Skip to main content
OpenTrials
Completed

NCT Number: NCT03590808

Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapy will be recruited 1:2 manner in two hospitals. Target numbers are 48 and 95, respectively.
  • All the participants will be vaccinated for influenza during their chemotherapy when they meet inclusion criteria.
  • All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination.
  • Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-35 days after vaccination) will be examined in all participants to examine seroprotection rates, seroconversion rates, and changes in geometric mean titer.
  • And they will be monitored for any vaccination-related adverse reaction or immune-related adverse events after 2-4 days(via phone call), and till 6 months after vaccination (when they visit oncology clinics).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapeutic agent in Seoul National University Hospital or Seoul National University Bundang Hospital.
  • Patients who was not vaccinated for influenza in 2018-2019 season
  • ECOG performance status 0 or 1
  • Patients who fulfilling following laboratory criteria Total bilirubin ≤ 1.5 x upper normal limit Aspartate transaminase, alanine transaminase ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit Creatinine ≤ upper normal limit
  • Patients who can understand and agreed with the informed consents.

Exclusion criteria

  • Patients having contraindication for influenza vaccination (e.g. egg allergy)
  • Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
  • Patients with HIV infection
  • Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
  • Patients who have transplanted organ and receive immunosuppressants
  • Patients who are suspected to have active infection (e.g. pneumonia)
  • Patients who receive targeted chemotherapeutic agent alone for cancer treatment
  • Patients who could not receive cancer chemotherapy due to hematologic abnormality at the date of the participation

Treatment and study plan

Influenza vaccination

Biological

Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM

Primary outcomes

  1. Seroprotection rate

    Time frame: 21 to 35 days after vaccination

    The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

Secondary outcomes

  1. Seroconversion rate

    Time frame: 21 to 35 days after vaccination

    Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre

  2. Geometric mean titer of HI

    Time frame: 21 to 35 days after vaccination

    Geometric mean titers of HI (haemagglutination inhibition) after vaccination

  3. Injection-related adverse events

    Time frame: 21 to 35 days after vaccination

    The proportion of patients who experienced local or systemic adverse events related to vaccination

  4. Immune-related adverse events

    Time frame: 6 months after vaccination

    The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events

  5. T-cell mediated immune response

    Time frame: 21 to 35 days after vaccination

    The levels of intracellular cytokines measured by flow cytometry

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Green Cross Corporation

Registry information

Official study title

Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.