Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

20 kwietnia 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Oczekiwany)

160

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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).
Lek: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Inne nazwy:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies
Biologiczny: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Inne nazwy:
  • 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).
Biologiczny: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Inne nazwy:
  • 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).
Lek: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Inne nazwy:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Day 0 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 0 after vaccination
Titer of neutralization antibody
Ramy czasowe: Day 21 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 21 after vaccination
Titer of neutralization antibody
Ramy czasowe: Day 30 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 30 after vaccination
Titer of neutralization antibody
Ramy czasowe: Day 60 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 60 after vaccination
Titer of neutralization antibody
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Objective Response Rate (ORR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Współpracownicy

The University of Hong Kong

Śledczy

  • Główny śledczy: Yayi He, PhD, MD, Shanghai Pulmonary Hospital, Shanghai, China

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 czerwca 2020

Zakończenie podstawowe (Oczekiwany)

31 grudnia 2022

Ukończenie studiów (Oczekiwany)

31 maja 2023

Daty rejestracji na studia

Pierwszy przesłany

9 kwietnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 kwietnia 2020

Pierwszy wysłany (Rzeczywisty)

21 kwietnia 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 kwietnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 kwietnia 2020

Ostatnia weryfikacja

1 kwietnia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TIV-NSCLC-PD1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Niezdecydowany

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj