Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: Placebo; Biological: Herpes Zoster vaccine GSK1437173A

• Study Type: Interventional
• Enrollment (Actual): 1877
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • GSK Investigational Site
    • Waratah, New South Wales, Australia, 2298
      • GSK Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • GSK Investigational Site
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • GSK Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • GSK Investigational Site
    • East Melbourne, Victoria, Australia, 3002
      • GSK Investigational Site
    • Heidelberg, Victoria, Australia, 3084
      • GSK Investigational Site
    • Parkville, Victoria, Australia, 3050
      • GSK Investigational Site
• Belgium
  • Antwerpen, Belgium, 2060
    • GSK Investigational Site
  • Brugge, Belgium, 8000
    • GSK Investigational Site
  • Bruxelles, Belgium, 1000
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Hasselt, Belgium, 3500
    • GSK Investigational Site
  • Jette, Belgium, 1090
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Liege, Belgium, 4000
    • GSK Investigational Site
• Bulgaria
  • Sofia, Bulgaria
    • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • GSK Investigational Site
    • Quebec City, Quebec, Canada, G1J 1Z4
      • GSK Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • GSK Investigational Site
• Czechia
  • Hradec Kralove, Czechia
    • GSK Investigational Site
  • Olomouc, Czechia, 775 20
    • GSK Investigational Site
  • Praha 10, Czechia, 100 34
    • GSK Investigational Site
  • Praha 2, Czechia, 128 08
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13419
    • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00029
    • GSK Investigational Site
  • Tampere, Finland, 33520
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Clermont-Ferrand Cedex 1, France, 63003
    • GSK Investigational Site
  • Créteil cedex, France, 94010
    • GSK Investigational Site
  • Grenoble cedex 9, France, 38043
    • GSK Investigational Site
  • Marseille cedex 9, France, 13273
    • GSK Investigational Site
  • Montpellier cedex 5, France, 34295
    • GSK Investigational Site
  • Pessac cedex, France, 33604
    • GSK Investigational Site
  • Rouen cedex 1, France, 76038
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 12351
    • GSK Investigational Site
  • Berlin, Germany, 12200
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • GSK Investigational Site
  • Bayern
    • Bayreuth, Bayern, Germany, 95445
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81545
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97080
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • GSK Investigational Site
    • Eschweiler, Nordrhein-Westfalen, Germany, 52249
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • GSK Investigational Site
    • Velbert, Nordrhein-Westfalen, Germany, 42551
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • GSK Investigational Site
• Greece
  • Athens, Greece, 151 23
    • GSK Investigational Site
  • Athens, Greece, 115 27
    • GSK Investigational Site
  • Athens, Greece, 11527
    • GSK Investigational Site
  • Athens, Greece, 106 76
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • GSK Investigational Site
  • Tuen Mun, Hong Kong
    • GSK Investigational Site
• Israel
  • Hafia, Israel, 31096
    • GSK Investigational Site
  • Jerusalem, Israel, 91120
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Cona (FE), Emilia-Romagna, Italy, 44124
      • GSK Investigational Site
    • Meldola (FC), Emilia-Romagna, Italy, 47014
      • GSK Investigational Site
    • Ravenna, Emilia-Romagna, Italy
      • GSK Investigational Site
    • Rimini, Emilia-Romagna, Italy, 47900
      • GSK Investigational Site
  • Friuli-Venezia-Giulia
    • Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
      • GSK Investigational Site
    • Udine, Friuli-Venezia-Giulia, Italy, 33100
      • GSK Investigational Site
  • Lombardia
    • Rozzano (MI), Lombardia, Italy, 20089
      • GSK Investigational Site
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 811-1395
    • GSK Investigational Site
  • Gunma, Japan, 377-0280
    • GSK Investigational Site
  • Hiroshima, Japan, 737-0023
    • GSK Investigational Site
  • Hiroshima, Japan, 739-0651
    • GSK Investigational Site
  • Hyogo, Japan, 650-0047
    • GSK Investigational Site
  • Kumamoto, Japan, 860-0008
    • GSK Investigational Site
  • Nagasaki, Japan, 856-8562
    • GSK Investigational Site
  • Niigata, Japan, 951-8566
    • GSK Investigational Site
  • Okayama, Japan, 700-8558
    • GSK Investigational Site
  • Okayama, Japan, 701-1192
    • GSK Investigational Site
  • Shizuoka, Japan, 411-8777
    • GSK Investigational Site
  • Tokyo, Japan, 113-8677
    • GSK Investigational Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 405-760
    • GSK Investigational Site
  • Jellanamdo, Korea, Republic of, 519-809
    • GSK Investigational Site
  • Jeonju, Korea, Republic of, 561-712
    • GSK Investigational Site
  • Kyunggi-do, Korea, Republic of, 410-769
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 120-752
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • GSK Investigational Site
• Malaysia
  • Kuala Lumpur, Malaysia, 56000
    • GSK Investigational Site
  • Selangor, Malaysia, 68000 Ampang
    • GSK Investigational Site
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • GSK Investigational Site
• New Zealand
  • Christchurch, New Zealand, 8011
    • GSK Investigational Site
  • Grafton, New Zealand, 1003
    • GSK Investigational Site
  • Wellington, New Zealand, 6021
    • GSK Investigational Site
• Panama
  • Panama, Panama
    • GSK Investigational Site
• Poland
  • Gliwice, Poland, 44-101
    • GSK Investigational Site
  • Krakow, Poland, 30510
    • GSK Investigational Site
  • Warszawa, Poland, 02-776
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 022328
    • GSK Investigational Site
  • Bucharest, Romania, 030171
    • GSK Investigational Site
  • Tirgu Mures, Romania, 540042
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 105 229
    • GSK Investigational Site
