Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Emory University

Status and phase

Enrolling

Phase 1

Conditions

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

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-Cell Lymphoma

Chronic Lymphocytic Leukemia

Treatments

Biological: Inactivated Influenza Vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT03501576

Winship4236-17 (Other Identifier)

IRB00101067

NCI-2017-02313 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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