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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase
研究概览
简要总结
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.
详细描述
Design of the Study:
This is an open-label, multicenter clinical trial designed to evaluate the safety, reactogenicity and primary immunogenicity of the messenger ribonucleic acid (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 Programmed cell death protein 1 (PD-1)/Programmed death-ligand 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:
Study Population:
For the vaccine-na(SqrRoot) ve cohorts, up to 80 participants will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase
时间窗: End of 15-minute observation period following each vaccination on Day 1 and Day 29
Reactogenicity of mRNA-1273 vaccine was assessed by physical examination findings following vaccination. A physical exam will be performed to assess general physical condition in the following areas: supraclavicular and axillary lymph nodes, cardiovascular, pulmonary, abdomen and skin and include an assessment of pain, tenderness, erythema, induration and warmth at the injection site, fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, and abdominal pain following vaccination.
Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase
时间窗: End of 15-minute observation period following each vaccination on Day 1 and Day 29
Reactogenicity of mRNA-1273 of a booster vaccination was assessed by physical examination findings following vaccination. A physical exam will be performed to assess general physical condition in the following areas: supraclavicular and axillary lymph nodes, cardiovascular, pulmonary, abdomen and skin and include an assessment of pain, tenderness, erythema, induration and warmth at the injection site, fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, and abdominal pain following vaccination.
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase
时间窗: 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months
Solicited (expected) local and systemic Adverse Reactions (ARs) through 7 days after each injection were assessed using the clinical abnormalities section of the Food and Drug Administration (FDA) -Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Unsolicited (unexpected) adverse events (AEs) through 28 days after each injection and serious adverse events (SAE's) throughout the entire study period were assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Number of Participants Who Had Vital Signs Performed Prior to Vaccine
时间窗: Prior to each vaccine. Screening or Day 0 visit; Day 1, visit 1, vaccine dose 1; Day 29, visit 2, vaccine dose 2; Day 209 (6 months), visit 5 (+/- 28 days); and Day 394, visit 6 (+/- 28 days)
Vital signs: weight, temperature, heart rate/pulse, respirations, and blood pressure will be performed prior to each vaccine.
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase
时间窗: 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months
Solicited (expected) local and systemic Adverse Reactions (ARs) through 7 days after each injection were assessed using the clinical abnormalities section of the Food and Drug Administration (FDA) -Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Unsolicited (unexpected) adverse events (AEs) through 28 days after each injection and serious adverse events (SAE's) throughout the entire study period were assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase
时间窗: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Immunogenicity of mRNA 1273 administered in 2 doses was assessed by 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 programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor - Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.
次要结局
- Number of Neutralizing Antibody Samples - Initial Phase(For Vaccine Naive Arm: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394)
- Number of Neutralizing Antibody Samples - Booster Phase(Day 1, Day 29, Day 57, Day 180, and Day 360)
- Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase(Day 1, Day 29, Day 57, Day 180, and Day 360)
研究者
James Gulley, M.D.
Principal Investigator
National Cancer Institute (NCI)