  • Moscow, Russian Federation, 125101
    • GSK Investigational Site
  • Novosibirsk, Russian Federation, 630099
    • GSK Investigational Site
  • Petrozavodsk, Russian Federation, 185019
    • GSK Investigational Site
  • St'Petersburg, Russian Federation, 191024
    • GSK Investigational Site
  • St.-Petersburg, Russian Federation, 194291
    • GSK Investigational Site
  • St.Petersburg, Russian Federation, 197110
    • GSK Investigational Site
• South Africa
  • Groenkloof, South Africa, 0181
    • GSK Investigational Site
  • Moreleta Park, Pretoria, South Africa, 0001
    • GSK Investigational Site
  • Gauteng
    • Parktown, Gauteng, South Africa, 2193
      • GSK Investigational Site
  • Western Province
    • Plumstead, Western Province, South Africa
      • GSK Investigational Site
• Spain
  • Badalona/Barcelona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • La Coruña, Spain, 15006
    • GSK Investigational Site
  • León, Spain, 24008
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28009
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28033
    • GSK Investigational Site
  • Madrid, Spain
    • GSK Investigational Site
  • Madrid, Spain, 28050
    • GSK Investigational Site
  • Madrid, Spain, 28911
    • GSK Investigational Site
  • Majadahonda (Madrid), Spain, 28222
    • GSK Investigational Site
  • Malaga, Spain, 29010
    • GSK Investigational Site
  • Murcia, Spain, 30008
    • GSK Investigational Site
  • Murcia (El Palmar), Spain, 30120
    • GSK Investigational Site
  • Oviedo, Spain, 33006
    • GSK Investigational Site
  • Pozuelo De Alarcón/Madrid, Spain, 28223
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • Santander, Spain, 39008
    • GSK Investigational Site
  • Valencia, Spain, 46026
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
• Taiwan
  • Kaohsiung, Taiwan, 833
    • GSK Investigational Site
  • Taichung, Taiwan, 404
    • GSK Investigational Site
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
  • Taoyuan Hsien, Taiwan, 333
    • GSK Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • GSK Investigational Site
  • Ankara, Turkey, 06500
    • GSK Investigational Site
  • Ankara, Turkey
    • GSK Investigational Site
  • Istanbul, Turkey, 34481
    • GSK Investigational Site
  • Izmir, Turkey
    • GSK Investigational Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • GSK Investigational Site
  • Cottingham, United Kingdom, HU16 5JQ
    • GSK Investigational Site
  • Headington, Oxford, United Kingdom, OX3 7LE
    • GSK Investigational Site
  • Leeds, United Kingdom, LS9 7TF
    • GSK Investigational Site
  • Manchester, United Kingdom, M13 9WL
    • GSK Investigational Site
  • Manchester, United Kingdom, M20 4BX
    • GSK Investigational Site
  • Lanarkshire
    • Airdrie, Lanarkshire, United Kingdom, ML6 0JS
      • GSK Investigational Site
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BB
      • GSK Investigational Site
• United States
  • California
    • Duarte, California, United States, 91010
      • GSK Investigational Site
    • San Francisco, California, United States, 94143
      • GSK Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • GSK Investigational Site
  • Kansas
    • Westwood, Kansas, United States, 66205
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • GSK Investigational Site
    • Boston, Massachusetts, United States, 02111
      • GSK Investigational Site
    • Boston, Massachusetts, United States, 02115
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
  • Minnesota
    • Minnesota, Minnesota, United States, 55455
      • GSK Investigational Site
    • Rochester, Minnesota, United States, 55905
      • GSK Investigational Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10021
      • GSK Investigational Site
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27705
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98108
      • GSK Investigational Site
    • Seattle, Washington, United States, 98109-1024
      • GSK Investigational Site
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK1437173A Group; Subjects received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.	Biological: Herpes Zoster vaccine GSK1437173A; 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
Placebo Comparator: Placebo Group; Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.	Biological: Placebo; 2 doses administered IM in deltoid region of non-dominant arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Confirmed Herpes Zoster (HZ) Episode	A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings* suggestive of VZV infection in the absence of characteristic HZ or VZV rash. A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.	From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the 30-day (Days 0-29) post-vaccination period
Duration of 'Worst' HZ-associated Pain	Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].	From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
Number of Subjects With Confirmed HZ-associated Complications	This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.	From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Number of Subjects With Postherpetic Neuralgia (PHN)	This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.	From Month 0 until study end (21 months median follow-up)
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects	Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.	At Months 0, 1, 2, 13 and 25
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.	From Month 0 up to 365 days post last vaccination
Number of Subjects With Any Relapse	Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.	From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.	From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: JAMA. 2019 Aug 27;322(8):785.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2012
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Immunogenicity; Vaccination; Herpes Zoster; Observer-blind; Adult autologous haematopoietic cell transplant recipients
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex
• Other Study ID Numbers: 115523; 2012-000138-20 (EudraCT Number)