Evaluation of Human Immune Responses to Vaccination in Patients with Lymphoma
This study evaluates the effect of vaccination on 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.
Inclusion Criteria
- Subjects 18 years of age or above with a diagnosis of lymphoma falling into the following categories: * B-cell non-Hodgkin lymphoma (B-NHL) who have received 1 cycle of chemotherapy * B-NHL in complete remission and within 12 months after completion of chemotherapy * B-NHL in complete remission for over 12 months * Aggressive Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma (PTCL) who have received 1 cycle of chemotherapy * B-NHL on 2+ lines of therapy * Untreated NHL/chronic lymphocytic leukemia (CLL)
- 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
- Hemoglobin: 7.0-16.1 gm/dL
- Platelet count: 10-600/uL
- 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
- 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 2
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 who have a contraindication for influenza or SARS-CoV-2 vaccination
- Subjects who have already received the current influenza or SARS-CoV-2 vaccine
- Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
- Subjects enrolled in hospice or whose life expectancy is less than 6 months
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03501576.
Locations matching your search criteria
United States
Georgia
Atlanta
PRIMARY OBJECTIVE:
I. To determine the seroprotection and seroconversion rates after influenza or severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination in patients with lymphoma receiving active treatment or in follow up observation.
SECONDARY OBJECTIVES:
I. To characterize virus-specific plasmablasts, memory B cells, and T cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.
II. To investigate the longevity of virus-specific immunity 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 are assigned to 1 of 2 cohorts.
COHORT 1: Patients receive seasonal inactivated influenza vaccine per standard of care. Patients undergo collection of blood samples at baseline, and 7, 28, 90, and 180 days after vaccination.
COHORT 2 (CLOSED TO ACCRUAL 01/10/2025): Patients receive SARS-CoV-2 vaccine per standard of care. Patients undergo collection of blood samples at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 7 after second dose of vaccine, and days 90, 180, and 365.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAndres Chang
- Primary IDWINSHIP4236-17
- Secondary IDsNCI-2017-02313, IRB00101067
- ClinicalTrials.gov IDNCT03501576