Clinical trial NCT01610414: Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Official title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Keywords: Observer-blind
Efficacy
Immunogenicity
Vaccination
Safety
Adult autologous haematopoietic cell transplant recipients
Herpes Zoster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 1877
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.


Eligibility criteria: Inclusion Criteria:

Study entry (enrollment) occurs at the Pre-vaccination visit.

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female aged 18 years or older at the time of study entry.
* Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
* Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).

Exclusion Criteria:

* 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. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
* Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
* Planned administration during the study of a HZ vaccine other than the study vaccine.
* Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
* Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
* Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
* HIV infection by clinical history.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).

Primary outcomes:
measure: Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
timeFrame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Secondary outcomes:
measure: Duration of 'Worst' HZ-associated Pain
timeFrame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
measure: Number of Subjects With Confirmed HZ-associated Complications
timeFrame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
measure: Number of Subjects With Postherpetic Neuralgia (PHN)
timeFrame: From Month 0 until study end (21 months median follow-up)
measure: Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects
timeFrame: At Months 0, 1, 2, 13 and 25
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
timeFrame: From Month 0 up to 365 days post last vaccination
measure: Number of Subjects With Any Relapse
timeFrame: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
measure: Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo
timeFrame: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
measure: Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination
timeFrame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
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facility: GSK Investigational Site
state: California
city: Aurora
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facility: GSK Investigational Site
state: Colorado
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state: Kansas
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state: Kentucky
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state: Massachusetts
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state: Michigan
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state: New York
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state: New York
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state: North Carolina
city: Durham
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state: North Carolina
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city: Philadelphia
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state: Pennsylvania
city: Philadelphia
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state: Texas
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state: Wisconsin
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state: New South Wales
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state: New South Wales
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state: Victoria
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facility: GSK Investigational Site
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state: Ontario
city: Montreal
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state: Quebec
city: Quebec City
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state: Saskatchewan
city: Hradec Kralove
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city: Helsinki
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city: Turku
country: Finland
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city: Clermont-Ferrand Cedex 1
country: France
facility: GSK Investigational Site
city: Créteil cedex
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facility: GSK Investigational Site
city: Grenoble cedex 9
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
city: Athens
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facility: GSK Investigational Site
city: Athens
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city: Athens
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city: Athens
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city: Thessaloniki
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facility: GSK Investigational Site
city: Hong Kong
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city: Hafia
country: Israel
facility: GSK Investigational Site
city: Jerusalem
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Emilia-Romagna
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Romania
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Plumstead
country: South Africa
facility: GSK Investigational Site
state: Western Province
city: Groenkloof
country: South Africa
facility: GSK Investigational Site
city: Moreleta Park, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Badalona/Barcelona
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facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
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city: Barcelona
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city: La Coruña
country: Spain
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city: León
country: Spain
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city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Murcia (El Palmar)
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
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city: Santander
country: Spain
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city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Swindon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Cottingham
country: United Kingdom
facility: GSK Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Curran D, Matthews S, Rowley SD, Young JH, Bastidas A, Anagnostopoulos A, Barista I, Chandrasekar PH, Dickinson M, El Idrissi M, Heras I, Milliken ST, Monserrat Coll J, Navarro Matilla MB, Oostvogels L, Piatkowska-Jakubas B, Quiel D, Sabry W, Schwartz S, Selleslag DLD, Sullivan KM, Theunissen K, Yegin ZA, Yeh SP, Zaja F, Szer J; ZOE-HSCT Study group collaborators. Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT). Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036. Epub 2019 Aug 5.
citation: Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, Lopez-Jimenez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053.