RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant

This research is looking at a new vaccine from GlaxoSmithKline (GSK) designed to prevent shingles in young people. Specifically, it's for children aged 1 to 17 who have received a kidney transplant. The main goals are to see how safe the vaccine is, what side effects it might cause, and how well it helps the body build protection against the shingles virus. Shingles is caused by the same virus as chickenpox, and it can be more serious in children with weakened immune systems, like those who have had an organ transplant. This study involves giving two doses of the vaccine and carefully monitoring the children afterwards.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

184

Start

25 Oct 2019

Estimated completion

31 Mar 2027

Herpes Zoster

What is this study about?

Shingles is a painful rash caused by the chickenpox virus becoming active again. While common in older adults, it can also affect children, especially those whose immune systems are not as strong. This is often the case for children who have had a kidney transplant, as they need to take medicines to stop their body from rejecting the new kidney. These medicines can make it harder for their body to fight off infections.

This study is trying to find a way to protect these children from shingles. Researchers are testing a new vaccine, called PED-HZ/su, developed by GSK. They want to see if this vaccine can safely help children with kidney transplants build up a defence against the shingles virus, without causing too many problems. This is important because preventing shingles could make a big difference to the health and well-being of these young patients.

The study is in its early stages (Phases 1 and 2), which means it's about understanding how the vaccine works and checking its safety in a smaller group of people, before potentially being tested in more people later on. The information gathered from this study will help doctors learn more about how to protect vulnerable children from shingles.

Key takeaways

Tests a new shingles vaccine (PED-HZ/su) for children with kidney transplants.
Aims to check vaccine safety and how well it helps prevent shingles.
For children aged 1 to 17 who had a kidney transplant over 6 months ago.
Involves 2 vaccine doses and close medical monitoring.
Participation is voluntary and can be stopped at any time.

Who may be eligible?

To be considered for this study, your child must be between 1 and 17 years old and weigh at least 6 kilograms (about 13 pounds). They must have had a kidney transplant more than six months ago, and their kidney function needs to be stable. They also need to be taking medicines to prevent their body from rejecting the new kidney, and have been on these medicines for at least a month.

It's important that your child has either had the chickenpox vaccination, a confirmed case of chickenpox, or a blood test showing they've been exposed to the chickenpox virus before their transplant. Parents or legal guardians must be willing to follow all study rules and give their written permission. Older children might also need to agree to take part themselves.

Some conditions would prevent your child from joining. For example, if their original kidney disease had a high chance of returning in the new kidney, or if there's any sign it has already returned in the transplanted kidney. Also, if they've lost a previous transplanted kidney because that original kidney disease came back.

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.

Is your child between 1 and 17 years old?
Does your child weigh at least 6 kg (about 13 lbs)?
Did your child have a kidney transplant over 6 months ago?
Has your child had chickenpox or the chickenpox vaccine before their transplant?
Is your child's kidney function currently stable?
Are you, as a parent or guardian, able to commit to study visits?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive two doses of the new vaccine. This will involve several visits to the study clinic where doctors and nurses will check their health, monitor for any side effects, and take blood samples to see how their immune system is responding to the vaccine. They will be carefully looked after throughout the study. The exact number of visits and the total length of time your child would be involved will be explained in full by the study team, but it will involve follow-up after the vaccinations are given.

Potential risks and benefits

Potential benefits of taking part include the possibility that your child could gain protection against shingles, which can be a serious illness in children with kidney transplants. However, as this is a new vaccine, there's always a chance it might not work or could cause unexpected side effects, similar to other vaccines. Any side effects will be carefully monitored. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (31)

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

GSK Investigational Site
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Brussels, Belgium· Recruiting
GSK Investigational Site
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Ghent, Belgium· Recruiting
GSK Investigational Site
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Leuven, Belgium· Recruiting
GSK Investigational Site
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Liège, Belgium· Recruiting
GSK Investigational Site
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Bordeaux, France· Recruiting
GSK Investigational Site
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Lille, France· Recruiting
GSK Investigational Site
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Marseille, France· Recruiting
GSK Investigational Site
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Montpellier, France· Recruiting
GSK Investigational Site
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Nantes, France· Withdrawn
GSK Investigational Site
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Paris, France· Recruiting
GSK Investigational Site
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Paris, France· Recruiting
GSK Investigational Site
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Toulouse, France· Recruiting

Common questions

What is shingles?

Shingles is a painful rash caused by the chickenpox virus. It can happen if the virus, which stays in the body after chickenpox, becomes active again.

Why are children with kidney transplants more at risk?

Children with kidney transplants take medicines that weaken their immune system to prevent organ rejection. This makes it harder for their body to fight off viruses like the one that causes shingles.

Is this vaccine already available?

No, this is a new vaccine that is still being tested in a study. It's not yet available for general use.

How many vaccine doses will my child receive?

Children taking part in this study will receive two doses of the vaccine.

What if we decide to leave the study?

You are free to leave the study at any time, for any reason. Your child's medical care will not be affected.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.