Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590808
• Other study ID #: 1806-088-951
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 30, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Solid Carcinoma

Intervention

Biological:
• Influenza vaccination
Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. Erratum in: JAMA Oncol. 2016 Jan;2(1):146. — View Citation

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. — View Citation

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. Erratum in: MMWR Recomm Rep. 2010 Aug 13;59(31):993. MMWR Recomm Rep. 2010 Sep 10;59(35):1147. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seroconversion rate	Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre	21 to 35 days after vaccination
Secondary	Geometric mean titer of HI	Geometric mean titers of HI (haemagglutination inhibition) after vaccination	21 to 35 days after vaccination
Secondary	Injection-related adverse events	The proportion of patients who experienced local or systemic adverse events related to vaccination	21 to 35 days after vaccination
Secondary	Immune-related adverse events	The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events	6 months after vaccination
Secondary	T-cell mediated immune response	The levels of intracellular cytokines measured by flow cytometry	21 to 35 days after vaccination