Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
3 other identifiers
observational
200
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2018
CompletedFirst Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2026
February 11, 2026
February 1, 2026
8.1 years
April 10, 2018
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40
Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.
Up to 180 days after immunization
Percentage of subjects achieving seroconversion
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.
Up to 180 days after immunization
Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose.
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.
Up to 365 days after immunization
Cohort 3: Efficacy (immune response) of COVID vaccines at least 7 days after each booster vaccine dose.
Assessments will be performed after each dose of SARS-CoV2 booster vaccine.
From baseline up to 365 days
Secondary Outcomes (4)
Measurement of virus-specific serum antibody levels after vaccination
Up to 180 days after immunization
Measurement of virus-specific plasmablasts (PBs) after influenza vaccination
Up to 180 days after immunization
Measurement of virus-specific memory B-cells (MBCs) after vaccination
Up to 180 days after immunization
Maximum fold rise in antibody titer
Up to 180 days after immunization
Study Arms (3)
Inactivated Influenza Vaccine
Patients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine
Qualifying subjects to receive a SARS-CoV2 vaccine.
Patients receive a SARS-CoV2 vaccine.
Clinical Group Receiving SARS-CoV2 Booster Vaccines
Patients receive a SARS-CoV2 vaccine.
Interventions
Given seasonal inactivated influenza vaccine IM
Eligibility Criteria
20 patients per observation group
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (2)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Chang, MD, PhD
Emory University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2018
First Posted
April 18, 2018
Study Start
April 6, 2018
Primary Completion (Estimated)
May 26, 2026
Study Completion (Estimated)
May 26, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02