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

Summary

Background:

Coronavirus disease (COVID-19) is a viral infection. It has spread rapidly across the globe. It has overwhelmed health systems. Researchers are concerned that it may undo years of progress in the reduction of cancer-specific death. They want to test a vaccine that might protect people with cancer from COVID-19.

Objective:

To test the safety and efficacy of a vaccine using messenger ribonucleic acid (mRNA)-1273 that may protect people with cancer from COVID-19.

Eligibility:

Adults ages 18 and older who have a solid tumor or blood cancer and who may benefit from a vaccine that might prepare their immune system for fighting and preventing infection from COVID-19. Patients with solid tumors must be receiving treatment with an immunotherapy agent.

Design:

Participants will be screened with a medical history, medicine review, and physical exam. They will have blood tests. They will have a pregnancy test if needed.

Participants will get 2 doses of the mRNA-1273 vaccine if they have not been vaccinated already. It will be injected into a muscle in the arm on Days 1 and 29. They will be followed for 12 months after the second dose.

Participants will have study visits at the Clinical Center on Days 1, 29, 36,57, 209, and 394. Some visits will last about 4-6 hours. Patients will be able to get up to 3 doses of mRNA-1273 as a booster on trial if they have already completed a primary series of a vaccine. Participants who have already received a booster dose of vaccine will be able to enroll to receive additional boosters. It will be injected into a muscle in the arm on Day 1. Participants will be followed for 12 months after their last booster injection. Participants who receive booster doses will have study visits at the Clinical Center on Days 1, 29, 57, 180 and 360.

Participants will give blood and saliva samples for research.

Participation will last about 16 months.

Conditions

• Solid Tumor Malignancy
• Hematologic Malignancy
• Leukemia
• Lymphoma
• Multiple 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• James Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-28

Primary Completion

2023-05-25

Completion

2023-05-25

FDA Drug

Yes

Countries

• United States

Study Locations