Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatments herpes zoster vaccine gsk1437173a, placebo
Phase phase 3
Sponsor GlaxoSmithKline
Start date March 2014
End date May 2016
Trial size 265 participants
Trial identifier NCT02058589, 116886, 2012-005059-18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects will receive HZ/su vaccine on a 0- and 1- to 2-months schedule.
herpes zoster vaccine gsk1437173a
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
(Placebo Comparator)
Subjects will receive placebo on a 0- and 1- to 2-months schedule.
placebo
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Primary Outcomes

Measure
Evaluation of anti-gE humoral immunogenicity, in all subjects, in terms of vaccine response.
time frame: At Month 2.
Occurrence of solicited local and general symptoms.
time frame: Within 7 days (Days 0-6) after each vaccination.
Occurrence of unsolicited symptoms.
time frame: During 30 days (Days 0-29) after each vaccination.
Occurrence of serious adverse events (SAEs).
time frame: From the first vaccination up to 30 days post last vaccination.
Occurrence of adverse events of specific interest (AESIs).
time frame: From first vaccination up to 30 days post last vaccination.
Evaluation of allograft function.
time frame: From the first vaccination up to 30 days post last vaccination.

Secondary Outcomes

Measure
Evaluation of anti-gE humoral immunogenicity in terms of antibody concentrations.
time frame: Months 0, 1, 2, 7 and 13.
gE-specific CD4+ T-cell mediated immunogenicity, in the CMI sub-cohort.
time frame: Months 0, 2 and 13.
Occurrence of SAEs.
time frame: From 30 days post last vaccination until study end (Month 13).
Occurrence of AESIs.
time frame: From 30 days post last vaccination until study end (Month 13).
Evaluation of allograft function.
time frame: From 30 days post last vaccination until study end (Month 13).

Eligibility Criteria

Male or female participants at least 18 years old.

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. - Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo. - Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit. - Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies. - Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment. - Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe. - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. - Acute disease and/or fever at the time of vaccination. - Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.

Additional Information

Official title Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults 18 Years of Age or Older With Renal Transplant
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.