InfluenzaNCT03590808

Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

A study testing Influenza vaccination in people with Influenza and Solid Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 20 years and older
Conditions the study is for: Influenza, Solid Carcinoma
What is being tested?: Influenza vaccination
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 1 siteSouth Korea
Study dates: 1 Sep 2018to 30 May 2019
Phase: Interventional
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Influenza Vaccine in Cancer 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.

Read the detailed 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).

Conditions: Influenza, Solid Carcinoma
Being tested: Influenza vaccination
Keywords: Influenza, vaccine, solid carcinoma, immune checkpoint, efficacy, safety
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03590808
Study group	Role	What they receive
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 Receives: 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 Receives: Biological: Influenza vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroprotection rate
The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
Measured: 21 to 35 days after vaccination

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201830 May 2019

First posted18 Jul 2018
Study start1 Sep 2018
Primary completion21 Dec 2018
Study completion30 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Double center prospective case-control clinical trial
Masking: None (open label)
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03590808
Sponsor's protocol ID: 1806-088-951
Status last verified: Sep 2019
First submitted: 10 Jul 2018
Last updated: 19 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.

Publications

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.
PubMed 29320654
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.
PubMed 28596256
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.
PubMed 28404761
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.
PubMed 28596261
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.
PubMed 27997703
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.
PubMed 20689501
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.
PubMed 20385981
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.
PubMed 26270597
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.
PubMed 31680143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor
ClinicalTrials.gov ID: NCT03590808
Acronym / sponsor ID: 1806-088-951
Conditions: Influenza, Solid Carcinoma
Keywords: Influenza, vaccine, solid carcinoma, immune checkpoint, efficacy, safety
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Green Cross Corporation
Study start: 1 Sep 2018 (actual)
Primary completion: 21 Dec 2018 (actual)
Study completion: 30 May 2019 (actual)
First posted: 18 Jul 2018 (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.

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

Detailed 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).

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Double center prospective case-control clinical trial

Arm	Type	Receives
Immune checkpoint inhibitor	Experimental	Biological: Influenza vaccinationSolid 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
Cytotoxic chemotherapy	Active comparator	Biological: Influenza vaccinationSolid 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

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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

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
Influenza vaccinationPurified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM	Biological	Cytotoxic chemotherapy, Immune checkpoint inhibitor

Primary outcome

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)

5 secondary outcomes

Seroconversion rate
Time frame: 21 to 35 days after vaccination
Geometric mean titer of HI
Time frame: 21 to 35 days after vaccination
Injection-related adverse events
Time frame: 21 to 35 days after vaccination
Immune-related adverse events
Time frame: 6 months after vaccination
T-cell mediated immune response
Time frame: 21 to 35 days after vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
Background: PubMed 29320654Postow 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.
Background: PubMed 28596256Adelstein 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.
Background: PubMed 28404761Ettinger 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.
Background: PubMed 28596261Motzer 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.
Background: PubMed 27997703Keam 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.
Background: PubMed 20689501Fiore 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.
Background: PubMed 20385981Pollyea 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.
Background: PubMed 26270597Dueck 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.
Derived from this study: PubMed 31680143Keam 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.
Individual participant dataSharing planned: No. We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.

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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.

Wan Beom Park, M.D., PhD. principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Influenza vaccination in people with Influenza and Solid Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroprotection rate (time frame: 21 to 35 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03590808, which also lists 9 linked publications.

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 19 Sep 2019.