Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant

NCT ID: NCT02058589

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-20
• Study Completion Date: 2017-04-13

Brief 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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GSK1437173A Group

Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine GSK1437173A

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Placebo Group

Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Interventions

Herpes Zoster vaccine GSK1437173A

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Intervention Type: BIOLOGICAL

Placebo

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Intervention Type: DRUG

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Parma, Emilia-Romagna, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Siena, Tuscany, Italy

GSK Investigational Site

Treviso, Veneto, Italy

GSK Investigational Site

Panama City, , Panama

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Barakaldo (Vizcaya), , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Córdoba, , Spain

GSK Investigational Site

L'Hospitalet de Llobregat, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Santander, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Keelung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan District, , Taiwan

Countries

Belgium; Canada; Czechia; Finland; Italy; Panama; South Korea; Spain; Taiwan

References

Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernandez Rodriguez AM, Rebollo Rodrigo H, Campins Marti M, Perez R, Gonzalez Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers L, Aguera Morales ML, Rodriguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Z-041 Study Group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177.

Reference Type: DERIVED

PMID: 30843046 (View on PubMed)

Other Identifiers

2012-005059-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116886

Identifier Type: -

Identifier Source: org_study_id