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

Neoplasms Clinical Trial

Official title:

Influenza Vaccination Response in Patients With Non-Hematological Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01695733
• Other study ID #: 201010722
• Status: Terminated
• Phase: Phase 1
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Biological:
• trivalent influenza vaccine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Report the presence of post-vaccination adverse events		4 weeks from the influenza vaccine

External Links

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