Active not recruitingPHASE3INTERVENTIONAL

A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

This study focuses on a vaccine designed to prevent shingles, which is caused by the chickenpox virus. Researchers want to understand how effective this shingles vaccine is in older people over a long period, specifically between 11 and 15 years after they first received it. They will also check if the body's protective response (immunity) is still strong and if the vaccine remains safe to use. This research builds on earlier studies and will also look at whether giving one or two extra doses of the vaccine to a small group of participants, five years after their initial vaccination, helps to boost their immunity and remains safe. The main goal is to ensure the vaccine offers lasting protection and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

3,038

Start

10 Aug 2022

Estimated completion

23 Aug 2027

Herpes Zoster

What is this study about?

This study is a long-term check-up on a vaccine developed to prevent shingles. Shingles is a painful rash caused by the same virus that causes chickenpox. The vaccine, called HZ/su, has already been given to many older people in previous studies. Now, the researchers want to find out how well it keeps working over a very long time – specifically, 11 to 15 years after people first got the vaccine.

They will be looking at three main things: Firstly, how good the vaccine is at preventing shingles over these many years (this is called 'vaccine efficacy'). Secondly, they want to see if the body's immune system, which is what fights off diseases, still remembers how to protect against shingles effectively. Thirdly, they will check if there are any new safety concerns that appear over such a long period.

This study is important because it will give us valuable information about how durable the protection from this shingles vaccine is. It also includes a smaller part looking at whether extra doses of the vaccine, given several years later, can further boost protection. Understanding long-term effects helps doctors and patients make informed decisions about vaccination.

Key takeaways

This study is checking how well a shingles vaccine works over 11-15 years.
It also looks at how long your body's protection against shingles lasts.
Researchers are carefully checking the vaccine's long-term safety.
It's for people who were already in previous shingles vaccine studies.
A small group might get extra vaccine doses to see if it boosts protection.

Who may be eligible?

To be considered for this study, you must have already taken part in a previous study of this shingles vaccine (either ZOSTER-006, ZOSTER-022, or ZOSTER-049) and have received at least one dose of the HZ/su vaccine. It's really important that you and anyone helping you understand the study are willing and able to follow all the study's instructions.

Before joining, a doctor will check your medical history and do an examination to make sure you are in good health and medically stable. You will also need to give your written permission to take part, after fully understanding what the study involves.

There are also some reasons why you might not be able to join. For example, if your doctor thinks taking part could put your health at extra risk, or if you're currently taking any experimental medicines or vaccines for shingles or chickenpox. You also can't be taking part in another study at the same time that involves medicines or treatments for shingles or chickenpox.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have previously participated in a shingles vaccine study (ZOSTER-006, ZOSTER-022, or ZOSTER-049).
I received at least one dose of the HZ/su vaccine in one of the earlier studies.
I am generally healthy enough to take part, as decided by the study doctor.
I am not currently using any experimental treatments for shingles or chickenpox.
I am not taking part in another study that tests treatments for shingles/chickenpox.

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to be monitored for a long time. This typically involves regular check-ups at a clinic where doctors will assess your health. You might have blood samples taken to see how your immune system is responding to the vaccine. The study may also involve answering questionnaires about your health and any illnesses you experience. Participants in a small group might receive one or two additional doses of the HZ/su vaccine, given two months apart. The total duration of your participation in this long-term follow-up study will vary depending on when you joined the earlier studies, but it is designed to track you for many years.

Potential risks and benefits

Participating in any study has potential benefits and risks. The main benefit is helping researchers understand the long-term effectiveness and safety of the shingles vaccine, which can benefit future public health. There are no direct personal medical benefits guaranteed, as the vaccine's main effects would have been seen in prior studies. Potential risks could include side effects from blood draws (like bruising or discomfort), or rarely, unexpected reactions to the vaccine, though it has already been given to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (107)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Phoenix, United States
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Elkridge, United States
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Charlotte, United States
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Hickory, United States
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Pittsburgh, United States
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Bristol, United States
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San Antonio, United States
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Salt Lake City, United States
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Warrawong, Australia
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Westmead, Australia
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Geelong, Australia
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Belo Horizonte, Brazil

Common questions

What is shingles?

Shingles is a painful rash that develops on one side of the body or face. It is caused by the same virus that causes chickenpox, which can become active again later in life.

What does 'long-term follow-up' mean?

It means the study will continue to check on participants for many years after they first received the vaccine to see how it performs over time.

Who is the HZ/su vaccine for?

This vaccine is generally for older adults to help prevent shingles.

Will I get more vaccine doses in this study?

Only a small group of participants will receive one or two additional doses of the vaccine, about five years after their initial vaccination.

What is 'immune response persistence'?

This refers to how long your body's immune system continues to remember and fight off the shingles virus after vaccination.