A 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/Actively Recruiting
Led by Asan Medical Center · Updated on 2026-07-28
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the immune responses generated by three different influenza vaccines in patients with hematologic malignancies, including those undergoing autologous stem cell transplantation or CAR-T cell therapy. This study aims to identify which vaccine formulation produces the strongest antibody and T cell immune responses in this highly immunocompromised group, as prior trials have not fully assessed T cell protection especially in B cell-depleted patients. The trial compares 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 influenza season. Participants are randomly assigned to one of these three vaccine groups to assess differences in immunogenicity. Participants will be monitored through blood samples and immune testing at baseline, Day 28, Day 180, and Day 365 after vaccination. Researchers will measure antibody responses such as seroconversion rates and geometric mean titers, as well as cellular immune responses involving CD4 and CD8 T cells. The study will track safety and immune markers over a full year to understand the vaccines longer-term effects in this vulnerable population.
CONDITIONS
Influenza Vaccination Strategy for Patients With Hematologic Malignancy
S
So Yun Lim, MD, PhD
S
Sung-Han Kim, MD, PhD
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Asan Medical Center
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit during influenza season
Participants receive a single intramuscular injection of one of three influenza vaccines during the influenza season.
1 visit (in-person)
Duration - 1 year after vaccination
Participants undergo blood tests and immune response assessments at baseline, Day 28, Day 180, and Day 365 after vaccination to measure antibody and T cell responses.
4 visits (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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Lead Sponsor