Study on the Safety and Immune Response of GSK’s Herpes Zoster Vaccine in Immunocompromised Children Aged 1-17 with Kidney Transplants

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What is this study about?

This clinical trial is focused on studying the prevention of Herpes Zoster, commonly known as shingles, in children and teenagers who have had a kidney transplant and are taking medications that weaken their immune system. The treatment being tested is a new vaccine developed by GlaxoSmithKline, referred to as the paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su). This vaccine is given as an injection into the muscle in two doses.

The purpose of the study is to assess how well the vaccine works and how safe it is for children and teenagers aged 1 to 17 years. Participants will receive two doses of the vaccine, and the study will monitor their reactions to the vaccine, including any side effects, over a period of time. The study will also measure the immune response, which is how the body defends itself against the virus, after receiving the vaccine.

Participants will be observed for any immediate reactions to the vaccine for up to seven days after each dose and for any other side effects for up to two months. The study will also look at the levels of antibodies, which are proteins in the blood that help fight infections, to see how well the vaccine is working. This information will help determine if the vaccine is a safe and effective way to prevent shingles in children and teenagers with weakened immune systems due to kidney transplants.

1 initial visit and consent

Upon joining the study, the parent or legally acceptable representative will provide written consent for participation. If applicable, the child will also provide assent.

Eligibility will be confirmed, ensuring the child is between 1 and 17 years old, has a stable renal function, and meets other specific criteria.

2 first vaccination

The child will receive the first dose of the Herpes Zoster subunit candidate vaccine as an intramuscular injection. This is a suspension for injection.

The child will be monitored for any immediate reactions following the injection.

3 monitoring period after first dose

For the first 7 days after the vaccination, any local or general symptoms will be recorded. This includes any reactions at the injection site or general symptoms like fever.

For 30 days after the vaccination, any unexpected symptoms or adverse events will be documented.

4 second vaccination

Approximately one month after the first dose, the child will receive the second dose of the Herpes Zoster subunit candidate vaccine as an intramuscular injection.

The child will again be monitored for any immediate reactions following the injection.

5 monitoring period after second dose

For the first 7 days after the second vaccination, any local or general symptoms will be recorded.

For 30 days after the second vaccination, any unexpected symptoms or adverse events will be documented.

6 follow-up visits

The child will have follow-up visits up to two months after the second dose to monitor safety and immune response.

During these visits, blood samples may be taken to evaluate the immune response to the vaccine.

7 long-term follow-up

The child will be monitored for any serious adverse events, immune-mediated diseases, or renal transplant rejection up to 13 months after the first vaccination.

The occurrence of Herpes Zoster will also be tracked during this period.

Who Can Join the Study?

The child’s parent(s) or legally acceptable representative(s) must be able and willing to follow the study rules, like filling out diary cards and coming back for follow-up visits.
The child must be receiving ongoing treatment to prevent organ rejection for at least one month before starting the study.
Female participants who can have children must use effective birth control for 30 days before starting the study and continue using it during the study and for 2 months after the last vaccination.
Written or witnessed consent must be obtained from the child’s parent(s) or legally acceptable representative(s) before any study procedures are done.
Written agreement (assent) from the child is needed if required by local rules.
The child must be between 1 and 17 years old at the time of starting the study.
The child must weigh at least 6 kg (13.23 pounds).
The child must meet at least one of the following:
- Has had a previous vaccination for varicella zoster virus (VZV), which causes chickenpox.
- Has had chickenpox confirmed by a doctor.
- Has a positive blood test for VZV before organ transplant.
The child must have had a kidney transplant more than six months before starting the study.
The child must have received a kidney transplant from a donor with a compatible blood type.
The child must have stable kidney function, meaning there is less than 20% change in kidney function tests, or the doctor agrees the kidney function is stable after reviewing multiple tests.

Who Cannot Join the Study?

Patients who have a known allergy to any component of the vaccine cannot participate.
Patients who have had a severe allergic reaction to a previous dose of a similar vaccine are excluded.
Patients with a weakened immune system due to conditions like HIV/AIDS or cancer cannot take part.
Patients currently receiving treatments that weaken the immune system, such as chemotherapy or steroids, are not eligible.
Patients with a history of herpes zoster (shingles) are excluded.
Patients who have received another vaccine within 4 weeks prior to the study cannot participate.
Patients with a fever or acute illness at the time of enrollment are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with any other medical condition that the study doctors believe would make participation unsafe are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Hospital Universitario De Cruces	Barakaldo	Spain
CHC MontLegia	Liege	Belgium
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
Assistance Publique Hopitaux De Paris	Paris	France
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Amxdwpw Ogmxxeldlrx Uxeiezxdispsn Cyyqdblhbsnw Dcbzq Siwbep E Dpgob Sthwbsi Di Ttuqms	Turin	Italy
Unrqvrojsjqlee Craoajy Knsbbzpoh	Gdansk	Poland
Afseksvepq Ptdzpbcb Hykktfot Dq Mndtzmhkb	Marseille	France
Fiahnxbqn Pelt Ls Iajsrnedxfcuz Baruhqhgf Dbs Huxlzqmr Uipfkugxuvrsg Lc Pth	Madrid	Spain
Hndpxwul Vxss ddydador	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.10.2019
France	Not recruiting	25.10.2019
Greece	Not recruiting	25.10.2019
Italy	Not recruiting	25.10.2019
Poland	Not recruiting	25.10.2019
Spain	Not recruiting	25.10.2019

Trial locations

Investigated drugs:

Gskvx000000014593

PED-HZ/su is a vaccine being studied for its ability to protect children who have had a kidney transplant and are immunocompromised, meaning their immune systems are weaker than usual. This vaccine is designed to prevent shingles, a painful rash caused by the same virus that causes chickenpox. The study is looking at how safe the vaccine is and how well it works in children aged 1 to 17 years. The researchers are checking for any side effects shortly after the vaccine is given and are also measuring how well the children’s immune systems respond to the vaccine over a couple of months.

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. After a person recovers from chickenpox, the virus remains dormant in the nerve tissue and can reactivate years later as Herpes Zoster. The disease typically presents as a painful rash that develops on one side of the body or face, often in a stripe pattern. The rash can form blisters that scab over in 7 to 10 days and usually clears up within 2 to 4 weeks. Some individuals may experience pain, itching, or tingling in the area before the rash appears. In some cases, the pain associated with Herpes Zoster can persist even after the rash has healed, a condition known as postherpetic neuralgia.

Trial ID:

2022-502784-37-00

Protocol code:

200075

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Immune Response of GSK’s Herpes Zoster Vaccine in Immunocompromised Children Aged 1-17 with Kidney Transplants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?