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, Including Boost... : 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, Including Booster Doses of Vaccine

Design of the Study:This is an open-label, multicenter clinical trial designed to evaluate the safety, reactogenicity and primary immunogenicity of the mRNA-1273 vaccine administered in 2 doses, 28 days apart, in participants who have 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 can be associated with appropriately high rates of development of neutralizing antibodies of mRNA-1273. The trial will also evaluate the safety, reactogenicity and immunogenicity after administration of additional booster doses of the vaccine.Study Phase:<TAB>2Study Population:<TAB>For the vaccine-na(SqrRoot) ve cohorts, up to 80 participants will be enrolled.20 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.60 participants with leukemia, lymphoma, multiple myeloma and participants post-allogeneic stem cell transplant will be enrolled based on their perceived risk of immunosuppression.For the previously-vaccinated (also known as "booster") cohorts, up to 140 participants will be enrolled for booster injections. All participants on the vaccine-na(SqrRoot) ve cohorts will have the option of receiving boosters; however, they will not count towards the maximum accrual goal for each of the booster groups. Note: All participants will be eligible to receive up to three (3) booster doses of vaccine on study.20 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.20 participants with chronic lymphocytic leukemia who are not currently on any therapies20 participants with chronic lymphocytic leukemia who are on BTK inhibitor therapy alone30 participants with any CAR T Cell therapy for a hematologic malignancy20 participants post-allogeneic stem cell transplant20 participants with other hematologic malignanciesUp to 10 participants with any solid tumor who are not otherwise eligible for any of the other cohortsNumber of Sites: 2Description of Study Product or Intervention:mRNA-1273 Injection (Drug Product) is an LNP dispersion containing a single mRNA sequence (Drug Substance) that encodes the SARS-CoV-2 S glycoprotein stabilized in the prefusion conformation. The mRNA-1273 Drug Substance is combined with a mixture of 4 lipids common to the Moderna s mRNA vaccine platform: SM-102 (a custom-manufactured, ionizable lipid) and 3 commercially available lipids, cholesterol, DSPC, and PEG2000-DMG (https://doi.org/10.1038/s41587-020- 00807-1). mRNA-1273 Injection is provided as a sterile solution for injection, white to off white dispersion in appearance.Presentation: mRNA-1273 Injection is provided as a sterile solution for injection at a concentration of 0.2 mg/mL in 20 mM trometamol (Tris) buffer containing 87 mg/mL sucrose and 4.3 mM acetate, at pH 7.5. mRNA-1273 Injection is presented in 10R USP Type I borosilicate glass vials with PLASCAP vial seal containing a 20 mm FluroTec-coated plug stopper and has a 6.3 mL nominal fill volume. This vial may be used for more than one participant.mRNA-1273 Injection must be stored frozen at -15 degrees C to -25 degrees C until thawed for use and then stored refrigerated at 2 degrees C to 8 degrees C for up to 30 days (once thawed it must not be refrozen)Each dose of 100 mcg (0.5 mL) will be administered via IM injection into the deltoid muscle on Days 1 and 29 (+/- 3 days) for the vaccine-na(SqrRoot) ve cohorts. Up to 3 additional ( booster ) doses of the vaccine may also be administered.Study 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 for patients who are vaccine-na(SqrRoot) veTo evaluate the safety and reactogenicity of booster doses of mRNA-1273 vaccine administered to participants who have previously received an mRNA or alternative vaccine regimenTo evaluate the safety and reactogenicity of booster doses of mRNA-1273 administered to participants with CLL who are either off treatment or are engaging in a 3-week BTK inhibitor interruption to enhance vaccine immunogenicityTo assess the immunogenicity of mRNA-1273 in participants with cancer, as assessed by the titer or level of specific binding antibody (bAb)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) in the vaccine-na(SqrRoot) ve cohortsTo evaluate the immunogenicity of booster doses of mRNA-1273 vaccine administered to participants who have previously been vaccinated against SARS-CoV2 with any prior vaccine regimen. 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 IgG antibodies against the SARS-CoV-2 nucleocapsid and spike (S) proteinsDuration of Individual Participant Participation:The duration for each individual participation is approximately 14 months (from first contact to last visit).Study Duration:Study duration is anticipated to be 16 months (from start of screening to last Participant/last visit)..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 02. Juni Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Hematologic Neoplasms Multiple Myeloma Neoplasms Phase: Phase 2 Recruitment Status: Completed Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: April 15, 2021, Last downloaded: ClinicalTrials.gov processed this data on June 07, 2023, Last updated: June 07, 2023

Study ID:	NCT04847050 10000115 000115-C
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG003743179