Non Small Cell Lung CancerNCT04355806
Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
An observational study of Non Small Cell Lung Cancer and Influenza Vaccine, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer, Influenza Vaccine
- What is being tested?
- PD-1/PD-L1 inhibitors and Inactivated trivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2020to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NSCLC patients receiving PD-1/PD-L1 inhibitors during this project
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong
Hong Kong, Hong Kong
Lit Man Leo Poon, PhD., 852-3917 9943, llmpoon@hkucc.hku.hk
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Yayi He, 8613818828623, 2250601@qq.com
Yayi He, PhD, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Non Small Cell Lung Cancer, Influenza Vaccine
- Being tested
- PD-1/PD-L1 inhibitors, Inactivated trivalent influenza vaccine
- Keywords
- Non-Small Cell Lung Cancer, Influenza Vaccine, PD-1 Receptor, Programmed Cell Death 1 Ligand 1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1/PD-L1 inhibitorsDrug
Also called PD-1/PD-L1 blockades, PD-1 monoclonal antibodies, PD-L1 monoclonal antibodies
Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
Inactivated trivalent influenza vaccineBiological
Also called Flu Vaccines, Influenza Virus Vaccines, Influenza Vaccine, Trivalent, Vaccine, Trivalent Influenza
Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: PD-1/PD-L1 inhibitors; Biological: Inactivated trivalent influenza vaccine | |
| 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). Receives: Biological: Inactivated trivalent influenza vaccine | |
| 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). Receives: Drug: PD-1/PD-L1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Measured: Day 0 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Measured: Day 2 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Measured: Day 7 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Measured: Day 21 after vaccination
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
The titers of anti-HA IgG and IgM antibodies ,and anti-NP IgG and IgM antibodies are measured by enzyme linked immunosorbent assay (ELISA).
Measured: Day 30 after vaccination
Titer of neutralization antibody
Titer of neutralization antibody is measured by neutralization test.
Measured: Day 0 after vaccination
Titer of neutralization antibody
Titer of neutralization antibody is measured by neutralization test.
Measured: Day 21 after vaccination
Titer of neutralization antibody
Titer of neutralization antibody is measured by neutralization test.
Measured: Day 30 after vaccination
Titer of neutralization antibody
Titer of neutralization antibody is measured by neutralization test.
Measured: Day 60 after vaccination
Titer of neutralization antibody
Titer of neutralization antibody is measured by neutralization test.
Measured: Month 6 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
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.
Measured: Day 0 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
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.
Measured: 12 hours after vaccination
Multiple chemokine and cytokine levels in peripheral blood
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.
Measured: Day 1 after vaccination
Multiple chemokine and cytokine levels in peripheral blood
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.
Measured: Day 2 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 0 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: 12 hours after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 1 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 2 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 7 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 21 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 30 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Day 60 after vaccination
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
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.
Measured: Month 6 after vaccination
Peripheral T cell activation and proliferation
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.
Measured: Day 0 after vaccination
Peripheral T cell activation and proliferation
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.
Measured: Day 30 after vaccination
Peripheral T cell activation and proliferation
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.
Measured: Day 60 after vaccination
Peripheral T cell activation and proliferation
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.
Measured: Month 6 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
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.
Measured: Day 0 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
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.
Measured: Day 30 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
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.
Measured: Day 60 after vaccination
Antibody-dependent cellular cytotoxicity (ADCC)
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.
Measured: Month 6 after vaccination
Immune-related adverse events (irAEs)
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.
Measured: June 2020- June 2023
Progression-free Survival (PFS)
PFS is calculated as the time from from PD-1/PD-L1 inhibitor starting to the disease progression or the death from any cause.
Measured: June 2020- June 2023 (3 year)
Overall Survival (OS)
OS is calculated as the time from PD-1/PD-L1 inhibitor starting to the death from any cause.
Measured: June 2020- June 2023 (3 year)
Secondary outcomes (3)
Objective Response Rate (ORR)
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).
