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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

High-Dose Trivalent Influenza Vaccine or Standard-Dose Quadrivalent Inactivated Influenza Vaccine in Treating Adult Stem Cell Transplant Recipients

This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn’t work as well. Influenza vaccine may provide better protection against flu in adults.
Not Available
Phase II
Adults
Not Available
Not Available
Halasa, Natasha
Local
Fred Hutchinson Cancer Research Center, Northwestern University, University of Alabama/Birmingham, Vanderbilt University
10-09-2017
Prevention
VICCBMT1733
NCT03179761

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Allogeneic HSCT recipients who are 3-23 months post-transplant

Available for duration of study

Patients with stable graft versus host disease (GVHD) for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable)

Can be reached by telephone and/or electronic communication

Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects
FOR REPEATERS: Available for duration of study

FOR REPEATERS: Can be reached by telephone and/or electronic communication

FOR REPEATERS: Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable)

FOR REPEATERS: Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects


Exclusion Criteria:

History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein

History of Guillain-Barre syndrome

Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms are permitted)

History of receiving current seasonal influenza vaccine post-transplant

Pregnant female

History of proven influenza disease after September 1, 2018 prior to enrollment

Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients

History of known active infection with human immunodeficiency virus (HIV)

History of cirrhosis

History of known latex hypersensitivity

Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment

Receipt of intravenous immunoglobulin therapy (IVIG)/subcutaneous immunoglobulin therapy (SCIG)
FOR REPEATERS: Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted)

FOR REPEATERS: History of receiving current seasonal influenza vaccine post-transplant

FOR REPEATERS: Pregnant female

FOR REPEATERS: History of proven influenza disease after September 1, 2018 prior to enrollment

FOR REPEATERS: History of known active infection with HIV

FOR REPEATERS: History of cirrhosis

FOR REPEATERS: Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment

FOR REPEATERS: Receipt of IVIG/SCIG

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