Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hematologic Malignancy
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Solid Tumor Malignancy
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background: Cancer patients are at increased risk from COVID-19 infection fatality due to underlying malignancy, treatment-related immunosuppression, or increased number of comorbidities. In solid tumor patients, treatment with immune checkpoint inhibitor has been considered a potential predictor fo...

Background: Cancer patients are at increased risk from COVID-19 infection fatality due to underlying malignancy, treatment-related immunosuppression, or increased number of comorbidities. In solid tumor patients, treatment with immune checkpoint inhibitor has been considered a potential predictor for severe disease. Similarly, patients with hematologic malignancies (acute leukemia, lymphoma, stem cell transplant) are the most immunosuppressed among all cancer patients and are known to have an increased risk for complications associated other respiratory viral infections. ModernaTX, Inc. is using its mRNA-based technology to develop a novel lipid nanoparticle (LNP)-encapsulated messenger RNA (mRNA)-based vaccine against SARS-CoV-2 (mRNA-1273). Preliminary clinical data from 1273 phase I study indicates that all 45 patients tested at doses 25, 100 and 200 mcg demonstrated antibodies after one dose and that 8 volunteers had neutralizing antibody. Recently reported data shows that mRNA-1273 induces both potent neutralizing antibody and CD8 T cell responses and protects against SARS-CoV-2 infection in lungs and noses of mice without evidence of immunopathology. Objectives: Primary: To evaluate the safety and reactogenicity of the mRNA-1273 vaccine administered in 2 doses, 28 days apart, in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment, or receiving a PD-1/PDL-1 inhibitor for treatment of a solid tumor To assess the immunogenicity of COVID-19 vaccine, mRNA-1273, administered in 2 doses 28 days apart, as assessed by the titer or level of specific binding antibody (bAb), in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment, or receiving a PD-1/PDL-1 inhibitor for treatment of a solid tumor Secondary: -To evaluate the immunogenicity of the mRNA-1273 vaccine administered in 2 doses 28 days apart, as assessed by the titer or level of neutralizing antibody (nAb) Exploratory: To assess immune responses against the SARS-CoV-2 nucleocapsid and spike proteins To evaluate salivary measurement of IgG Eligibility: Participants must have histologically or cytologically confirmed solid tumor; or confirmed diagnosis of acute leukemia (myeloid (AML) or lymphoid (ALL); multiple myeloma; or lymphoma, or post allogeneic stem cell transplantation (for any indication) Age >18 years ECOG performance status <2 Participants must have adequate organ and bone marrow function Participants with known history of SARS-CoV-2 infection or within 14 days of known exposure to someone with known SARS CoV2 infection COVD-19 are excluded Participants who have had prior administration of an investigational coronavirus (e.g. SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine are excluded Participants with known hypotension, uncontrolled chronic pulmonary or cardiovascular disease are excluded Participants with a history of anaphylaxis, urticaria, or other significant adverse reaction after receipt of vaccine are excluded Design This is an open-label, multicenter, phase II, clinical trial. Up to 120 subjects will be enrolled. For this trial, on the solid tumor cohort, we plan to enroll 60 participants with solid tumor malignancies who have initiated PD1/PDL1 inhibitor therapy as part of standard of care and are deemed to have a stable regimen without the need for any immunosuppressive therapy or corticosteroids (beyond physiologic dosing, if needed). For this trial, on the hematologic malignancy cohort, we plan to enroll 60 participants with leukemia, lymphoma, multiple myeloma and patients post-allogeneic stem cell transplant. Participants will be enrolled based on their perceived risk of immunosuppression. Subjects will receive an IM injection (0.5 mL) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). The duration of the entire study is anticipated to be 16 months (from start of screening to last subject last visit).

Tracking Information

NCT #
NCT04847050
Collaborators
Not Provided
Investigators
Principal Investigator: Elad Sharon, M.D. National Cancer Institute (NCI)