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.
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
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
20 patients per observation group
Cohort
Prospective
Inactivated Influenza Vaccine
Biological/VaccineGiven seasonal inactivated influenza vaccine IM
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.
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.
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.
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.
Measurement of virus-specific serum antibody levels after vaccination
For serum antibody responses directed against the vaccine epitopes, endpoint IgG titers after vaccination at each time point will be determined.
Measurement of virus-specific plasmablasts (PBs) after influenza vaccination
PBs responses against influenza or SARS-CoV2 will be determined by direct ex vivo enzyme-linked immunospot (ELISPOT). Changes in the PB population will be measured to assess the timing and strength of the peak immune response to vaccination.
Measurement of virus-specific memory B-cells (MBCs) after vaccination
The frequency of hemagglutinin (HA)-specific immunoglobulin G (IgG)-secreting MBCs per total IgG-secreting cells after vaccination will be determined. Changes in the MBC population will be measured to assess the timing and strength of the peak immune response to vaccination.
Maximum fold rise in antibody titer
Hemagglutination inhibition assays will be used to assess the timing and strength of the peak immune response to vaccination.
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