Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444936
Recruitment Status : Active, not recruiting
First Posted : May 15, 2015
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
David Canaday, Louis Stokes VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Shingles Drug: ZOSTAVAX Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Active Comparator: ZOSTAVAX
ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection
Drug: ZOSTAVAX
Shingles vaccine
Other Name: Voster vaccine live

No Intervention: Control
There is no drug given in this arm.



Primary Outcome Measures :
  1. Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT) [ Time Frame: 3 years ]
    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.

  2. 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 [ Time Frame: 3 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444936


Sponsors and Collaborators
Louis Stokes VA Medical Center
Duke University
Investigators
Layout table for investigator information
Principal Investigator: David H. Canaday, MD Cleveland VA
  Study Documents (Full-Text)

Documents provided by David Canaday, Louis Stokes VA Medical Center:
Statistical Analysis Plan  [PDF] October 14, 2014
Informed Consent Form  [PDF] October 9, 2014
Study Protocol  [PDF] April 13, 2017


Layout table for additonal information
Responsible Party: David Canaday, Associate Director of Research, GRECC, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT02444936    
Other Study ID Numbers: Canaday Zostavax
First Posted: May 15, 2015    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: April 2018
Keywords provided by David Canaday, Louis Stokes VA Medical Center:
solid tumor
chemotherapy
vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs