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

NCT01695733 | Terminated Phase 1

• 1 other identifier: 201010722
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Report the presence of post-vaccination adverse events

  4 weeks from the influenza vaccine

Study Arms (2)

Schedule A

EXPERIMENTAL

Influenza vaccination on the first day of chemotherapy

Biological: trivalent influenza vaccine

Schedule B

EXPERIMENTAL

Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy

Biological: trivalent influenza vaccine

Interventions

trivalent influenza vaccine BIOLOGICAL

Also known as: Flushield, Fluvirin, Fluzone, Influenza Vaccine

Schedule A; Schedule B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Saiama Waqar, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)