Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

NCT03590808 | Completed

• 1 other identifier: 1806-088-951
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza; Solid Carcinoma

Keywords

Influenza; vaccine; solid carcinoma; immune checkpoint; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Seroprotection rate

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

  21 to 35 days after vaccination

Secondary Outcomes (5)

• Seroconversion rate

  21 to 35 days after vaccination

• Geometric mean titer of HI

  21 to 35 days after vaccination

• Injection-related adverse events

  21 to 35 days after vaccination

• Immune-related adverse events

  6 months after vaccination

• T-cell mediated immune response

  21 to 35 days after vaccination

Study Arms (2)

Immune checkpoint inhibitor

EXPERIMENTAL

Solid cancer patients who receiving immune checkpoint inhibitor patients will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once

Biological: Influenza vaccination

Cytotoxic chemotherapy

ACTIVE COMPARATOR

Solid cancer patients who receiving conventional cytotoxic chemotherapy will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once

Biological: Influenza vaccination

Interventions

Influenza vaccination BIOLOGICAL

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

Cytotoxic chemotherapy; Immune checkpoint inhibitor

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Green Cross Corporation: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (9)

• Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018 Jan 11;378(2):158-168. doi: 10.1056/NEJMra1703481. No abstract available.

  PMID: 29320654 BACKGROUND

• Adelstein D, Gillison ML, Pfister DG, Spencer S, Adkins D, Brizel DM, Burtness B, Busse PM, Caudell JJ, Cmelak AJ, Colevas AD, Eisele DW, Fenton M, Foote RL, Gilbert J, Haddad RI, Hicks WL, Hitchcock YJ, Jimeno A, Leizman D, Lydiatt WM, Maghami E, Mell LK, Mittal BB, Pinto HA, Ridge JA, Rocco J, Rodriguez CP, Shah JP, Weber RS, Witek M, Worden F, Yom SS, Zhen W, Burns JL, Darlow SD. NCCN Guidelines Insights: Head and Neck Cancers, Version 2.2017. J Natl Compr Canc Netw. 2017 Jun;15(6):761-770. doi: 10.6004/jnccn.2017.0101.

  PMID: 28596256 BACKGROUND

• Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman J, Chirieac LR, D'Amico TA, DeCamp MM, Dilling TJ, Dobelbower M, Doebele RC, Govindan R, Gubens MA, Hennon M, Horn L, Komaki R, Lackner RP, Lanuti M, Leal TA, Leisch LJ, Lilenbaum R, Lin J, Loo BW Jr, Martins R, Otterson GA, Reckamp K, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer K, Yang SC, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Apr;15(4):504-535. doi: 10.6004/jnccn.2017.0050.

  PMID: 28404761 BACKGROUND

• Motzer RJ, Jonasch E, Agarwal N, Bhayani S, Bro WP, Chang SS, Choueiri TK, Costello BA, Derweesh IH, Fishman M, Gallagher TH, Gore JL, Hancock SL, Harrison MR, Kim W, Kyriakopoulos C, LaGrange C, Lam ET, Lau C, Michaelson MD, Olencki T, Pierorazio PM, Plimack ER, Redman BG, Shuch B, Somer B, Sonpavde G, Sosman J, Dwyer M, Kumar R. Kidney Cancer, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Jun;15(6):804-834. doi: 10.6004/jnccn.2017.0100.

  PMID: 28596261 BACKGROUND

• Keam B, Kim MK, Choi Y, Choi SJ, Choe PG, Lee KH, Kim TM, Kim TY, Oh DY, Kim DW, Im SA, Kim NJ, Heo DS, Park WB, Oh MD. Optimal timing of influenza vaccination during 3-week cytotoxic chemotherapy cycles. Cancer. 2017 Mar 1;123(5):841-848. doi: 10.1002/cncr.30468. Epub 2016 Dec 20.

  PMID: 27997703 BACKGROUND

• Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, Iskander JK, Wortley PM, Shay DK, Bresee JS, Cox NJ; Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep. 2010 Aug 6;59(RR-8):1-62.

  PMID: 20689501 BACKGROUND

• Pollyea DA, Brown JM, Horning SJ. Utility of influenza vaccination for oncology patients. J Clin Oncol. 2010 May 10;28(14):2481-90. doi: 10.1200/JCO.2009.26.6908. Epub 2010 Apr 12.

  PMID: 20385981 BACKGROUND

• Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015 Nov;1(8):1051-9. doi: 10.1001/jamaoncol.2015.2639.

  PMID: 26270597 BACKGROUND

• Keam B, Kang CK, Jun KI, Moon SM, Suh KJ, Lee DW, Ock CY, Kim M, Choi Y, Lim Y, Lee KH, Kim SH, Kim TM, Kim TY, Oh DY, Kim DW, Im SA, Lee JS, Kim ES, Kim HB, Kim NJ, Kim YJ, Park WB, Oh MD. Immunogenicity of Influenza Vaccination in Patients with Cancer Receiving Immune Checkpoint Inhibitors. Clin Infect Dis. 2020 Jul 11;71(2):422-425. doi: 10.1093/cid/ciz1092.

  PMID: 31680143 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Wan Beom Park, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double center prospective case-control clinical trial

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 18, 2018
• Study Start: September 1, 2018
• Primary Completion: December 21, 2018
• Study Completion: May 30, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)