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

NCT ID: NCT04355806

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-05-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

PD-1/PD-L1 inhibitors

Intervention Type: DRUG

Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.

Inactivated trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.

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).

Inactivated trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.

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).

PD-1/PD-L1 inhibitors

Intervention Type: DRUG

Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.

Interventions

PD-1/PD-L1 inhibitors

Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.

Intervention Type: DRUG

Inactivated trivalent influenza vaccine

Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.

Intervention Type: BIOLOGICAL

Other Intervention Names

PD-1/PD-L1 blockades; PD-1 monoclonal antibodies; PD-L1 monoclonal antibodies; Flu Vaccines; Influenza Virus Vaccines; Influenza Vaccine, Trivalent; Vaccine, Trivalent Influenza; Flu Shot

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yayi He, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

School of Public Health, Li Ka Shing Faculty of Medicine, University of Hong Kong

Hong Kong, Hong Kong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Yayi He

Role: CONTACT

2250601@qq.com

8613818828623

Facility Contacts

Lit Man Leo Poon, PhD.

Role: primary

llmpoon@hkucc.hku.hk

852-3917 9943

Yayi He

Role: primary

2250601@qq.com

8613818828623

Other Identifiers

TIV-NSCLC-PD1

Identifier Type: -

Identifier Source: org_study_id