Phase 3
Completed N=264
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant
Source: ClinicalTrials.gov NCT02058589 ↗Enrolled (actual)
264
Serious AEs
22.4%
Results posted
Aug 2018
Primary outcomePrimary: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity — 97; 5 Participants
◆ Published Evidence
Highly cited
193citations · ~32 / year
Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.
Summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.
Linked Publications
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Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity |
97; 5 | — |
| PRIMARY Number of Subjects With Solicited Local Symptoms |
107; 8; 10; 0; 24; 1 | — |
| PRIMARY Days With Solicited Local Symptoms |
3.0; 1.5; 3.0; 1.0; 3.0; 1.0 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms |
47; 42; 3; 3; 8; 2 | — |
| PRIMARY Days With Solicited General Symptoms |
3.0; 3.0; 3.0; 4.5; 3.0; 4.0 | — |
| PRIMARY Number of Subjects With Unsolicited Symptoms (AEs) |
51; 44; 7; 5; 7; 3 | — |
| PRIMARY Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) |
0; 0 | — |
| PRIMARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
6; 5; 0; 0 | — |
| PRIMARY Number of Subjects With Renal Allograft Rejection |
4; 7; 12; 13 | — |
| PRIMARY Number of Subjects With Changes in Allograft Function |
17; 22; 4; 3; 3; 1 | — |
| SECONDARY Anti-gE Antibody Concentrations |
1354.4; 1495.7; 9530.5; 1501.9; 19163.8; 1489.4 | — |
| SECONDARY Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity |
77; 3; 83; 5; 74; 7 | — |
| SECONDARY Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells |
110.9; 165.75; 2433.07; 156.98; 1320.92; 129.41 | — |
| SECONDARY Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells |
20; 0; 17; 0 | — |
| SECONDARY Number of Subjects With Any and Related SAEs |
21; 29; 0; 1 | — |
| SECONDARY Number of Subjects With Any pIMDs |
4; 2 | — |
| SECONDARY Number of Subjects With Renal Allograft Rejection |
4; 7; 12; 13 | — |
| SECONDARY Number of Subjects With Changes in Allograft Function |
17; 22; 4; 3; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female, aged 18 years or older and having reached the age of legal consent, on the date the informed consent is signed.
- Written informed consent obtained from the subject.
- Subject who has received an ABO compatible allogeneic renal transplant.
- Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to the first vaccination.
- Subject without an episode of allograft rejection over the previous three months (90 days) prior to the first vaccination.
- Subject with stable renal function, stability defined as:
- less than 20% variability between last two creatinine measurements or calculated GFR
- or in the opinion of the investigator after investigator review of more than the last two creatinine measurements or calculated GFRs.
- Subject not less than 4 months (120 days) and not more than 18 months (547 days) after allograft transplantation at the time of the first vaccination.
- Subjects with multiple dialysis options (peritoneal and/or more than one anatomical access site for haemodialysis) in the event acute or chronic dialysis is needed.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of the first vaccination, and
- has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria
- Any primary kidney disease with a high incidence of recurrent primary kidney disease.
- Evidence of recurrent primary kidney disease within the current allograft.
- Previous allograft loss secondary to recurrent primary kidney disease.
- Multiple kidney transplants are allowed if the reason for a previous allograft's loss is not recurrent primary kidney disease.
- More than one organ transplanted (i.e. kidney-liver, double kidney or kidney-other organ(s) transplanted).
- History of events that, in the opinion of the investigator, may put subject at increased risk for chronic allograft dysfunction (e.g. delayed graft function, peri-operative complications).
- Histologic reports of chronic allograft injury (e.g. transplant glomerulopathy, arteriopathy, C4d deposition).
- Evidence of significant proteinuria in the opinion of the investigator.
- Panel reactive antibody score (PRA or cPRA) that is unknown at the time of transplant.
- Any autoimmune or potential immune-mediated disease including primary kidney disease.
- Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine/placebo.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
- Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered product
- Administration or planned administration of a live vaccine within 30 days prior to the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
- Planned administration during the study of a varicella or HZ vaccine other than the study vaccine.
- Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Data sourced from ClinicalTrials.gov (NCT02058589) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.