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

NCT04403139 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY00009255R01AG064800
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Varicella Zoster Virus Infection

Outcome Measures

Primary Outcomes (3)

• Level of gE-specific IgG in serum.

  Units will be optical density at 492 nanometers from ELISA.

  up to 1 year after vaccination

• Level of gE-specific CD4 T cells in blood

  Units will be cells per million CD4+ T cells in blood.

  up to 1 year after vaccination

• Cytokine profile of gE-specific CD4 T cells in blood

  Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines

  up to 1 year after vaccination

Study Arms (2)

Cohort 1: 30-40 year of age

OTHER

Drug: Shingrix

Cohort 2: 70 years of age or older

OTHER

Drug: Shingrix

Interventions

Shingrix DRUG

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

Cohort 1: 30-40 year of age; Cohort 2: 70 years of age or older

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Varicella Zoster Virus Infection

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Christine M Johnston, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Medicine

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: April 27, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)