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

NCT04484532 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: I 54017NCI-2017-02157
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Antibody response (by microneutralization assay) to influenza vaccination

  The geometric mean (GMT) and standard deviation of antibody titers will be calculated by cohort at the baseline assessment and 1-3 months post vaccination time points. Antibody response is assessed using the outcome measures: seroprotection, seroconversion, and GMT. Seroprotection is defined as an hemagglutination inhibition (HAI) titer \>= 1:40 of each individual influenza antigen. Seroconversion is defined as \>= 4-fold increase in post-vaccination titer of each individual influenza antigen. The seroprotection and seroconversion rates will be reported by age strata, cohort, and time-point (1-3 months and 4-6 months post vaccination) using 95% confidence intervals obtained using Jeffrey's prior method. The GMT at each time-point will be compared using one-sided permutation T-tests about the log-transformed data. The GMT ratio (GMTR) between 1-3 months post vaccination and baseline will also be calculated and reported by cohort using a 95% confidence interval.

  Up to 4-6 months post-vaccination

Secondary Outcomes (1)

• T-cell subset population assessed using flow cytometry

  Up to 4-6 months post-vaccination

Study Arms (1)

Supportive Care (trivalent influenza vaccine)

EXPERIMENTAL

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.

Biological: Trivalent Influenza Vaccine

Interventions

Trivalent Influenza Vaccine BIOLOGICAL

Given IM

Also known as: 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)

Supportive Care (trivalent influenza vaccine)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Influenza Vaccines; fluarix; FluBlok; FluLaval; Fluzone High-Dose

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Elizabeth A Griffiths

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: October 17, 2017
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

US (1)