Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Human Immune Responses to Influenza Virus Vaccination in Patients With Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501576
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Andres Chang, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Diffuse Large B-Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Biological: Inactivated Influenza Vaccine Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine the seroprotection and seroconversion rates after influenza vaccination in patients with lymphoma receiving active treatment or in follow up observation.

SECONDARY OBJECTIVES:

I. To characterize influenza-specific plasmablasts and memory B cells after influenza vaccination in patients with lymphoma receiving active treatment or in follow up observation.

II. To investigate the longevity of 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 influenza vaccination.

IV. To assess the effect of different lymphomas and treatment modalities in the immune response to influenza 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, 14, 28, 90, and 180

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Human Immune Responses to Influenza Virus Vaccination in Patients With Lymphoma
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Experimental: Inactivated Influenza Vaccine
Patients receive seasonal inactivated influenza vaccine IM at day 0.
Biological: Inactivated Influenza Vaccine
Given seasonal inactivated influenza vaccine IM
Other Names:
  • Fluzone Quadrivalent
  • Fluzone Quadrivalent Influenza Vaccine
  • Quadrivalent Influenza Vaccine
  • Quadrivalent Inactivated Influenza Vaccine
  • Flu Vaccine




Primary Outcome Measures :
  1. Percentage of subjects achieving seroprotection defined as the percentage of subjects with a post-vaccination hemagglutination inhibition (HI) titer > 1:40 [ Time Frame: Up to 180 days after immunization ]
    Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.

  2. Percentage of subjects achieving seroconversion [ Time Frame: Up to 180 days after immunization ]
    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.


Secondary Outcome Measures :
  1. Measurement of influenza-specific serum antibody levels after influenza vaccination [ Time Frame: Up to 180 days after immunization ]
    For serum antibody responses directed against the influenza vaccine epitopes, endpoint IgG titers after vaccination at each time point will be determined.

  2. Measurement of influenza-specific plasmablasts (PBs) after influenza vaccination [ Time Frame: Up to 180 days after immunization ]
    PBs responses against influenza 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 influenza vaccination.

  3. Measurement of influenza-specific memory B-cells (MBCs) after influenza vaccination [ Time Frame: Up to 180 days after immunization ]
    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 influenza vaccination.

  4. Maximum fold rise in antibody titer [ Time Frame: Up to 180 days after immunization ]
    Hemagglutination inhibition assays will be used to assess the timing and strength of the peak immune response to influenza vaccination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of lymphoma falling into the following categories:

    • Diffuse large B-cell lymphoma (DLBCL) who have received 1 cycle of anthracycline-based chemotherapy
    • DLBCL in complete remission and within 12 months after completion of anthracycline-based chemotherapy
    • Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month
    • Follicular lymphoma (FL) in remission and on surveillance for 6 or more months
    • Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy
  • Subject capable of providing written 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/µL
  • 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

Exclusion Criteria:

  • Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); 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
  • Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components 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 current influenza 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 current influenza vaccination season
  • Subjects enrolled in hospice or whose life expectancy is less than 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501576


Contacts
Layout table for location contacts
Contact: Andres Chang, MD, PhD 404-778-3942 andres.chang@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mike Churnetski    404-778-3703    michael.c.churnetski@emory.edu   
Contact: Vanessa Smith    404-778-2419    vanessa.smith@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Andres Chang, MD, PhD Emory University
Layout table for additonal information
Responsible Party: Andres Chang, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03501576    
Other Study ID Numbers: IRB00101067
NCI-2017-02313 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship4236-17 ( Other Identifier: Winship Cancer Institute )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Lymphoma, B-Cell
Vaccines
Immunologic Factors
Physiological Effects of Drugs