Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
2020년 4월 20일 업데이트: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
A Cohort Study to Evaluate the Impact of Inactivated Trivalent Influenza Vaccine on the Immunogenicity, Safety and Survival of Non-small Cell Lung Cancer Patients Receiving PD-1 / PD-L1 Inhibitors
This project is to assess the immunogenicity, safety and overall survival impact of intramuscular injection of trivalent influenza vaccine in non-small cell lung cancer (NSCLC) patients with PD-1/PD-L1 inhibitor treatment.
연구 개요
상태
아직 모집하지 않음
상세 설명
Lung cancer is one of the most prevalent cancers in the world. Among them, non-small cell lung cancer (NSCLC) accounts for about 85%. Immune checkpoint inhibitors such as programmed death 1(PD-1) and PD-L1 are new treatments for NSCLC. About 290,000 to 650,000 people die from respiratory illnesses caused by seasonal flu all over the world. Cancer patients are one of the high-risk groups of influenza. Although the United States, Britain, Australia have issued guidelines recommending that cancer patients be vaccinated against influenza every year, due to concerns about the immune effect and safety of flu vaccination for cancer patients, multiple countries including China have not included cancer patients into priority influenza vaccination populations. Therefore, how to further prove the immunogenicity and safety of influenza vaccine in NSCLC patients is the key to promote influenza vaccines in NSCLC patients.
This study will recruit 130 patients with NSCLC who have been treated with PD-1 / PD-L1 inhibitors for 6 months or more and 30 healthy participants. Among them, 100 NSCLC patients and 30 healthy participants will be intramuscularly inactivated with a trivalent influenza vaccine during the influenza seasons 2020-21 and 2021-22. Vaccinated participants' peripheral blood samples were collected at day0, 12 hours, day1, 2, 7, 21, 30, 60 and 6 months after vaccination. The influenza specific antibody titers, inflammatory chemokines and cytokines, antibody-dependent cellular cytotoxicity (ADCC) activity, T lymphocytes activity and the proportions of different T cells subgroups will be measured to evaluate the participants' immune response to the vaccine. In addition, for the subjects receiving the vaccine, the study will also group by age to compare the differences in immune effects between subjects aged 18-65 and subjects over 65.
At last, this project will compare immune-related adverse events (irAEs) that occurred after receiving PD-1 / PD-L1 inhibitor therapy and survival time between NSCLC patients who receive influenza vaccine and those who do not receive influenza vaccine.
연구 유형
관찰
등록 (예상)
160
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yayi He
- 전화번호: 8613818828623
- 이메일: 2250601@qq.com
연구 장소
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Hong Kong
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Hong Kong, Hong Kong, 중국
- School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong
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연락하다:
- Lit Man Leo Poon, PhD.
- 전화번호: 852-3917 9943
- 이메일: llmpoon@hkucc.hku.hk
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Shanghai
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Shanghai, Shanghai, 중국, 200433
- Shanghai Pulmonary Hospital
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연락하다:
- Yayi He
- 전화번호: 8613818828623
- 이메일: 2250601@qq.com
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수석 연구원:
- Yayi He, PhD, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
NSCLC patients receiving PD-1/PD-L1 inhibitors during this project
설명
Inclusion Criteria:
- NSCLC patients were diagnosed with clear pathological classification and receive PD-1 / PD-L1 inhibitor treatment during this project.
- NSCLC patients have the exact start and end time of PD-1 / PD-L1 inhibitor and / or the vaccination time and follow-up information.
- The healthy participants are not in an immunosuppressive state, such as cancer, HIV, autoimmune diseases, and long-term use of immunosuppressive drugs.
- The healthy participants have exact vaccination time.
- All participants have complete clinical and laboratory diagnostic data.
- All participants are 18-75 years, regardless of gender.
- All participants have agreed and signed the consent form before enrollment.
Exclusion Criteria:
- Patients with unclear diagnosis of lung cancer were excluded.
- Patients with incomplete clinical data or incomplete follow-up records.
- Patients without signed informed consent.
- Patient has received blood transfusion within three months.
