SARS-CoV-2 vaccine.
PRIMARY OBJECTIVE:
I. Evaluate the biological activity and the role of timing of 2 injections of COH04S1 vaccine
administered at 2.5x10e8 PFU/dose compared to EUA vaccine.
SECONDARY OBJECTIVES:
I. Assess safety of COH04S1 vaccine. II. Evaluation of SARS-CoV-2 S and N-specific Th1 vs Th2
polarization. III. Evaluate T-cell levels and function. IV. Evaluate activated/cycling and
memory phenotype markers. V. Evaluate durability of immune responses. VI. Evaluate
maintenance of immunity that can be associated with protection over the study period.
EXPLORATORY OBJECTIVE:
I. Surveillance for incidental COVID-19 infection during follow-up (1 year).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I : Patients receive one dose of COH04S1 intramuscularly (IM) in the upper arm on days 0
and 28.
ARM II : Patients receive one dose of EUA SARS-CoV-2 vaccine IM in the upper arm on days 0
and 28.
After the completion of study treatment, patients are followed up at days 7, 90, 120, 180,
and 365.
Biological: COVID-19 Vaccine
Receive EUA SARS-CoV-2 vaccine IM
Other: Diagnostic Laboratory Biomarker Analysis
Correlative studies
Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1
Given IM
Other Name: Array
Inclusion Criteria:
- Documented informed consent of the participant
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) =< 2
- 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)
- 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:
- Patients who have received second allogeneic HCT are not eligible (patients who have
undergone a previous autologous HCT are eligible
- Systemic corticosteroids required for chronic conditions at doses > 0.5mg/kg/day
prednisone equivalent
- Patients on maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors,
Janus kinase inhibitors), who may have significantly attenuated response to
vaccination
- Subjects using investigational or licensed agents that may prevent or treat SARS-CoV-2
are excluded such as any previous SARS-CoV-2 vaccine
- Subjects who have had 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
- 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
City of Hope Medical Center
Duarte, California, United States
Investigator: Sanjeet S. Dadwal
Contact: 626-218-8202
sdadwal@coh.org
Investigator: Sanjeet S. Dadwal
Chief Medical Officer
678-384-7220
info@geovax.com
Director Clinical Operations
Chief Medical Officer, Principal Investigator
GeoVax, Inc.