Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
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.
Arms & interventions
- BiologicalInactivated Influenza Vaccine
Given seasonal inactivated influenza vaccine IM
Outcome measures
Primary
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.
Time frame: Up to 180 days after immunization
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.
Time frame: Up to 180 days after immunization
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.
Time frame: Up to 365 days after immunization
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.
Time frame: From baseline up to 365 days
Secondary
Measurement of virus-specific serum antibody levels after vaccination
Time frame: Up to 180 days after immunization
Measurement of virus-specific plasmablasts (PBs) after influenza vaccination
Time frame: Up to 180 days after immunization
Measurement of virus-specific memory B-cells (MBCs) after vaccination
Time frame: Up to 180 days after immunization
Maximum fold rise in antibody titer
Time frame: Up to 180 days after immunization
Eligibility criteria
Study locations (2)
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322