VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
Primary Purpose
Varicella Zoster Virus Infection
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Shingrix
Sponsored by
About this trial
This is an interventional basic science trial for Varicella Zoster Virus Infection
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.
Sites / Locations
- University of Washington Virology Research ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cohort 1: 30-40 year of age
Cohort 2: 70 years of age or older
Arm Description
Outcomes
Primary Outcome Measures
Level of gE-specific IgG in serum.
Units will be optical density at 492 nanometers from ELISA.
Level of gE-specific CD4 T cells in blood
Units will be cells per million CD4+ T cells in blood.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04403139
First Posted
May 21, 2020
Last Updated
December 15, 2022
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04403139
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella Zoster Virus Infection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: 30-40 year of age
Arm Type
Other
Arm Title
Cohort 2: 70 years of age or older
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Shingrix
Intervention Description
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
Primary Outcome Measure Information:
Title
Level of gE-specific IgG in serum.
Description
Units will be optical density at 492 nanometers from ELISA.
Time Frame
up to 1 year after vaccination
Title
Level of gE-specific CD4 T cells in blood
Description
Units will be cells per million CD4+ T cells in blood.
Time Frame
up to 1 year after vaccination
Title
Cytokine profile of gE-specific CD4 T cells in blood
Description
Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines
Time Frame
up to 1 year after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virology Research Clinic
Phone
206-520-4340
Email
vrc@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Johnston, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
206-520-4340
Email
vrc@u.washington.edu
12. IPD Sharing Statement
Learn more about this trial
VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
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