- Patients with HIV, Hepatitis B and Hepatitis C infections.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Vaccinated NSCLC group
This group contains 100 NSCLC patients receiving PD-1/PD-L1 inhibitors for more than 6 months, who will be intramuscularly injected one dose of inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
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Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
다른 이름들:
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
다른 이름들:
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Vaccinated Health group
This group contains 30 healthy participants without immunosuppressive diseases, who will be intramuscularly injected one dose of inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
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Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
다른 이름들:
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Unvaccinated NSCLC group
This group contains 30 NSCLC patients receiving PD-1/PD-L1 inhibitors for more than 6 months without intramuscular injection of any inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
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Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
기간: Day 0 after vaccination
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The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
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Day 0 after vaccination
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Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
기간: Day 2 after vaccination
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The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
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Day 2 after vaccination
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Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
기간: Day 7 after vaccination
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The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
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Day 7 after vaccination
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Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
기간: Day 21 after vaccination
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The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
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Day 21 after vaccination
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Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
기간: Day 30 after vaccination
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The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
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Day 30 after vaccination
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Titer of neutralization antibody
기간: Day 0 after vaccination
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Titer of neutralization antibody is measured by neutralization test.
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Day 0 after vaccination
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Titer of neutralization antibody
기간: Day 21 after vaccination
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Titer of neutralization antibody is measured by neutralization test.
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Day 21 after vaccination
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Titer of neutralization antibody
기간: Day 30 after vaccination
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Titer of neutralization antibody is measured by neutralization test.
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Day 30 after vaccination
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Titer of neutralization antibody
기간: Day 60 after vaccination
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Titer of neutralization antibody is measured by neutralization test.
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Day 60 after vaccination
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Titer of neutralization antibody
기간: Month 6 after vaccination
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Titer of neutralization antibody is measured by neutralization test.
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Month 6 after vaccination
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Multiple chemokine and cytokine levels in peripheral blood
기간: Day 0 after vaccination
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IFN-γ, IL-1β, IL-2,IL-3,IL-4,IL-5,IL-6,IL-8 (CXCL8),IL-9,IL-10,IL-11,IL-12,IL-13,GM-CSF,TNF-α, IP-10 (CXCL10), MCP-1 (CCL2), and TARC (CCL17) in peripheral blood are measured by cytometry bead assay.
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Day 0 after vaccination
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Multiple chemokine and cytokine levels in peripheral blood
기간: 12 hours after vaccination
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IFN-γ, IL-1β, IL-2,IL-3,IL-4,IL-5,IL-6,IL-8 (CXCL8),IL-9,IL-10,IL-11,IL-12,IL-13,GM-CSF,TNF-α, IP-10 (CXCL10), MCP-1 (CCL2), and TARC (CCL17) in peripheral blood are measured by cytometry bead assay.
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12 hours after vaccination
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Multiple chemokine and cytokine levels in peripheral blood
기간: Day 1 after vaccination
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IFN-γ, IL-1β, IL-2,IL-3,IL-4,IL-5,IL-6,IL-8 (CXCL8),IL-9,IL-10,IL-11,IL-12,IL-13,GM-CSF,TNF-α, IP-10 (CXCL10), MCP-1 (CCL2), and TARC (CCL17) in peripheral blood are measured by cytometry bead assay.
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Day 1 after vaccination
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Multiple chemokine and cytokine levels in peripheral blood
기간: Day 2 after vaccination
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IFN-γ, IL-1β, IL-2,IL-3,IL-4,IL-5,IL-6,IL-8 (CXCL8),IL-9,IL-10,IL-11,IL-12,IL-13,GM-CSF,TNF-α, IP-10 (CXCL10), MCP-1 (CCL2), and TARC (CCL17) in peripheral blood are measured by cytometry bead assay.
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Day 2 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 0 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Day 0 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: 12 hours after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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12 hours after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 1 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Day 1 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 2 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Day 2 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 7 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Day 7 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 21 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Day 21 after vaccination
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 30 after vaccination
|
The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
|
Day 30 after vaccination
|
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Day 60 after vaccination
|
The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
|
Day 60 after vaccination
|
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The numbers and proportions of T lymphocyte subpopulations in peripheral blood
기간: Month 6 after vaccination
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The numbers and proportions of CD4+ T cells, CD8+ T cells, naïve T cells and effector memory T cells in peripheral blood are measured by multiple flow cytometry.
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Month 6 after vaccination
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Peripheral T cell activation and proliferation
기간: Day 0 after vaccination
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The CD3, CD4, CD8 and CD69 expressions and cell count of peripheral T cells are measured by multiple flow cytometry upon carboxyfluorescein succinimidyl amino ester (CFSE) labeling and anti-CD3/28 beads activation.
