Recruiting

Vaccination

Sponsor:

Emory University

Code:

NCT03501576

Conditions

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inactivated Influenza Vaccine

Study Details

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.

Conditions

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

Mantle Cell Lymphoma

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Study ID

NCT03501576

Start date

Apr 6, 2018

Status verified date

Jul, 2026

Completion date

May 26, 2028

Anticipated

Primary completion date

May 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Inactivated Influenza Vaccine

Given seasonal inactivated influenza vaccine IM

Primary outcome measure

  • 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 ]
  • Percentage of subjects achieving seroconversion [ Time Frame: Up to 180 days after immunization ]
  • Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose. [ Time Frame: Up to 365 days after immunization ]
  • 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 ]

Central Contacts and Locations

Central contacts

Andres Chang, MD, PhD

404-778-3942andres.chang@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Michael Churnetski

404-778-3703michael.c.churnetski@emory.edu

Principal Investigator:

Andres Chang, MD, PhD

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mike Churnetski

404-778-3703michael.c.churnetski@emory.edu

Vanessa Smith

404-778-2419vanessa.smith@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-06.