Flu vaccine strategies for adults with blood cancers
Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies
PHASE3 · Asan Medical Center · NCT07485855
This study will test three different flu vaccines to see which gives the strongest antibody and T-cell responses in adults with blood cancers, including people after autologous stem cell transplant or CAR-T therapy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07485855 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled Phase 3 trial will assign adults with hematologic malignancies to receive one of three licensed influenza vaccines: high-dose trivalent (Efluelda), MF59-adjuvanted quadrivalent (Fluad Quadrivalent), or standard-dose trivalent. Immunogenicity will be compared using hemagglutination-inhibition antibody measures (GMT, seroconversion, seroprotection) and cellular assays quantifying polyfunctional CD4+ and CD8+ T-cell responses. Participants include patients with lymphoma, leukemia, plasma cell disorders, and those undergoing autologous stem cell transplantation or CAR-T therapy, with blood samples collected before vaccination and at scheduled follow-up visits. The trial aims to identify which formulation elicits the most robust humoral and cellular immunity in this severely immunocompromised population.
Who should consider this trial
Good fit: Adults aged 19 or older with a confirmed hematologic malignancy (for example, lymphoma, leukemia, or plasma cell disorders), including those before or after autologous stem cell transplant or CAR-T therapy, who can undergo repeated blood sampling are ideal candidates.
Not a fit: People who received an influenza vaccine within the past 6 months, have known hypersensitivity to vaccine components, have poor venous access or bleeding risk, or cannot comply with study procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify a vaccine approach that improves immune protection against influenza and reduces severe illness in people with blood cancers.
How similar studies have performed: Prior trials have suggested high-dose or adjuvanted vaccines might improve responses but did not consistently show superior antibody results, and comprehensive comparative data including T-cell responses in this population remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Difficulty with repeated venipuncture or blood sampling (e.g., poor vascular access or bleeding tendency) * Cognitive or psychiatric impairment precluding understanding of or cooperation with study procedures * Known hypersensitivity to influenza vaccine components * Influenza vaccination within the preceding 6 months * Any other condition deemed clinically inappropriate for study participation at investigator discretion
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Sung-Han Kim, MD, PhD — Asan Medical Center
- Study coordinator: So Yun Lim, MD, PhD
- Email: soyun_lim@amc.seoul.kr
- Phone: +82-10-4120-3816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Neoplasms, Influenza, Immunogenicity