VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
NCT ID: NCT04403139
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2022-04-27
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1: 30-40 year of age
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
Shingrix
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
Interventions
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Shingrix
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
Eligibility Criteria
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Inclusion Criteria
* Cohort 2: 70 years of age or older
* HIV seronegative
Exclusion Criteria
* 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.
30 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Washington
OTHER
Responsible Party
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Christine Johnston
Associate Professor: School of Medicine
Principal Investigators
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Christine M Johnston, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington Virology Research Clinic
Seattle, Washington, United States
Countries
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Other Identifiers
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STUDY00009255
Identifier Type: -
Identifier Source: org_study_id
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