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

University of Washington

Status and phase

Active, not recruiting

Phase 4

Conditions

Varicella Zoster Virus Infection

Treatments

Drug: Shingrix

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04403139

R01AG064800 (U.S. NIH Grant/Contract)

STUDY00009255

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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.