NCT04847050View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 28, 2021

Primary Completion Date

May 25, 2023

Study Completion Date

May 25, 2023

Conditions
Solid Tumor MalignancyHematologic MalignancyLeukemiaLymphomaMultiple Myeloma
Interventions
BIOLOGICAL

Messenger ribonucleic acid (mRNA)-1273 Vaccine

A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered intramuscular (IM) on Day 1 and 29 for vaccine naive cohorts.

BIOLOGICAL

Messenger ribonucleic acid (mRNA)-1273 Vaccine Booster

A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered intramuscular (IM) on Day 1 for vaccine booster cohorts. Participants may receive up to 3 booster injections on study.

DIAGNOSTIC_TEST

ECG

Baseline (-28 days/Day 1); and Day 29 (+/- 3 days).

OTHER

Antibiotics

Use of prophylactic antibiotics is recommended according to institutional standards.

OTHER

Anti-viral agents

Use of prophylactic antiviral agents is recommended according to institutional standards.

OTHER

Anti-fungal agent

Use of prophylactic antifungal agents is recommended according to institutional standards.

OTHER

Anti-emetics

Use of prophylactic anti-emetics is recommended according to institutional standards.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH