Overview

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

Status:
Unknown status
Trial end date:
2018-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Louis Stokes VA Medical Center
Collaborator:
Duke University
Treatments:
Vaccines
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