ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
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.
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.
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