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

20 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

160

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yayi He
  • Numero di telefono: 8613818828623
  • Email: 2250601@qq.com

Luoghi di studio

  • Cina
    • Hong Kong
      • Hong Kong, Hong Kong, Cina
        • School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong
        • Contatto:
    • Shanghai
      • Shanghai, Shanghai, Cina, 200433
        • Shanghai Pulmonary Hospital
        • Contatto:
        • Investigatore principale:
          • Yayi He, PhD, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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).
Droga: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Altri nomi:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies
Biologico: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Altri nomi:
  • 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).
Biologico: Inactivated trivalent influenza vaccine
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
Altri nomi:
  • 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).
Droga: PD-1/PD-L1 inhibitors
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Altri nomi:
  • PD-1/PD-L1 blockades
  • PD-1 monoclonal antibodies
  • PD-L1 monoclonal antibodies

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Day 0 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 0 after vaccination
Titer of neutralization antibody
Lasso di tempo: Day 21 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 21 after vaccination
Titer of neutralization antibody
Lasso di tempo: Day 30 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 30 after vaccination
Titer of neutralization antibody
Lasso di tempo: Day 60 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Day 60 after vaccination
Titer of neutralization antibody
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaboratori

The University of Hong Kong

Investigatori

  • Investigatore principale: Yayi He, PhD, MD, Shanghai Pulmonary Hospital, Shanghai, China

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 giugno 2020

Completamento primario (Anticipato)

31 dicembre 2022

Completamento dello studio (Anticipato)

31 maggio 2023

Date di iscrizione allo studio

Primo inviato

9 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

20 aprile 2020

Primo Inserito (Effettivo)

21 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TIV-NSCLC-PD1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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