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