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Immune Response to Shingles Vaccination

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: NCT02624375
Recruitment Status : Completed
First Posted : December 8, 2015
Results First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Christine Johnston, University of Washington

Brief Summary:
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).

Condition or disease Intervention/treatment Phase
Shingles Drug: Zoster Vaccine Live Phase 4

Detailed Description:
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immune Response to Shingles Vaccination
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: 10 persons over 70 years of age that received Zostavax
10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)
Drug: Zoster Vaccine Live
Other Name: ZOSTAVAX




Primary Outcome Measures :
  1. Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood [ Time Frame: 6 months ]
    To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood

  2. Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin [ Time Frame: 4 weeks ]
    To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events Due to Zostavax [ Time Frame: 6 months ]
    To measure the occurrence of adverse events after Zostavax.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 70 years of age or older.
  • History of chickenpox.

Exclusion Criteria

  • Previous vaccination with Zostavax or with the chickenpox vaccine.
  • History of ever having had shingles.
  • Been in close contact with a person who had chickenpox or shingles in the past 5 years.
  • VZV seronegative
  • Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
  • HIV seropositive.
  • Hepatitis C infection or active Hepatitis B infection.
  • History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
  • Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
  • Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
  • Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
  • Donated blood in the past 8 weeks or planning to donate blood during the study
  • Weighs less than 110 lbs
  • Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Additional exclusions for optional skin biopsy:

  1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
  2. History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
  3. History of keloid formation or excessive scarring
  4. History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
  5. Allergy to lidocaine, silver nitrate, or mupirocin.

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): NCT02624375


Locations
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United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Christine Johnston, University of Washington:
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Responsible Party: Christine Johnston, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02624375    
Other Study ID Numbers: STUDY00001399
53354 ( Other Grant/Funding Number: Merck )
First Posted: December 8, 2015    Key Record Dates
Results First Posted: December 5, 2019
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections