Multiple Myeloma Clinical Trial
SARS-CoV-2 Vaccine (COH04S1) Versus EUA SARS-COV-2 Vaccine for the Treatment of COVID-19 in Patients With Blood Cancer
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.
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.
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.
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.
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)
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
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There is 1 Location for this study
Duarte California, 91010, United States More Info
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