Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

NCT ID: NCT03501576

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2026-05-26

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the seroprotection and seroconversion rates after influenza or SARS-CoV2 vaccination in patients with lymphoma receiving active treatment or in follow up observation.

SECONDARY OBJECTIVES:

I. To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.

II. To investigate the longevity of viral-specific humoral immunity to influenza virus in patients with lymphoma receiving active treatment or in follow up observation.

III. To assess the timing and strength of the peak immune response to vaccination.

IV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.

OUTLINE:

Patients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0.

After completion of study treatment, patients are followed up at days 7, 28, 90, 180, and 365.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inactivated Influenza Vaccine

Patients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine

Inactivated Influenza Vaccine

Intervention Type: BIOLOGICAL

Given seasonal inactivated influenza vaccine IM

Qualifying subjects to receive a SARS-CoV2 vaccine.

Patients receive a SARS-CoV2 vaccine.

No interventions assigned to this group

Clinical Group Receiving SARS-CoV2 Booster Vaccines

Patients receive a SARS-CoV2 vaccine.

No interventions assigned to this group

Interventions

Inactivated Influenza Vaccine

Given seasonal inactivated influenza vaccine IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone Quadrivalent; Fluzone Quadrivalent Influenza Vaccine; Quadrivalent Influenza Vaccine; Quadrivalent Inactivated Influenza Vaccine; Flu Vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Andres Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andres Chang, MD, PhD

Role: CONTACT

andres.chang@emory.edu

404-778-3942

Facility Contacts

Michael Churnetski

Role: primary

michael.c.churnetski@emory.edu

404-778-3703

Mike Churnetski

Role: primary

michael.c.churnetski@emory.edu

404-778-3703

Vanessa Smith

Role: backup

vanessa.smith@emory.edu

404-778-2419

Other Identifiers

NCI-2017-02313

Identifier Type: REGISTRY

Identifier Source: secondary_id

Winship4236-17

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00101067

Identifier Type: -

Identifier Source: org_study_id