ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

Louis Stokes VA Medical Center

Status and phase: Unknown; Phase 4

Conditions: Shingles

Treatments: Drug: ZOSTAVAX

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02444936

Canaday Zostavax

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

ZOSTAVAX

Active Comparator group

Description:

ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

Treatment:

Drug: ZOSTAVAX

Control

No Intervention group

Description:

There is no drug given in this arm.