Influenza Vaccination Strategies in Patients with Hematologic Cancer.
Victoria G Hall, Olivia C Smibert, Sheena G Sullivan...
https://pubmed.ncbi.nlm.nih.gov/39813653Actively Recruiting
Phase 3
Age: 19Years +
All Genders
ID07485855
Comparison of Immunogenicity of High-Dose, Adjuvanted, and Standard Influenza Vaccines in Patients With Hematologic Malignancies
Led by Asan Medical Center · Updated on 2026-03-24
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare the immune response generated by three different influenza vaccines in patients with blood cancers, including those undergoing autologous stem cell transplantation or CAR-T cell therapy. Patients with hematologic malignancies have a much higher risk of influenza infection and severe complications due to their weakened immune systems from disease and treatment. The study focuses on identifying which vaccine formulation produces the strongest antibody and T cell responses, important for protection in this vulnerable group. The trial compares three vaccines: a high-dose trivalent inactivated influenza vaccine (HD-IIV3), an MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4), and a standard-dose trivalent inactivated influenza vaccine (SD-IIV3). Each vaccine is given as a single intramuscular injection during the flu season. Participants are randomly assigned to receive one of these vaccines to assess differences in immune responses. Participants will be monitored at baseline and followed up on Days 28, 180, and 365 after vaccination. The study will measure antibody levels and T cell activity using blood tests to evaluate immune response. The main outcome is the rate of seroconversion at Day 28 post-vaccination. Safety and immune response will be closely observed throughout the study, which continues until April 2028.
CONDITIONS
Brief Title
Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Confirmed diagnosis of hematologic malignancy, including non-Hodgkin lymphoma, Hodgkin lymphoma, acute leukemia, chronic leukemia, or plasma cell disorders
You will not qualify if you...
- Difficulty with repeated venipuncture or blood sampling such as poor vascular access or bleeding tendency
- Cognitive or psychiatric impairment that prevents understanding or cooperating with study procedures
- Known allergy to influenza vaccine components
- Influenza vaccination within the past 6 months
- Any condition considered clinically inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day
Participants receive a single intramuscular injection of one of three influenza vaccines: high-dose trivalent, MF59-adjuvanted quadrivalent, or standard-dose trivalent during the influenza season.
1 vaccination visit (in-person)
Monitoring
Duration - Up to 1 year
Participants undergo immunogenicity assessments including antibody and cellular immune responses at multiple time points after vaccination.
Visits at Day 28, Day 180, and Day 365 post-vaccination (in-person)
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
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Research Team
S
So Yun Lim, MD, PhD
S
Sung-Han Kim, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/41166714Influenza-Specific T-Cell Responses to Vaccination Are Independent of Underlying Hematological Malignancy: Analysis of a Randomized Influenza Vaccination Trial.
Victoria G Hall, Thi H O Nguyen, Olivia C Smibert...
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Hannah Kinoshita, Carla S Walti, Kathleen Webber...
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Andrew R Branagan, Eamon Duffy, Geliang Gan...
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Y Natori, A Humar, J Lipton...
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Natasha B Halasa, Bipin N Savani, Ishan Asokan...
https://pubmed.ncbi.nlm.nih.gov/26705931Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients.
Lora D Thomas, Einas Batarseh, Lubna Hamdan...
https://pubmed.ncbi.nlm.nih.gov/39219510The humoral immune response to high-dose influenza vaccine in persons with monoclonal B-cell lymphocytosis (MBL) and chronic lymphocytic leukemia (CLL).
Jennifer A Whitaker, Sameer A Parikh, Tait D Shanafelt...
https://pubmed.ncbi.nlm.nih.gov/33461835A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation.
Benjamin W Teh, Vivian K Y Leung, Francesca L Mordant...
https://pubmed.ncbi.nlm.nih.gov/33175132