Clinical trial NCT04484532: Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers
Official title: Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Antibody response (by microneutralization assay) to influenza vaccination
timeFrame: Up to 4-6 months post-vaccination
Secondary outcomes:
measure: T-cell subset population assessed using flow cytometry
timeFrame: Up to 4-6 months post-vaccination
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Elizabeth A Griffiths
role: PRINCIPAL_INVESTIGATOR
References: