Actively Recruiting
Evaluation of Human Immune Responses to Vaccination in Patients With Lymphoma
Led by Emory University · Updated on 2026-02-11
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune response to influenza and SARS-CoV2 vaccinations in patients diagnosed with various types of lymphoma. The goal is to better understand how the immune system changes during and after lymphoma treatment by measuring antibody levels and immune cell activity over time compared to individuals without lymphoma. This observational study is sponsored by Emory University and includes patients receiving active treatment or under follow-up observation. Participants receive an FDA-approved seasonal inactivated influenza vaccine given by intramuscular injection on day 0. Some participants also receive SARS-CoV2 vaccines or booster doses. Following vaccination, participants are monitored at days 7, 28, 90, 180, and 365 to assess immune responses. The study tracks virus-specific plasmablasts, memory B cells, and antibody levels to evaluate the strength, timing, and duration of immunity. During the study, participants undergo blood tests to measure seroprotection, seroconversion, and virus-specific immune cells. Researchers evaluate the immune response up to 180 days for influenza vaccines and up to 365 days for SARS-CoV2 vaccines. Safety is monitored through vital signs and clinical assessments. The total study duration includes vaccination and follow-up visits over one year to understand how different lymphoma types and treatments affect vaccine response.
CONDITIONS
Brief Title
Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of lymphoma including B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, mantle cell lymphoma, or aggressive peripheral T-cell lymphoma
- Have received at least one cycle of chemotherapy or are in complete remission within 12 months after chemotherapy
- Patients receiving ibrutinib for at least one month if diagnosed with chronic lymphocytic leukemia or mantle cell lymphoma
- Able to provide written or electronic informed consent and comply with study procedures
- Screening laboratory tests within acceptable ranges as determined by the investigator
- For cohort 1: Not received the current season's influenza vaccine and no suspected influenza infection in the current season
- For cohort 3: Previously received at least one dose of SARS-CoV2 vaccine; those without prior SARS-CoV2 vaccination may enroll in cohort 1
You will not qualify if you...
- Known infection with human immunodeficiency virus (HIV)
- Any medical condition that may pose unacceptable risk or interfere with study participation as judged by the investigator
- Acute illness within 72 hours prior to vaccination unless minor residual symptoms not affecting safety assessments
- Long-term use of systemic steroids exceeding three months in the past year
- Known allergies to eggs, egg proteins, chicken proteins, or vaccine components
- History of Guillain-Barre syndrome (GBS)
- Suspected or confirmed influenza infection in the current season
- Abnormal vital signs or physical exam at screening including fever, low or high blood pressure, abnormal pulse, new rash, or signs of infection
- Already received the seasonal influenza vaccine in the current vaccination season
- Enrolled in hospice or with life expectancy less than six months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive seasonal inactivated influenza vaccine intramuscularly.
1 vaccination visit (in-person)
Duration - Up to 365 days
Participants are followed up to assess immune responses and antibody levels after vaccination.
Visits on days 7, 28, 90, 180, and 365 (in-person)
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
A
Andres Chang, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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