Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers

NCT ID: NCT04484532

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2022-06-07

Brief Summary

This pilot research trial studies the antibody response to high-dose seasonal influenza vaccination in patients with myeloid malignancy receiving chemotherapy and healthy volunteers. Evaluating antibody response to high-dose seasonal influenza vaccine may serve as a basis for vaccine recommendations in patients with myeloid malignancies and provide insights into the status of the immune system in these patients.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate the antibody response to influenza vaccination in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving hypomethylating agents (decitabine or azacytidine) compared to normal healthy controls and those patients with similar disorders receiving cytarabine containing intensive chemotherapy or best supportive care.

II. To collect and store blood samples at different time points (prior to and after vaccination) for assessment of influenza specific T-cell subsets using tetramers by flow cytometry.

OUTLINE:

Within 14 days of baseline influenza titer, patients receive trivalent influenza vaccine intramuscularly (IM) on day 0 (patients in cohorts 1 and 5 receive the vaccine at any time, patients in cohorts 2 and 3 receive the vaccine between days 14-25 of hypomethylating agent therapy course, and patients in cohort 4 receive the vaccine between days 21-365 from onset of cytotoxic chemotherapy). Patients then undergo titer assessment at days 25-90 and days 115-185.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (trivalent influenza vaccine)

Within 14 days of baseline influenza titer, patients receive trivalent influenza vaccine IM on day 0 (patients in cohorts 1 and 5 receive the vaccine at any time, patients in cohorts 2 and 3 receive the vaccine between days 14-25 of hypomethylating agent therapy course, and patients in cohort 4 receive the vaccine between days 21-365 from onset of cytotoxic chemotherapy). Patients then undergo titer assessment at days 25-90 and days 115-185.

Group Type: EXPERIMENTAL

Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

Given IM

Interventions

Trivalent Influenza Vaccine

Given IM

Intervention Type: BIOLOGICAL

Other Intervention Names

Agriflu; Flu prevention; Flu prophylaxis; Flu shot; Flu vaccination; Fluarix; Flublok; FluLaval; Flushield; Fluvirin; Fluzone High-dose (HD); Influenza Vaccine; Influenza Virus Vaccine, Trivalent, Types A and B; Trivalent Influenza Vaccine (TIV)

Eligibility Criteria

Inclusion Criteria

• Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to undergoing any investigational biospecimen (blood) collection procedure
• Willing to undergo seasonal influenza vaccination with Fluzone high dose at Roswell Park Cancer Institute within 2 weeks of enrollment of this study
• Estimated survival of 8 weeks or more following enrollment on the study

Exclusion Criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active influenza infection or influenza-like-illness
• Women who are attempting pregnancy or known to be pregnant by clinical history or nursing female subjects
• Unwilling or unable to follow protocol requirements
• Use of prednisone > 10 mg/day (or its equivalent for other steroids) for > 2 weeks immediately prior to receiving seasonal influenza vaccination
• Received dose of seasonal influenza vaccination prior to enrollment
• Participation at the time of study enrollment in another clinical trial investigating immunotherapeutic agents (like anti-PD1 or anti-PDL1 or anti-CTLA4 antibodies or vaccines); concurrent participation in an observational/non-interventional study or an interventional study investigating tyrosine kinase inhibitor or other targeted agents use is acceptable
• Inability to receive seasonal influenza vaccine due to prior hypersensitivity to eggs, chicken proteins, or any of the vaccine components
• History of a life-threatening reaction to influenza vaccination or to a vaccine containing similar substances
• Personal history of Guillain-Barre syndrome
• Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive annual influenza vaccination or may potentially affect the response to influenza vaccination
• Adults unable to consent, individuals who are not yet adults (infants, children, and teenagers), women who are known to be pregnant, attempting pregnancy, or nursing women, and prisoners will be excluded from the study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A Griffiths

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2017-02157

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 54017

Identifier Type: OTHER

Identifier Source: secondary_id

I 54017

Identifier Type: -

Identifier Source: org_study_id