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
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|ClinicalTrials.gov Identifier: NCT04847050|
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : June 10, 2021
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. The COVID-19 Vaccine from Moderna has obtained an emergency use authorization from the FDA. The vaccine has been proven to reduce infections with the virus that causes COVID-19, and it has already been given to millions of people around the world.
To test the safety and efficacy of a vaccine using mRNA-1273 that may protect people with cancer from COVID-19.
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
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. It will be injected into a muscle in the arm on Days 1 and 29. Participants will have a follow-up phone call on Day 8 after the first dose. They will be followed for 12 months after the second dose.
Participants will have study visits at the Clinical Center on Days 1 and 29 to get the COVID-19 vaccine from Moderna. Patients will then be asked to come back for visits about 1 week and 1 month after the second dose. Patients will need to come back for visits 6 months and 1 year after the second vaccine dose to check to see how long the vaccine offers protection.
Some visits will last up to a few hours, but most will be significantly shorter.
Participants will give blood and saliva samples for research.
Participation will last about 13 months.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Malignancy Hematologic Malignancy Leukemia Lymphoma Multiple Myeloma||Biological: mRNA-1273||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 28, 2021|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||February 25, 2023|
100 microgram (0.5 mL) mRNA-1273 injection on D1 and 29
A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered IM on Day 1 and 29
- Assess immunogenicity of m-RNA 1273 administered in 2 doses [ Time Frame: 14 months ]- 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 tumor- Titer or level of SARS-CoV- 2-specific binding antibody (bAb) measured by ELISA on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.
- Safety and reactogenicity of MRNA-1273 vaccine [ Time Frame: 14 months ]- Solicited local and systemic Adverse Reactions (ARs) through 7 days after each injection.- Unsolicited AEs through 28 days after each injection.- SAEs throughout the entire study period.- Safety laboratory abnormalities at Day 29 and Day 57.- Vital sign measurements and physical examination findings.
- immunogenicity of mrna-1273 vaccine as assessed by neutralizing antibody (nAb) [ Time Frame: 14 months ]-Titer or level of SARS-CoV-2-specific neutralizing antibody (nAb) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.-Seroconversion due to vaccination on Day 29, Day 36, Day 57, Day 209, and Day 394 as measured by an increase of SARS-CoV-2-specific nAb titer or level defined as-For subjects with no detectable antibody titer (<LOD) at baseline: post-vaccinationtiter >= LLOQ-For subjects with a positive baseline titer (> LOD): post-vaccinationtiter >= 4 times the LLOQ-For subjects with a baseline titer >= LLOQ: post-vaccinationtiter >= a 4-fold rise compared with baseline titer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847050
|Contact: Marissa B Mallek, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Elad Sharon, M.D.||National Cancer Institute (NCI)|