Varicella Zoster Virus InfectionPhase 4NCT04403139
VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
A Phase 4 study testing Shingrix in people with Varicella Zoster Virus Infection, run by University of Washington at 1 site in United States.
Trial summary
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella Zoster Virus Infection
- What is being tested?
- Shingrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort 1: 30-40 years of age
- Cohort 2: 70 years of age or older
- HIV seronegative
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Virology Research Clinic
Seattle, Washington, 98104
About this study
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
Read the 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.
- Conditions
- Varicella Zoster Virus Infection
- Being tested
- Shingrix
- Medical subject headings
- Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixDrug
All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 30-40 year of age | Other | Not described Receives: Drug: Shingrix |
| Cohort 2: 70 years of age or older | Other | Not described Receives: Drug: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of gE-specific IgG in serum.
Units will be optical density at 492 nanometers from ELISA.
Measured: 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.
Measured: 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
Measured: up to 1 year after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella Zoster Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christine Johnston, University of Washington
- Investigators
- Christine M Johnston, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403139
- Sponsor's protocol ID
- STUDY00009255
- Other IDs
- R01AG064800
- Status last verified
- Apr 2026
- First submitted
- 21 May 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
- ClinicalTrials.gov ID
- NCT04403139
- Acronym / sponsor ID
- STUDY00009255
- Conditions
- Varicella Zoster Virus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 30-40 year of age | Other | Drug: Shingrix |
| Cohort 2: 70 years of age or older | Other | Drug: Shingrix |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cohort 1: 30-40 years of age
- Cohort 2: 70 years of age or older
- HIV seronegative
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShingrixAll participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule. | Drug | Cohort 1: 30-40 year of age, Cohort 2: 70 years of age or older |
Primary outcome
Level of gE-specific IgG in serum.
Time frame: up to 1 year after vaccination
Units will be optical density at 492 nanometers from ELISA.
Level of gE-specific CD4 T cells in blood
Time frame: up to 1 year after vaccination
Units will be cells per million CD4+ T cells in blood.
Cytokine profile of gE-specific CD4 T cells in blood
Time frame: up to 1 year after vaccination
Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Johnston, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shingrix in people with Varicella Zoster Virus Infection, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of gE-specific IgG in serum. (time frame: up to 1 year after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.