Measured: June 2020- June 2023 (3 year)
Disease Control Rate (DCR)
The proportion of patients achieve CR or PR or stable disease (SD) after PD-1/PD-L1 inhibitor treatment according to RECIST 1.1.
Measured: June 2020- June 2023 (3 year)
Time to Treatment Failure (TFF)
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.
Measured: June 2020- June 2023 (3 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Yayi He, PhD, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355806
- Sponsor's protocol ID
- TIV-NSCLC-PD1
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04355806
- Acronym / sponsor ID
- TIV-NSCLC-PD1
- Conditions
- Non Small Cell Lung Cancer, Influenza Vaccine
- Keywords
- Non-Small Cell Lung Cancer, Influenza Vaccine, PD-1 Receptor, Programmed Cell Death 1 Ligand 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccinated NSCLC group | – | Drug: PD-1/PD-L1 inhibitors, Biological: Inactivated trivalent influenza vaccineThis 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). |
| Vaccinated Health group | – | Biological: Inactivated trivalent influenza vaccineThis 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). |
| Unvaccinated NSCLC group | – | Drug: PD-1/PD-L1 inhibitorsThis 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients receiving PD-1/PD-L1 inhibitors during this project
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1/PD-L1 inhibitorsAlso: PD-1/PD-L1 blockades, PD-1 monoclonal antibodies, PD-L1 monoclonal antibodiesIncluding nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al. | Drug | Unvaccinated NSCLC group, Vaccinated NSCLC group |
| Inactivated trivalent influenza vaccineAlso: Flu Vaccines, Influenza Virus Vaccines, Influenza Vaccine, Trivalent, Vaccine, Trivalent InfluenzaIncluding two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane. | Biological | Vaccinated Health group, Vaccinated NSCLC group |
Primary outcome
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Time frame: 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).
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Time frame: 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).
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Time frame: 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).
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Time frame: 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).
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM)
Time frame: 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).
Titer of neutralization antibody
Time frame: Day 0 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Titer of neutralization antibody
Time frame: Day 21 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Titer of neutralization antibody
Time frame: Day 30 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Titer of neutralization antibody
Time frame: Day 60 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Titer of neutralization antibody
Time frame: Month 6 after vaccination
Titer of neutralization antibody is measured by neutralization test.
Multiple chemokine and cytokine levels in peripheral blood
Time frame: 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.
Multiple chemokine and cytokine levels in peripheral blood
Time frame: 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.
Multiple chemokine and cytokine levels in peripheral blood
Time frame: 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.
Multiple chemokine and cytokine levels in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
The numbers and proportions of T lymphocyte subpopulations in peripheral blood
Time frame: 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.
Peripheral T cell activation and proliferation
Time frame: 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.
Peripheral T cell activation and proliferation
Time frame: 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.
Peripheral T cell activation and proliferation
Time frame: 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.
Peripheral T cell activation and proliferation
Time frame: 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.
Antibody-dependent cellular cytotoxicity (ADCC)
Time frame: 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.
Antibody-dependent cellular cytotoxicity (ADCC)
Time frame: 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.
Antibody-dependent cellular cytotoxicity (ADCC)
Time frame: 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.
Antibody-dependent cellular cytotoxicity (ADCC)
Time frame: 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.
Immune-related adverse events (irAEs)
Time frame: 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.
Progression-free Survival (PFS)
Time frame: 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.
Overall Survival (OS)
Time frame: 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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: June 2020- June 2023 (3 year)
Disease Control Rate (DCR)
Time frame: June 2020- June 2023 (3 year)
Time to Treatment Failure (TFF)
Time frame: June 2020- June 2023 (3 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yayi He, PhD, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Influenza Vaccine, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yayi He (8613818828623, 2250601@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titers of anti-nucleoprotein(NP) or anti-hemagglutinin(HA) antibody (IgG and IgM) (time frame: Day 0 after vaccination). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.