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Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors

20. dubna 2020 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Očekávaný)

160

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yayi He
  • Telefonní číslo: 8613818828623
  • E-mail: 2250601@qq.com

Studijní místa

  • Čína
    • Hong Kong
      • Hong Kong, Hong Kong, Čína
        • School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong
        • Kontakt:
    • Shanghai
      • Shanghai, Shanghai, Čína, 200433
        • Shanghai Pulmonary Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Yayi He, PhD, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

NSCLC patients receiving PD-1/PD-L1 inhibitors during this project

Popis

Inclusion Criteria:

  1. NSCLC patients were diagnosed with clear pathological classification and receive PD-1 / PD-L1 inhibitor treatment during this project.
  2. NSCLC patients have the exact start and end time of PD-1 / PD-L1 inhibitor and / or the vaccination time and follow-up information.
  3. The healthy participants are not in an immunosuppressive state, such as cancer, HIV, autoimmune diseases, and long-term use of immunosuppressive drugs.
  4. The healthy participants have exact vaccination time.
  5. All participants have complete clinical and laboratory diagnostic data.
  6. All participants are 18-75 years, regardless of gender.
  7. All participants have agreed and signed the consent form before enrollment.

Exclusion Criteria:

  1. Patients with unclear diagnosis of lung cancer were excluded.
  2. Patients with incomplete clinical data or incomplete follow-up records.
  3. Patients without signed informed consent.
  4. Patient has received blood transfusion within three months.
  5. Patients with HIV, Hepatitis B and Hepatitis C infections.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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).
Lék: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Ostatní jména:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies
Biologický: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Ostatní jména:
  • Flu Vaccines
  • Influenza Virus Vaccines
  • Influenza Vaccine, Trivalent
  • Vaccine, Trivalent Influenza
  • Flu Shot
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).
Biologický: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Ostatní jména:
  • Flu Vaccines
  • Influenza Virus Vaccines
  • Influenza Vaccine, Trivalent
  • Vaccine, Trivalent Influenza
  • Flu Shot
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).
Lék: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Ostatní jména:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Časové okno: Day 0 after vaccination
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Day 0 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Časové okno: Day 2 after vaccination
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Day 2 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Časové okno: Day 7 after vaccination
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Day 7 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Časové okno: Day 21 after vaccination
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Day 21 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Časové okno: Day 30 after vaccination
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Day 30 after vaccination
Titer of neutralization antibody
Časové okno: Day 0 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 0 after vaccination
Titer of neutralization antibody
Časové okno: Day 21 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 21 after vaccination
Titer of neutralization antibody
Časové okno: Day 30 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 30 after vaccination
Titer of neutralization antibody
Časové okno: Day 60 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 60 after vaccination
Titer of neutralization antibody
Časové okno: Month 6 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Month 6 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
Časové okno: Day 0 after vaccination
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.
Day 0 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
Časové okno: 12 hours after vaccination
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.
12 hours after vaccination
Multiple chemokine and cytokine levels in peripheral blood
Časové okno: Day 1 after vaccination
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.
Day 1 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
Časové okno: Day 2 after vaccination
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.
Day 2 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Day 0 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 0 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: 12 hours 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.
12 hours after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Day 1 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 1 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Day 2 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 2 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Day 7 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 7 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Day 21 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 21 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: 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
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: 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
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Časové okno: Month 6 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.
Month 6 after vaccination
Peripheral T cell activation and proliferation
Časové okno: Day 0 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.
Day 0 after vaccination
Peripheral T cell activation and proliferation
Časové okno: Day 30 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.
Day 30 after vaccination
Peripheral T cell activation and proliferation
Časové okno: 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.
Day 60 after vaccination
Peripheral T cell activation and proliferation
Časové okno: 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.
Month 6 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
Časové okno: Day 0 after vaccination
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.
Day 0 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
Časové okno: 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
Antibody-dependent cellular cytotoxicity (ADCC)
Časové okno: 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
Antibody-dependent cellular cytotoxicity (ADCC)
Časové okno: 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.
Month 6 after vaccination
Immune-related adverse events (irAEs)
Časové okno: June 2020- June 2023
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.
June 2020- June 2023
Progression-free Survival (PFS)
Časové okno: June 2020- June 2023 (3 year)
PFS is calculated as the time from from PD-1/PD-L1 inhibitor starting to the disease progression or the death from any cause.
June 2020- June 2023 (3 year)
Overall Survival (OS)
Časové okno: June 2020- June 2023 (3 year)
OS is calculated as the time from PD-1/PD-L1 inhibitor starting to the death from any cause.
June 2020- June 2023 (3 year)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate (ORR)
Časové okno: June 2020- June 2023 (3 year)
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).
June 2020- June 2023 (3 year)
Disease Control Rate (DCR)
Časové okno: June 2020- June 2023 (3 year)
The proportion of patients achieve CR or PR or stable disease (SD) after PD-1/PD-L1 inhibitor treatment according to RECIST 1.1.
June 2020- June 2023 (3 year)
Time to Treatment Failure (TFF)
Časové okno: June 2020- June 2023 (3 year)
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.
June 2020- June 2023 (3 year)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Pulmonary Hospital, Shanghai, China

Spolupracovníci

The University of Hong Kong

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yayi He, PhD, MD, Shanghai Pulmonary Hospital, Shanghai, China

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. června 2020

Primární dokončení (Očekávaný)

31. prosince 2022

Dokončení studie (Očekávaný)

31. května 2023

Termíny zápisu do studia

První předloženo

9. dubna 2020

První předloženo, které splnilo kritéria kontroly kvality

20. dubna 2020

První zveřejněno (Aktuální)

21. dubna 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. dubna 2020

Naposledy ověřeno

1. dubna 2020

Více informací

Termíny související s touto studií

Klíčová slova

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Další identifikační čísla studie

  • TIV-NSCLC-PD1

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