NCT03501576 · Emory University
Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
What this study is about
This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma.
View original scientific description
This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.
Interventions
BIOLOGICAL
Inactivated Influenza Vaccine
Given seasonal inactivated influenza vaccine IM
Primary outcome measures
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40
Time frame: Up 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 seroconversion
Time frame: Up 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.
Time frame: 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.
Time frame: From baseline up to 365 days
Assessments will be performed after each dose of SARS-CoV2 booster vaccine.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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: Hematology:
- 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 criteria
- 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
Where
- Atlanta, Georgia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations