Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

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 ofchemotherapy

• Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receivingibrutinib 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 ofchemotherapy

• Subject capable of providing written or electronic informed consent prior toinitiation of any study procedures; subjects able to understand and comply withplanned study procedures and be available for all study visits.

• Screening labs must be within the following ranges or considered to be notclinically 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 fluseason and are not suspected to have had an influenza infection in the current fluseason *- Platelet count: 10-600/uL

• For cohort 1: Subjects who have not received the seasonal influenza vaccine inthe current flu season and are not suspected to have had an influenza infectionin the current flu season.

• For cohort 3: Subjects must have previously received at least 1 dose ofSARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine willbe eligible to enroll in cohort.

Exclusion Criteria:

• Known infection with human immunodeficiency virus (HIV). This information will beobtained verbally from the patient

• Have any medical disease or condition that, in the opinion of the site principalinvestigator is a contraindication to study participation; this includes any chronicmedical 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 subjectunable to meet the requirements of the protocol, or may interfere with theevaluation of responses or the subject?s successful completion of this study

• Have an acute illness, as determined by the site principal investigator within 72hours prior to study vaccination; an acute illness which is nearly resolved withonly minor residual symptoms remaining is allowable if, in the opinion of the siteprincipal investigator, the residual symptoms will not interfere with the ability toassess safety parameters as required by the protocol and was not due to an influenzainfection

• Subjects taking long-term systemic steroids defined as greater than 3 months in thepast 12 months

• Have known hypersensitivity or allergy to eggs, egg or chicken protein, or othercomponents 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 currentinfluenza 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 currentinfluenza vaccination season

• Subjects enrolled in hospice or whose life expectancy is less than 6 months