A Phase 2 interventional study of High-dose inactivated influenza vaccine and Standard-dose inactivated influenza vaccine in Hematologic Malignancy and Influenza, sponsored by Sung-Han Kim. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Sung-Han Kim · Phase 2, Interventional, and Prevention
This randomized trial will compare the immune responses to high-dose and standard-dose influenza vaccines in 60 adults with blood cancers (hematologic malignancies) who have received B-cell-depleting therapy. Participants will be assigned by chance, in a 1:1 ratio, to receive one of the two vaccines. Antibody and T-cell responses will be measured before and after vaccination. Participants and their treating clinicians will know which vaccine is given. Laboratory staff who measure and interpret the immune responses will not know which vaccine each participant received until the laboratory results are finalized.
This single-center, randomized, parallel-group trial with blinded laboratory outcome assessment will compare the immunogenicity of high-dose and standard-dose inactivated influenza vaccines in adults with hematologic malignancies who have received B-cell-depleting therapy as defined in the protocol. A total of 60 participants will be randomized in a 1:1 ratio at Asan Medical Center in Seoul, Republic of Korea.
Humoral immunogenicity will be assessed using hemagglutination inhibition assays. Cellular immunogenicity will be assessed using intracellular cytokine staining of influenza OLP-stimulated peripheral blood mononuclear cells to quantify cytokine-expressing CD4-positive and CD8-positive T cells, including polyfunctional cells that co-express at least two of IFN-γ, TNF-α, and IL-2.
Participants, treating clinicians, and personnel administering the vaccines will know the vaccine assignment. Laboratory personnel performing and interpreting the immunogenicity assays will receive coded specimens and remain blinded to vaccine assignment until assay measurements, gating, quality control, and laboratory results are finalized. Statistical analysts will not be blinded to treatment allocation. Blinding applies to laboratory immunogenicity outcomes only.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Sung-Han Kim is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a single intramuscular dose of high-dose trivalent inactivated influenza vaccine (Efluelda), containing 60 micrograms of hemagglutinin per strain, on Day 0.
Biological: High-dose inactivated influenza vaccine
Participants receive a single intramuscular dose of standard-dose trivalent inactivated influenza vaccine, containing 15 micrograms of hemagglutinin per strain, on Day 0.
Biological: Standard-dose inactivated influenza vaccine
Trivalent inactivated influenza vaccine containing 60 micrograms of hemagglutinin per strain, administered as a single intramuscular injection on Day 0. It contains four times the hemagglutinin antigen per strain of the standard-dose vaccine.
Also known as: Efluelda
Trivalent inactivated influenza vaccine containing 15 micrograms of hemagglutinin per strain, administered as a single intramuscular injection on Day 0. It is the comparator for the high-dose vaccine.
Seroconversion Rate at Day 28 After Influenza Vaccination
Percentage of participants with seroconversion, measured by hemagglutination inhibition (HAI) assay and defined in the study protocol. Seroconversion is analyzed as seroconversion to at least one vaccine strain (each participant counted once) and separately for each vaccine strain.
Time frame: Day 28 (±7 days) after vaccination
Geometric Mean Fold Rise of Hemagglutination Inhibition Titer
Geometric mean of the within-participant ratio of post-vaccination to baseline HAI titer, reported for each vaccine strain.
Time frame: Day 28 (±7 days), Day 180 (±30 days), and Day 365 (±30 days) after vaccination
Proportion of Participants With Hemagglutination Inhibition Titer of at Least 1:40
Percentage of participants with an HAI titer of 1:40 or greater, reported for each vaccine strain.
Time frame: Day 28 (±7 days), Day 180 (±30 days), and Day 365 (±30 days) after vaccination
Frequency of Polyfunctional Influenza-Specific CD4-Positive and CD8-Positive T Cells
Percentage of CD4-positive and CD8-positive T cells co-expressing at least two of IFN-gamma, TNF-alpha, and IL-2 after stimulation with influenza hemagglutinin overlapping peptide pools, measured by intracellular cytokine staining
Time frame: Baseline and Day 28 (±7 days) after vaccination
Plan to share: Undecided — Individual participant data are not planned to be shared at this time because of participant privacy and confidentiality considerations. The principal investigator will consider data sharing after registration and will update this statement before the results are published.
Started Nov 2026 (actual). Primary completion is estimated for Dec 2027, 13 months after the start.
Of 114 non-industry phase 2 interventional studies under Hematologic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 95. This study's planned 13 months is below that.
Counting every sponsor, half of 136 studies reached it within 57 months; a quarter within 40 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sung-Han Kim