Shingrix vaccine study probes skin immunity in young and old
NCT ID NCT04403139
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how the Shingrix vaccine, which protects against shingles, affects immune cells in the skin and blood. Researchers will give the vaccine to 50 healthy adults in two age groups: 30-40 years old and 70 years or older. They will measure specific antibodies and T-cells to understand how the vaccine triggers long-lasting immunity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shingrix (recombinant zoster vaccine)
- What this could lead to
- If successful, this study could help explain how the Shingrix vaccine protects against shingles, potentially improving future vaccines.
- What could go wrong
- This is a small, early-phase study with only 50 participants, so results may not apply to everyone. It measures immune markers, not actual disease prevention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Washington Virology Research Clinic
Seattle, Washington, 98104, United States
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