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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695733
Recruitment Status : Terminated (no longer had funding to continue)
First Posted : September 28, 2012
Last Update Posted : December 8, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Neoplasms Biological: trivalent influenza vaccine Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influenza Vaccination Response in Patients With Non-Hematological Malignancies
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Schedule A
Influenza vaccination on the first day of chemotherapy
Biological: trivalent influenza vaccine
Other Name: Flushield, Fluvirin, Fluzone, Influenza Vaccine
Experimental: Schedule B
Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy
Biological: trivalent influenza vaccine
Other Name: Flushield, Fluvirin, Fluzone, Influenza Vaccine

Primary Outcome Measures :
  1. Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule. [ Time Frame: 4 weeks from the influenza vaccine ]
    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.

Secondary Outcome Measures :
  1. Report the presence of post-vaccination adverse events [ Time Frame: 4 weeks from the influenza vaccine ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695733

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Principal Investigator: Saiama Waqar, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine Identifier: NCT01695733     History of Changes
Other Study ID Numbers: 201010722
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs