Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy

Influenza Vaccination Response in Patients With Non-Hematological Malignancies

This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.

Study Overview

• Status: Terminated
• Conditions: Neoplasms
• Intervention / Treatment: Biological: trivalent influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have biopsy-confirmed non-hematological malignancy
• Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
• Patients must be of age >=18 years.
• Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination
• Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
• Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
• Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen
• Patients must not be on any other agents that can suppress the immune system
• Planned concurrent therapy with radiation
• Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness
• Psychiatric illness/social situations that would limit compliance with study requirements
• Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response
• History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study
• Patient may not be scheduled to receive chemotherapy on a weekly basis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Schedule A; Influenza vaccination on the first day of chemotherapy	Biological: trivalent influenza vaccine; Other Names: Flushield, Fluvirin, Fluzone, Influenza Vaccine
EXPERIMENTAL: Schedule B; Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy	Biological: trivalent influenza vaccine; Other Names: Flushield, Fluvirin, Fluzone, Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.	We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.	4 weeks from the influenza vaccine

Secondary Outcome Measures

Outcome Measure	Time Frame
Report the presence of post-vaccination adverse events	4 weeks from the influenza vaccine

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 201010722