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

• Sponsor: University of Washington (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04403139
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Level of gE-specific IgG in serum. [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 [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 [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

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Virology Research Clinic	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Christine M Johnston, MD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christine Johnston, Associate Professor: School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04403139
• Other Study ID Numbers: STUDY00009255; R01AG064800
• First Posted: May 27, 2020
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• 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: Herpes Zoster; Varicella Zoster Virus Infection

Study Results

No Results Posted as of Jan 18, 2022