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OpenTrials
Active, Not Recruiting

NCT Number: NCT04403139

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

To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shingrix

Drug

All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 27, 2020
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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