ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

NCT ID: NCT02444936

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2018-05-01

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.

Conditions

Shingles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

ZOSTAVAX

ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

Group Type: ACTIVE_COMPARATOR

ZOSTAVAX

Intervention Type: DRUG

Shingles vaccine

Control

There is no drug given in this arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ZOSTAVAX

Shingles vaccine

Intervention Type: DRUG

Other Intervention Names

Voster vaccine live

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Louis Stokes VA Medical Center

FED

Sponsor Role: lead

Responsible Party

David Canaday

Associate Director of Research, GRECC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David H. Canaday, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland VA

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Canaday Zostavax

Identifier Type: -

Identifier Source: org_study_id