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Study on Long-Term Effects and Safety of Herpes Zoster Vaccine with Recombinant Varicella Zoster Virus Glycoprotein E in Older Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Herpes Zoster, commonly known as shingles, which is a painful skin rash caused by the reactivation of the chickenpox virus. The study is evaluating a vaccine called Shingrix, which is designed to prevent shingles. Shingrix is a type of vaccine that uses a part of the virus, known as a recombinant varicella zoster virus glycoprotein E, to help the body build protection against the disease.

The purpose of this study is to assess how well the Shingrix vaccine works over a long period, how safe it is, and how long the immune response lasts in older adults. Participants in the study will receive one or two additional doses of the vaccine. The study will follow participants for several years to monitor their health and the effectiveness of the vaccine in preventing shingles.

Throughout the study, participants will have regular check-ups to track their immune response and any side effects. The study will also look at the number of confirmed cases of shingles among participants and measure specific immune cells and antibodies that help protect against the virus. This information will help determine the long-term benefits and safety of the Shingrix vaccine for preventing shingles in older adults.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are required to provide written or witnessed/thumb printed informed consent. This consent is necessary before any study-specific procedures are performed.

    Participants must be medically stable, as determined by a medical history review and clinical examination.

  2. Step 2

    Initial visit

    During the initial visit, participants will receive the **Shingrix** vaccine, which is a **Herpes zoster** vaccine. This vaccine is administered as a **suspension for injection**.

    The vaccine is given **intramuscularly**, meaning it is injected into a muscle.

  3. Step 3

    Follow-up visits

    Participants are required to return for follow-up visits at specific intervals: **Months 12, 24, 36, and 48**.

    During these visits, blood samples may be taken to measure **anti-gE antibody concentrations** and the frequency of specific immune cells.

  4. Step 4

    Monitoring and documentation

    Participants are expected to complete **Herpes zoster-specific diary cards** and **quality of life questionnaires** throughout the study.

    These documents help track any symptoms or side effects experienced during the study.

  5. Step 5

    End of study

    The study is expected to conclude by **August 23, 2027**.

    Participants will have a final evaluation to assess the long-term efficacy and safety of the vaccine.

Who can join the trial?

4 criteria

  • Participants who, in the opinion of the study doctor, can and are willing to follow the study rules. This includes completing specific diary cards and questionnaires about their quality of life, attending follow-up visits, and being available for scheduled contacts during the study. If a participant has a caregiver, the caregiver must also be able and willing to follow these rules.
  • Participants must provide written consent to join the study. If they cannot write, a witness can help, or they can use a thumbprint to show their agreement.
  • Participants must be medically stable, meaning their health condition is steady and not likely to change suddenly, as determined by their medical history and a physical examination before joining the study.
  • Participants must have completed the ZOSTER-049 study, which means they received at least one dose of the HZ/su vaccine in the previous ZOSTER-006 or ZOSTER-022 studies.

Who cannot join the trial?

3 criteria

  • Patients who have a current or past diagnosis of Herpes Zoster (also known as shingles) cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

Herpes Zoster Subunit Vaccine This vaccine is designed to protect against shingles, a painful rash caused by the reactivation of the chickenpox virus in the body. The vaccine works by boosting the immune system's ability to fight off the virus, reducing the risk of developing shingles. In this study, researchers are looking at how well the vaccine works over a long period and how safe it is for older adults. They are also checking if additional doses can help maintain the immune response.

What is already known about the treatment

Herpes Zoster Subunit Vaccine – This vaccine is administered as an injection to help prevent shingles, a painful skin rash caused by the reactivation of the chickenpox virus. It is currently being studied in a long-term follow-up clinical trial to assess its effectiveness, safety, and how long the immune response lasts in older adults. The vaccine works by stimulating the body's immune system to recognize and fight the virus if it becomes active again. It is classified as a vaccine, which is a type of medicine that helps the body build protection against infectious diseases.

Investigated diseases

Herpes Zoster – Herpes Zoster, also known as shingles, is a viral infection caused by the reactivation of the varicella-zoster virus, which also causes chickenpox. It typically presents as a painful rash that develops on one side of the body or face, often in a stripe or band-like pattern. The rash is usually accompanied by blisters that scab over in 7 to 10 days. Before the rash appears, there may be pain, itching, or tingling in the area where it will develop. The condition can also cause fever, headache, and fatigue. Over time, the rash and blisters heal, but some individuals may experience lingering pain known as postherpetic neuralgia.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505255-51-00Protocol code217917Estimated enrolment3 571 patientsSponsorGlaxoSmithKline Biologicals

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