A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy : A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy

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 tumorTo 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 tumorSecondary:-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 proteinsTo evaluate salivary measurement of IgGEligibility: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 yearsECOG performance status <2Participants must have adequate organ and bone marrow functionParticipants 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 excludedParticipants who have had prior administration of an investigational coronavirus (e.g. SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine are excludedParticipants with known hypotension, uncontrolled chronic pulmonary or cardiovascular disease are excludedParticipants with a history of anaphylaxis, urticaria, or other significant adverse reaction after receipt of vaccine are excludedDesignThis 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)..

Media Type:

Clinical Trial

Year of Publication:

2021

Publication:

2021

Contained In:

ClinicalTrials.gov - (2021) vom: 04. Mai To Main Record - year:2021

Language:

English

Links:

Volltext [Kostenfrei]

Keywords:

Hematologic Neoplasms
Multiple Myeloma
Neoplasms

NCTID:

04847050

Study Publications:

PPN (Catalogue-ID):

CTG003743179