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

NCT01610414 | Completed Phase 3 Results

• 2 other identifiers: 1155232012-000138-20
• Study Type: interventional
• Target: 1,877
• Locations: 27 countries
• Sites: 154

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.

Conditions

Herpes Zoster

Keywords

Observer-blind; Efficacy; Immunogenicity; Vaccination; Safety; Adult autologous haematopoietic cell transplant recipients; Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Duration of 'Worst' HZ-associated Pain

  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

  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)

  From Month 0 until study end (21 months median follow-up)

• Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects

  At Months 0, 1, 2, 13 and 25

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Study Arms (2)

GSK1437173A Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Herpes Zoster vaccine GSK1437173A BIOLOGICAL

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

GSK1437173A Group

Placebo BIOLOGICAL

2 doses administered IM in deltoid region of non-dominant arm

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (178)

GSK Investigational Site

Duarte, California, 91010, United States

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GSK Investigational Site

San Francisco, California, 94143, United States

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GSK Investigational Site

Aurora, Colorado, 80045, United States

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GSK Investigational Site

Westwood, Kansas, 66205, United States

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Lexington, Kentucky, 40536, United States

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GSK Investigational Site

Boston, Massachusetts, 02111, United States

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GSK Investigational Site

Boston, Massachusetts, 02114, United States

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GSK Investigational Site

Boston, Massachusetts, 02115, United States

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GSK Investigational Site

Detroit, Michigan, 48201, United States

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Minneota, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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GSK Investigational Site

Hackensack, New Jersey, 07601, United States

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GSK Investigational Site

New York, New York, 10021, United States

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Syracuse, New York, 13210, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

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Durham, North Carolina, 27705, United States

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Cleveland, Ohio, 44195, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Seattle, Washington, 98108, United States

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Seattle, Washington, 98109-1024, United States

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Marshfield, Wisconsin, 54449, United States

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Darlinghurst, New South Wales, 2010, Australia

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Waratah, New South Wales, 2298, Australia

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Westmead, New South Wales, 2145, Australia

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Woodville, South Australia, 5011, Australia

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Hobart, Tasmania, 7000, Australia

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Box Hill, Victoria, 3128, Australia

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East Melbourne, Victoria, 3002, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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GSK Investigational Site

Antwerp, 2060, Belgium

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Bruges, 8000, Belgium

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Brussels, 1000, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Jette, 1090, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Sofia, Bulgaria

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Vancouver, British Columbia, V5Z 1M9, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Hradec Králové, Czechia

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Olomouc, 775 20, Czechia

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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GSK Investigational Site

Tallinn, 13419, Estonia

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Helsinki, 00029, Finland

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Tampere, 33520, Finland

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Turku, 20520, Finland

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GSK Investigational Site

Clermont-Ferrand, 63003, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Marseille, 13273, France

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Montpellier, 34295, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Rouen, 76038, France

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Bayreuth, Bavaria, 95445, Germany

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Munich, Bavaria, 81545, Germany

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Würzburg, Bavaria, 97080, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Eschweiler, North Rhine-Westphalia, 52249, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Velbert, North Rhine-Westphalia, 42551, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Berlin, 10117, Germany

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Berlin, 12200, Germany

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Berlin, 12351, Germany

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Athens, 106 76, Greece

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Athens, 115 27, Greece

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Athens, 11527, Greece

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Athens, 151 23, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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Hong Kong, Hong Kong

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GSK Investigational Site

Tuenmen, Hong Kong

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GSK Investigational Site

Hafia, 31096, Israel

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Jerusalem, 91120, Israel

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Cona (FE), Emilia-Romagna, 44124, Italy

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Meldola (FC), Emilia-Romagna, 47014, Italy

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Ravenna, Emilia-Romagna, Italy

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Rimini, Emilia-Romagna, 47900, Italy

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Aviano (PN), Friuli Venezia Giulia, 33081, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Rozzano (MI), Lombardy, 20089, Italy

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Novara, Piedmont, 28100, Italy

