Considering recombinant herpes zoster vaccine for fragile pediatric patients: A new opportunity.
A Mollo, M Peri, L Lodi...
https://pubmed.ncbi.nlm.nih.gov/40198934Actively Recruiting
Phase 1
Phase 2
Age: 1Year - 17Years
All Genders
ID04006808
Reactogenicity, Safety and Immune Response Study of GSK's Pediatric Herpes Zoster Vaccine in Kidney Transplant Children
Led by GlaxoSmithKline · Updated on 2026-02-27
184
Participants Needed
31
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the reactogenicity, safety, and immune response of two doses of PED-HZ/su, GlaxoSmithKline's vaccine candidate, for preventing Herpes Zoster in immunocompromised children aged 1 to 17 years who have had a kidney transplant. This Phase 1/2 study focuses on pediatric renal transplant recipients to understand how the vaccine performs in this vulnerable group. Participants are divided by age and treatment into four groups: children aged 12 to 17 receiving the vaccine, similar-aged children receiving standard care without the vaccine, children aged 1 to 11 receiving the vaccine, and the youngest group receiving standard care. Vaccinated groups receive two intramuscular doses of PED-HZ/su in the deltoid muscle on day 1 and one month later. The younger age group enrollment is staggered, starting after safety data from the older group is reviewed. During the study, participants are monitored closely for local and general adverse events within seven days after each vaccination, as well as unsolicited adverse events and serious safety concerns up to two months post-vaccination. Researchers measure antibody levels one month after the second dose to assess immune response. Follow-up continues up to 13 months to track serious events, kidney transplant rejection, and occurrence of Herpes Zoster. The study includes careful assessment of seizures and other potential side effects related to the vaccine.
CONDITIONS
Brief Title
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Who Can Participate
Age: 1Year - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Parent or legal representative able and willing to comply with study requirements
- Written informed consent from parent/legal representative before study procedures
- Written informed assent from child when applicable
- Male or female aged 1 to 17 years at randomization
- Body weight of at least 6 kg
- Documented previous varicella vaccination, medically verified varicella infection, or positive varicella antibody before transplant
- Kidney transplant received more than six months before randomization
- ABO compatible allogeneic renal transplant
- Stable kidney function with less than 20% variability in creatinine levels or investigator opinion
- Receiving maintenance immunosuppressive therapy for at least one month before randomization
- Female of childbearing potential must use adequate contraception 30 days before and during treatment and for 2 months after vaccination series
You will not qualify if you...
- Primary kidney disease with high risk of recurrence in transplant
- Evidence of recurrent primary kidney disease in current transplant
- Previous transplant loss due to recurrent disease
- History of more than one organ transplant
- Acute transplant rejection episode within six months before enrollment
- Unknown panel reactive antibody score at transplant
- Unknown varicella antibody status before transplant
- Advanced chronic kidney disease
- Significant proteinuria believed renal in origin (≥ 200 g/mol creatinine)
- Lack of multiple dialysis options if needed
- History of unstable or progressive neurological disorder
- History of febrile seizures depending on age
- Varicella or Herpes Zoster episode within six months before enrollment
- Autoimmune diseases except specific listed nephropathies and diabetes with nephropathy
- Confirmed or suspected HIV or primary immunodeficiency
- Any condition increasing risk per investigator
- History of hypersensitivity to vaccine components
- Conditions making intramuscular injection unsafe
- Atypical Hemolytic Uremic Syndrome
- Use of investigational products or treatments for rejection recently or planned
- Use of certain monoclonal antibodies within one year
- Recent or planned blood product or immunoglobulin administration
- Recent vaccinations except certain influenza vaccines
- Previous Herpes Zoster vaccination
- Planned Herpes Zoster or varicella vaccine during study
- Participation in other clinical studies involving investigational or non-registered products
- Child in care
- Pregnant or breastfeeding female
- Planning pregnancy or stopping contraception during study period
- Evidence or suspicion of non-compliance with immunosuppressive therapies
- Failure to complete pre-vaccination diary card
- Study personnel or immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 1 month (two-dose schedule)
Participants receive two doses of the investigational vaccine administered intramuscularly in the deltoid of the non-dominant arm, or they receive standard care without the vaccine.
2 vaccination visits (in-person) plus multiple follow-up visits within 30 days after each vaccination
Follow-up
Duration - Up to 13 months
Participants are monitored for safety, adverse events, and immune response up to 13 months after the first vaccination.
Scheduled visits including assessments at Month 2 and Month 13
Trial Site Locations
Total: 31 locations
1
GSK Investigational Site
Brussels, Belgium, 1020
Actively Recruiting
2
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
3
GSK Investigational Site
Leuven, Belgium, 3000
Actively Recruiting
4
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
5
GSK Investigational Site
Bordeaux, France, 33000
Actively Recruiting
6
GSK Investigational Site
Lille, France, 59000
Actively Recruiting
7
GSK Investigational Site
Marseille, France, 13385
Actively Recruiting
8
GSK Investigational Site
Montpellier, France, 34295
Actively Recruiting
9
GSK Investigational Site
Nantes, France, 44093
Withdrawn
10
GSK Investigational Site
Paris, France, 75015
Actively Recruiting
11
GSK Investigational Site
Paris, France, 75019
Actively Recruiting
12
GSK Investigational Site
Toulouse, France, 31059
Actively Recruiting
13
GSK Investigational Site
Genova, Italy, 16147
Completed
14
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
15
GSK Investigational Site
Padova, Italy, 35128
Actively Recruiting
16
GSK Investigational Site
Roma, Italy, 00165
Actively Recruiting
17
GSK Investigational Site
Torino, Italy, 10126
Actively Recruiting
18
GSK Investigational Site
Gdansk, Poland, 80-952
Actively Recruiting
19
GSK Investigational Site
BaracaldoVizcaya, Spain, 48903
Actively Recruiting
20
GSK Investigational Site
Espluges de Llobregat, Spain, 08950
Completed
21
GSK Investigational Site
HebrOn, Spain, 08035
Actively Recruiting
22
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
23
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
24
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
25
GSK Investigational Site
Birmingham, United Kingdom, B4 6NH
Completed
26
GSK Investigational Site
Cardiff, United Kingdom, CF14 4XW
Completed
27
GSK Investigational Site
Glasgow Strathclyde, United Kingdom, G51 4TF
Actively Recruiting
28
GSK Investigational Site
London, United Kingdom, WC1N 3JH
Actively Recruiting
29
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
30
GSK Investigational Site
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
31
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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