ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of 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.

Study Overview

• Status: Unknown
• Conditions: Shingles
• Intervention / Treatment: Drug: ZOSTAVAX

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ZOSTAVAX; ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection	Drug: ZOSTAVAX; Shingles vaccine; Other Names: Voster vaccine live
No Intervention: Control; There is no drug given in this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)	To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.	3 years
Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures	To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.	3 years

Collaborators and Investigators

• Sponsor: Louis Stokes VA Medical Center
• Collaborators: Duke University
• Investigators: Principal Investigator: David H. Canaday, MD, Cleveland VA

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: chemotherapy; vaccine; solid tumor
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Canaday Zostavax