Phase 2
N=15
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
Solid Tumor Malignancy · Hematologic Malignancy · Leukemia · Lymphoma · Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT04847050 ↗Enrolled (actual)
15
Serious AEs
15.8%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase — 0; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Messenger ribonucleic acid (mRNA)-1273 Vaccine (Biological); Messenger ribonucleic acid (mRNA)-1273 Vaccine Booster (Biological); ECG (Diagnostic_test); Antibiotics (Other); Anti-viral agents (Other); Anti-fungal agent (Other); Anti-emetics (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase |
2; 2; 6; 3; 1; 2 | — |
| PRIMARY Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase |
0; 0; 1; 1; 0; 3 | — |
| PRIMARY Number of Participants Who Had Vital Signs Performed Prior to Vaccine |
2; 3; 7; 3; 4; 2 | — |
| PRIMARY Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase |
0; 0; 2.1; 0; 0.3; 0 | — |
| PRIMARY Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase |
2; 1; 7; 1; 1; 3 | — |
| SECONDARY Number of Neutralizing Antibody Samples - Initial Phase |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Neutralizing Antibody Samples - Booster Phase |
3; 1; 10; 3; 2; 12 | — |
| SECONDARY Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase |
4041.3; 23271.4; 4904.71; 30161.9; 43021.6; 22317.0 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
Participants must meet all the inclusion criteria in order to be eligible to participate in the study.
Participants must have one of the following:
- Histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (PD1)/Programmed death-ligand 1 (PDL1) inhibitor for treatment of their solid tumor (inclusive of Hodgkin Lymphoma and Primary Mediastinal B-Cell Lymphoma participants receiving PD1/PDL1 inhibitors as standard of care therapy)
- Confirmed diagnosis of acute leukemia (myeloid (AML) or lymphoid (ALL) or other acute leukemia; multiple myeloma; Waldenstrom macroglobulinemia
- Confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia)
- Be post allogeneic stem cell transplantation (for any indication)
- Be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories
- Age >=18 years.
- History of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below:
- Absolute lymphocyte count-Minimum value of 200 cells per mcL
- Absolute neutrophil count-Minimum value of 500 cells per mcL
- Platelets-Minimum value of 25, 000 cells per mcL
- Total bilirubin-Maximum value of 3.0 x upper limit of normal
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine transaminase ALT serum glutamic-pyruvic transaminase (SGPT)-Maximum value of 5.0 x upper limit of normal
- Creatinine-Maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below)
- Creatinine clearance (only necessary for participants with elevated creatinine)-For participants with Chronic Kidney Disease, a calculated
Glomerular Filtration Rate minimum will be required as follows: >30 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
- Participants with history of human immunodeficiency virus (HIV) may enroll
- Participants with history of chronic hepatitis B virus (HBV) must be on suppressive therapy (if indicated) with undetectable viral load.
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured with an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- A negative urine/serum pregnancy test for females of childbearing potential. The effects of mRNA-1273 Vaccine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment.
Note: A female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range).
Effective methods of contraception:
- Intrauterine device.
- Stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment.
- Hormonal contraceptive tablets.
- Injectable hormonal contraceptives.
- Implanted hormonal contraceptives.
- Cutaneous contraceptive patches.
- Intravaginal hormonal contraceptive rings.
At least 1 barrier method. Effective barrier methods for use in this study are:
- Male or female condom.
- Diaphragm.
- Creams or gels that contain a chemical to kill sperm
If a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception.
- Ability to understand and the willingness to sign a written informed consent document.
- CLL participants
Data sourced from ClinicalTrials.gov (NCT04847050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.