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Gskvx000000014593

This article discusses the clinical trials of GSK’s Herpes Zoster vaccine, known as GSKVx000000014593, in immunocompromised children aged 1-17 who have received kidney transplants. The study aims to assess the safety, reactogenicity, and immune response of this vaccine in this specific patient population. The trials are designed to evaluate the vaccine’s potential in preventing Herpes Zoster (shingles) in these vulnerable children.

Table of Contents

What is GSKVX000000014593?

GSKVX000000014593 is an active substance in a new vaccine being developed by GlaxoSmithKline (GSK) to prevent Herpes Zoster, also known as shingles, in children with weakened immune systems[1]. This vaccine is specifically designed for children aged 1 to 17 years who have received kidney transplants and are taking medications to prevent their bodies from rejecting the new organ[1].

Target Population

The vaccine is intended for children who are immunocompromised, which means their immune system is not working as well as it should. This can happen because of the medications they need to take after receiving a kidney transplant[1]. These children are at a higher risk of developing shingles, which can be more severe in people with weakened immune systems.

How the Vaccine Works

GSKVX000000014593 is a subunit vaccine, which means it contains only a specific part of the virus that causes shingles. This part, called gE (glycoprotein E), helps stimulate the immune system to protect against the virus without causing an infection[1]. The vaccine is given as an injection into the muscle (intramuscular injection) in two doses, with the second dose given about a month after the first[1].

Clinical Trial Details

The vaccine is currently being studied in a Phase II clinical trial. This means researchers are testing how well it works and how safe it is in a small group of children before it can be approved for wider use[1]. The trial is:

  • Randomized: participants are randomly assigned to either receive the vaccine or be in a control group
  • Open-label: both the researchers and participants know who is receiving the vaccine
  • Multicentre: conducted at multiple hospitals or clinics

Safety and Effectiveness

The main goals of the study are to:

  1. Check how safe the vaccine is by monitoring any side effects that occur within 7 days after each dose[1]
  2. Measure how well the vaccine stimulates the immune system by looking at antibody levels in the blood one month after the second dose[1]
  3. Monitor for any serious side effects, immune-related conditions, or problems with the transplanted kidney for up to 13 months after vaccination[1]

Eligibility Criteria

To participate in the study, children must meet certain criteria, including:

  • Be between 1 and 17 years old
  • Have received a kidney transplant more than 6 months ago
  • Be taking medications to prevent rejection of the transplanted kidney
  • Have stable kidney function
  • Have previously been vaccinated against chickenpox or had chickenpox in the past[1]

There are also several reasons why a child might not be able to participate, such as having certain medical conditions or taking specific medications that could interfere with the study results[1].

Potential Benefits

If proven safe and effective, this vaccine could provide important protection against shingles for children who are at higher risk due to their weakened immune systems. Preventing shingles in these children could help avoid potentially serious complications and improve their overall health after kidney transplantation[1].

Aspect Details
Study Type Phase II, randomized, open-label, multicenter
Participants Immunocompromised children aged 1-17 with kidney transplants
Vaccine GSK’s paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) GSK143713A
Administration Two intramuscular doses, 0.5 ml each
Primary Objectives Evaluate reactogenicity, safety, and humoral immune responses
Secondary Objectives Long-term safety, occurrence of HZ cases, characterization of immune responses
Duration 13 months
Key Exclusions Previous HZ vaccination, recent varicella vaccination, multiple organ transplants

FAQ

  • What is the purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety, reactogenicity (how well the body tolerates the vaccine), and immune response of GSK's Herpes Zoster vaccine in immunocompromised children aged 1-17 who have had kidney transplants. The study aims to assess if the vaccine can help prevent shingles in this vulnerable group.
  • Who can participate in this trial? Participants must be between 1 and 17 years old, have had a kidney transplant more than six months ago, and be on stable immunosuppressive therapy. They must also have a history of chickenpox, previous vaccination against chickenpox, or be seropositive for the varicella-zoster virus before transplantation.
  • How is the vaccine administered? The vaccine is administered intramuscularly (into the muscle) on a two-dose schedule. The total dose is 1 ml, with each injection being 0.5 ml.
  • What are the main things being monitored during the trial? The trial monitors several aspects, including local and general side effects within 7 days after each vaccination, any unexpected side effects within 30 days, serious adverse events, potential immune-mediated diseases, and kidney transplant rejection. The study also measures the immune response to the vaccine by looking at antibody levels.
  • How long does the trial last? The trial lasts for 13 months. Participants are monitored closely for the first two months after vaccination, with continued follow-up until the 13-month mark to assess long-term safety and the occurrence of Herpes Zoster.

Ongoing Clinical Trials on Gskvx000000014593

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

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Greece Italy Poland Spain

Glossary

  • Herpes Zoster (HZ): Also known as shingles, it's a painful rash caused by reactivation of the varicella-zoster virus, which causes chickenpox. It's more common in people with weakened immune systems.
  • Immunocompromised: Having a weakened immune system, often due to certain diseases or medications. In this study, it refers to children who have had kidney transplants and are on immunosuppressive drugs.
  • Reactogenicity: The ability of a vaccine to produce common, expected adverse reactions, usually mild and self-limited, like soreness at injection site or mild fever.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Seropositive: Having a positive blood test result for a specific antibody, in this case, for varicella-zoster virus antibodies.
  • Allograft: A tissue or organ transplanted from one individual to another of the same species. In this study, it refers to the transplanted kidney.
  • Immunosuppressive therapy: Medications that lower the body's immune response to prevent rejection of transplanted organs.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • pIMD: Potential Immune-Mediated Disease, a group of conditions where the immune system attacks the body's own tissues.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-gsks-herpes-zoster-vaccine-in-immunocompromised-children-aged-1-17-with-kidney-transplants/