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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02624375
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : April 3, 2018
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)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immune Response to Shingles Vaccination
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Intervention Details:
  • Drug: Zoster Vaccine Live
    Other Name: ZOSTAVAX

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

  2. Levels of VZV-specific CD4 or CD8 T cells in skin [ Time Frame: 4 weeks ]
    To determine if shingles disease boosts the local level of VZV-specific CD4 or CD8 T cells in skin 4 weeks after Zostavax

Secondary Outcome Measures :
  1. 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

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.

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

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 identifier (NCT number): NCT02624375

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Contact: Study Coordinator Virology Research Clinic 206-520-4340

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United States, Washington
University of Washington Virology Research Clinic Recruiting
Seattle, Washington, United States, 98104
Contact: Christine Johnston, MD, MPH    206-520-4340   
Principal Investigator: Christine Johnston, MD, MPH         
Sponsors and Collaborators
University of Washington
Merck Sharp & Dohme Corp.

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Responsible Party: Christine Johnston, Associate Professor, University of Washington Identifier: NCT02624375     History of Changes
Other Study ID Numbers: STUDY00001399
53354 ( Other Grant/Funding Number: Merck )
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
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
Immunologic Factors
Physiological Effects of Drugs