Clinical trial NCT02444936: ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Official title: A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shingles
Keywords: solid tumor
chemotherapy
vaccine
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
Collaborators: name: Duke University
First posted: 2015-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.

Detailed description: This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.

Eligibility criteria: Inclusion Criteria:

* Solid organ tumor patients that have at least 14 days between entry into the study with ZOSTAVAX vaccination and initial therapy for their malignancy that will include chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation therapy
* A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6 months of our sample collection phase of the study

Exclusion Criteria:

* Prior history of HZ or shingles vaccine
* Systemic chemotherapy \< 3 months prior to enrollment
* Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant, or other cellular immunodeficiency state
* Those receiving immunomodulating drugs at the time of vaccination such as prednisone methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha inhibitors
* Widespread metastatic tumor with bone marrow involvement
* Indefinite duration palliative chemotherapy subjects

  * Inability to communicate with the study staff or bring unable to consent for themselves
  * History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other components of the vaccine

Primary outcomes:
measure: Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
timeFrame: 3 years
measure: Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland VA
name: David H. Canaday, MD
role: PRINCIPAL_INVESTIGATOR
References: