ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

NCT02444936 | Unknown Phase 4 Results

• 1 other identifier: Canaday Zostavax
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shingles

Keywords

solid tumor; chemotherapy; vaccine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

ZOSTAVAX

ACTIVE COMPARATOR

ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

Drug: ZOSTAVAX

Control

NO INTERVENTION

There is no drug given in this arm.

Interventions

ZOSTAVAX DRUG

Shingles vaccine

Also known as: Voster vaccine live

ZOSTAVAX

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead
• Duke University: collaborator

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. David Canaday
• Organization: Cleveland VA

dxc44@case.edu

216-368-8901

Study Officials

• David H. Canaday, MD

  Cleveland VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research, GRECC

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-04