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