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Day 0 after vaccination
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Peripheral T cell activation and proliferation
기간: Day 30 after vaccination
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The CD3, CD4, CD8 and CD69 expressions and cell count of peripheral T cells are measured by multiple flow cytometry upon carboxyfluorescein succinimidyl amino ester (CFSE) labeling and anti-CD3/28 beads activation.
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Day 30 after vaccination
|
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Peripheral T cell activation and proliferation
기간: Day 60 after vaccination
|
The CD3, CD4, CD8 and CD69 expressions and cell count of peripheral T cells are measured by multiple flow cytometry upon carboxyfluorescein succinimidyl amino ester (CFSE) labeling and anti-CD3/28 beads activation.
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Day 60 after vaccination
|
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Peripheral T cell activation and proliferation
기간: Month 6 after vaccination
|
The CD3, CD4, CD8 and CD69 expressions and cell count of peripheral T cells are measured by multiple flow cytometry upon carboxyfluorescein succinimidyl amino ester (CFSE) labeling and anti-CD3/28 beads activation.
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Month 6 after vaccination
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Antibody-dependent cellular cytotoxicity (ADCC)
기간: Day 0 after vaccination
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The ADCC activities of NK-92 cells cultured by the sera from vaccinated participants are measured by lactic acid dehydrogenase (LDH) release of A549 cells infected by H1N1 and H3N2.
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Day 0 after vaccination
|
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Antibody-dependent cellular cytotoxicity (ADCC)
기간: Day 30 after vaccination
|
The ADCC activities of NK-92 cells cultured by the sera collected from vaccinated participants are measured by lactic acid dehydrogenase (LDH) release of A549 cells infected by H1N1 and H3N2.
|
Day 30 after vaccination
|
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Antibody-dependent cellular cytotoxicity (ADCC)
기간: Day 60 after vaccination
|
The ADCC activities of NK-92 cells cultured by the sera collected from vaccinated participants are measured by lactic acid dehydrogenase (LDH) release of A549 cells infected by H1N1 and H3N2.
|
Day 60 after vaccination
|
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Antibody-dependent cellular cytotoxicity (ADCC)
기간: Month 6 after vaccination
|
The ADCC activities of NK-92 cells cultured by the sera collected from vaccinated participants are measured by lactic acid dehydrogenase (LDH) release of A549 cells infected by H1N1 and H3N2.
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Month 6 after vaccination
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Immune-related adverse events (irAEs)
기간: June 2020- June 2023
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The performances and the grades of irAEs according to Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0) and their correlation with vaccination.
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June 2020- June 2023
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Progression-free Survival (PFS)
기간: June 2020- June 2023 (3 year)
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PFS is calculated as the time from from PD-1/PD-L1 inhibitor starting to the disease progression or the death from any cause.
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June 2020- June 2023 (3 year)
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Overall Survival (OS)
기간: June 2020- June 2023 (3 year)
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OS is calculated as the time from PD-1/PD-L1 inhibitor starting to the death from any cause.
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June 2020- June 2023 (3 year)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR)
기간: June 2020- June 2023 (3 year)
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The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete response (CR) and partial response (PR) according to Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1).
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June 2020- June 2023 (3 year)
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Disease Control Rate (DCR)
기간: June 2020- June 2023 (3 year)
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The proportion of patients achieve CR or PR or stable disease (SD) after PD-1/PD-L1 inhibitor treatment according to RECIST 1.1.
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June 2020- June 2023 (3 year)
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Time to Treatment Failure (TFF)
기간: June 2020- June 2023 (3 year)
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The time from the start of PD-1/PD-L1 inhibitor to the withdrawal of the trial.
The reasons for withdrawal include the patient's voluntary withdrawal, disease progression, adverse events and even deaths.
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June 2020- June 2023 (3 year)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yayi He, PhD, MD, Shanghai Pulmonary Hospital, Shanghai, China
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2020년 6월 1일
기본 완료 (예상)
2022년 12월 31일
연구 완료 (예상)
2023년 5월 31일
연구 등록 날짜
최초 제출
2020년 4월 9일
QC 기준을 충족하는 최초 제출
2020년 4월 20일
처음 게시됨 (실제)
2020년 4월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 20일
마지막으로 확인됨
2020년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TIV-NSCLC-PD1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .