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

Study Overview

• Status: Recruiting
• Conditions: Varicella Zoster Virus Infection
• Intervention / Treatment: Drug: Shingrix

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Virology Research Clinic; Phone Number: 206-520-4340; Email: vrc@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington Virology Research Clinic
      • Contact: Phone Number: 206-520-4340; Email: vrc@u.washington.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Christine M Johnston, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Varicella Zoster Virus Infection
• Other Study ID Numbers: STUDY00009255; R01AG064800 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• 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