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Observational Study of Immune Response to Vaccination in Lymphoma Patients

This observational study is looking at how well people with lymphoma respond to vaccines, specifically the seasonal inactivated influenza vaccine. Researchers want to understand how your immune system (your body's defense against illness) reacts to these vaccines while you are being treated for lymphoma or after your treatment. They will measure antibody levels, which are proteins your immune system makes to fight off infections. This study includes people with various types of lymphoma, such as Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma. The goal is to see how well your body builds protection after vaccination. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It aims to enroll 200 participants.
What's involved
You would receive the seasonal inactivated influenza vaccine. After vaccination, you would have follow-up visits at days 7, 28, 90, 180, and 365.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 365 days after immunization to assess immune responses.

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NCT03501576

Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Recruiting
Not specifiedAges 18+Observational
Emory University
~200 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Inactivated Influenza Vaccine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40
Measured over Up to 180 days after immunization
+3 more outcomes measured

Conditions

Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaMantle Cell LymphomaMature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Andres Chang, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Andres Chang, MD, PhD
[email protected]
404-778-3942
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects with a diagnosis of lymphoma falling into the following categories:
B-NHL who have received 1 cycle of chemotherapy
B-NHL in complete remission and within 12 months after completion of chemotherapy
Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month
B-NHL in complete remission for over 12 months
Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy
Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.
Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:
Hemoglobin: 7.0-16.1 gm/dL
Platelet count: 10-600/µL
Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season \*- Platelet count: 10-600/uL
For cohort 1: Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.
For cohort 3: Subjects must have previously received at least 1 dose of SARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine will be eligible to enroll in cohort.

Exclusion

Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient
Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study
Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection
Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine
Have a history of Guillain-Barre syndrome (GBS)
Subjects who had or are suspected to have had an influenza infection in the current influenza season
Subjects who, at screening, have abnormal vital signs and/or physical exam, including a temperature ≥ 38.0 C, systolic blood pressure ≤ 90 or \> 180 mmHg, pulse ≤ 60 or \> 130 beats per minute, new rash, signs of infection
Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season
Subjects enrolled in hospice or whose life expectancy is less than 6 months

What this trial measures

  • Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40Up to 180 days after immunization

    Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.

  • Percentage of subjects achieving seroconversionUp to 180 days after immunization

    Seroconversion is defined as the percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \> 1:40 or a pre-vaccination HI titer \> 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer (day 0, 28). Rates of seroconversion will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.

  • Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose.Up to 365 days after immunization

    Assessments will be performed at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 8 after second dose of vaccine, and days 90, 180, and 365.

  • Cohort 3: Efficacy (immune response) of COVID vaccines at least 7 days after each booster vaccine dose.From baseline up to 365 days

    Assessments will be performed after each dose of SARS-CoV2 booster vaccine.