Evaluation of Human Immune Responses to Vaccination in Patients with Lymphoma

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Non-Hodgkin Lymphoma	NCT ID:	NCT03501576
Trial Phases:		Protocol IDs:	Winship4236-17 (primary) NCI-2017-02313 IRB00101067
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03501576

Summary

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.

Objectives

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 and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.
II. To investigate the longevity of virus-specific humoral 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 intramuscularly (IM) at day 0. Patients undergo collection of blood samples at baseline, and 7, 14, 28, 90, and 180 days after vaccination.

COHORT 2: 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 8 after second dose of vaccine, and days 90, 180, and 365.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.