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GSK Investigational Site

Fukuoka, 811-1395, Japan

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Gunma, 377-0280, Japan

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Hiroshima, 737-0023, Japan

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Hiroshima, 739-0651, Japan

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Hyōgo, 650-0047, Japan

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Kumamoto, 860-0008, Japan

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Nagasaki, 856-8562, Japan

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Niigata, 951-8566, Japan

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Okayama, 700-8558, Japan

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Okayama, 701-1192, Japan

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Shizuoka, 411-8777, Japan

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Tokyo, 113-8677, Japan

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Kuala Lumpur, 56000, Malaysia

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Kuala Selangor, 68000 Ampang, Malaysia

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Leiden, 2333 ZA, Netherlands

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Christchurch, 8011, New Zealand

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Grafton, 1003, New Zealand

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Wellington, 6021, New Zealand

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Panama City, Panama

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Gliwice, 44-101, Poland

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Krakow, 30510, Poland

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Warsaw, 02-776, Poland

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Bucharest, 022328, Romania

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Bucharest, 030171, Romania

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GSK Investigational Site

Târgu Mureş, 540042, Romania

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GSK Investigational Site

Moscow, 105 229, Russia

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Moscow, 125101, Russia

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Novosibirsk, 630099, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 197110, Russia

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St'Petersburg, 191024, Russia

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Parktown, Gauteng, 2193, South Africa

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Plumstead, Western Province, South Africa

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Groenkloof, 0181, South Africa

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Moreleta Park, Pretoria, 0001, South Africa

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Daegu, 700-721, South Korea

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Incheon, 405-760, South Korea

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Jellanamdo, 519-809, South Korea

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Jeonju, 561-712, South Korea

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Kyunggi-do, 410-769, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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GSK Investigational Site

A Coruña, 15006, Spain

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Badalona/Barcelona, 08916, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

León, 24008, Spain

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GSK Investigational Site

Madrid, 28009, Spain

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GSK Investigational Site

Madrid, 28033, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28050, Spain

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GSK Investigational Site

Madrid, 28911, Spain

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Madrid, Spain

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GSK Investigational Site

Majadahonda (Madrid), 28222, Spain

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Málaga, 29010, Spain

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Murcia, 30008, Spain

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GSK Investigational Site

Murcia (El Palmar), 30120, Spain

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GSK Investigational Site

Oviedo, 33006, Spain

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Pozuelo de Alarcón/Madrid, 28223, Spain

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San Sebastián, 20014, Spain

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Santander, 39008, Spain

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Valencia, 46010, Spain

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Valencia, 46026, Spain

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

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Taichung, 40705, Taiwan

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GSK Investigational Site

Taoyuan Hsien, 333, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06500, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, 34481, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Airdrie, Lanarkshire, ML6 0JS, United Kingdom

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Swindon, Wiltshire, SN3 6BB, United Kingdom

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Bournemouth, BH7 7DW, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Headington, Oxford, OX3 7LE, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Related Publications (4)

• Matthews S, Curran D, Sabater Cabrera E, Boutry C, Lecrenier N, Cunningham AL, Schmader K. An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies. Clin J Pain. 2023 Aug 1;39(8):386-393. doi: 10.1097/AJP.0000000000001129.

  PMID: 37166199 DERIVED

• Kim JH, Johnson R, Kovac M, Cunningham AL, Amakrane M, Sullivan KM, Dagnew AF, Curran D, Schuind A. Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials. Pain. 2023 Apr 1;164(4):741-748. doi: 10.1097/j.pain.0000000000002760. Epub 2022 Aug 19.

  PMID: 36066965 DERIVED

• 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.

  PMID: 31394276 DERIVED

• 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.

  PMID: 31287523 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: July 13, 2012
• Primary Completion: November 4, 2016
• Study Completion: February 1, 2017
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

RU (7); JP (12); BE (8); KR (9); NL (1); ES (1); TW (4); NZ (3); PL (3); GB (8); GR (5); HK (2); US (23); BU (1); FR (7); DE (13); CZ (4); FI (3); IT (8); CA (6); IL (2); MY (2); ZA (4); TU (5); PA (1); AU (9); RO (3)