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VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination

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ClinicalTrials.gov Identifier: NCT04403139
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : December 19, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Christine Johnston, University of Washington

Study Description
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Brief Summary:
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells

Condition or disease Intervention/treatment Phase
Varicella Zoster Virus Infection Drug: Shingrix Phase 4

Detailed Description:
This is an interventional study of vaccination related to infection with varicella zoster virus. We will enroll participants of two age groups. Cohort 1 will be persons between the ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Memory Vaccines

Arms and Interventions
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Arm Intervention/treatment
Cohort 1: 30-40 year of age Drug: Shingrix
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
Cohort 2: 70 years of age or older Drug: Shingrix
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.


Outcome Measures
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Primary Outcome Measures :
  1. Level of gE-specific IgG in serum. [ Time Frame: up to 1 year after vaccination ]
    Units will be optical density at 492 nanometers from ELISA.

  2. Level of gE-specific CD4 T cells in blood [ Time Frame: up to 1 year after vaccination ]
    Units will be cells per million CD4+ T cells in blood.

  3. Cytokine profile of gE-specific CD4 T cells in blood [ Time Frame: up to 1 year after vaccination ]
    Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cohort 1: 30-40 years of age
  • Cohort 2: 70 years of age or older
  • HIV seronegative

Exclusion Criteria:

  • Previous vaccination with Shingrix (RZV), Zostavax (ZVL, zoster vaccine live), or with the chickenpox vaccine
  • VZV seronegative
  • Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic evidence of hepatitis C infection that has cleared spontaneously, or with a history of treated hepatitis C with a sustained virologic response, can be enrolled. Persons with a history of resolved hepatitis B infection (negative for hepatitis B surface antigen) can be enrolled
  • History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to any component of the vaccine
  • History of receipt of an organ transplant or hematopoietic stem cell transplant
  • Significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other condition which in the past has required significant immune modifying medication or which has a clinical course that is characterized by relapses
  • 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, breastfeeding, or planning to become pregnant 3 months post vaccination
  • Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
  • History of coagulopathy or taking medication that may cause bleeding (long term high dose aspirin, heparin, coumadin). Aspirin doses <100 mg daily allowed
  • History of keloid formation or excessive scarring
  • History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy
  • Allergy to lidocaine, silver nitrate, or mupirocin
  • 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.
Contacts and Locations
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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): NCT04403139


Contacts
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Contact: Virology Research Clinic 206-520-4340 vrc@uw.edu

Locations
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United States, Washington
University of Washington Virology Research Clinic Recruiting
Seattle, Washington, United States, 98104
Contact    206-520-4340    vrc@u.washington.edu   
Sponsors and Collaborators
University of Washington
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Christine M Johnston, MD, MPH University of Washington
More Information
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Responsible Party: Christine Johnston, Associate Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04403139    
Other Study ID Numbers: STUDY00009255
R01AG064800 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Virus Diseases
 Infections
Herpesviridae Infections
DNA Virus Infections