Clinical trial NCT04403139: VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
Official title: VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Varicella Zoster Virus Infection
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of gE-specific IgG in serum.
timeFrame: up to 1 year after vaccination
measure: Level of gE-specific CD4 T cells in blood
timeFrame: up to 1 year after vaccination
measure: Cytokine profile of gE-specific CD4 T cells in blood
timeFrame: up to 1 year after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Christine M Johnston, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: