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

NCT ID: NCT01610414

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1877 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-13
• Study Completion Date: 2017-02-01

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Herpes Zoster vaccine GSK1437173A

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

Herpes Zoster vaccine GSK1437173A

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

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).

• 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

Duarte, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Westwood, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Minneota, Minnesota, United States

GSK Investigational Site

Rochester, Minnesota, United States

GSK Investigational Site

Hackensack, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

GSK Investigational Site

Darlinghurst, New South Wales, Australia

GSK Investigational Site

Waratah, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Woodville, South Australia, Australia

GSK Investigational Site

Hobart, Tasmania, Australia

GSK Investigational Site

Box Hill, Victoria, Australia

GSK Investigational Site

East Melbourne, Victoria, Australia

GSK Investigational Site

Heidelberg, Victoria, Australia

GSK Investigational Site

Parkville, Victoria, Australia

GSK Investigational Site

Antwerp, , Belgium

GSK Investigational Site

Bruges, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Hasselt, , Belgium

GSK Investigational Site

Jette, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Liège, , Belgium

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Saint John, New Brunswick, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Saskatoon, Saskatchewan, Canada

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Olomouc, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Clermont-Ferrand, , France

GSK Investigational Site

Créteil, , France

GSK Investigational Site

Grenoble, , France

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Pessac, , France

GSK Investigational Site

Rouen, , France

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Bayreuth, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

GSK Investigational Site

Eschweiler, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Velbert, North Rhine-Westphalia, Germany

GSK Investigational Site

Kiel, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Hong Kong, , Hong Kong

GSK Investigational Site

Tuenmen, , Hong Kong

GSK Investigational Site

Hafia, , Israel

GSK Investigational Site

Jerusalem, , Israel

GSK Investigational Site

Cona (FE), Emilia-Romagna, Italy

GSK Investigational Site

Meldola (FC), Emilia-Romagna, Italy

GSK Investigational Site

Ravenna, Emilia-Romagna, Italy

GSK Investigational Site

Rimini, Emilia-Romagna, Italy

GSK Investigational Site

Aviano (PN), Friuli Venezia Giulia, Italy

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Rozzano (MI), Lombardy, Italy

GSK Investigational Site

Novara, Piedmont, Italy

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Gunma, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Nagasaki, , Japan

GSK Investigational Site

Niigata, , Japan

GSK Investigational Site

Okayama, , Japan

GSK Investigational Site

Okayama, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Kuala Lumpur, , Malaysia

GSK Investigational Site

Kuala Selangor, , Malaysia

GSK Investigational Site

Leiden, , Netherlands

GSK Investigational Site

Christchurch, , New Zealand

GSK Investigational Site

Grafton, , New Zealand

GSK Investigational Site

Wellington, , New Zealand

GSK Investigational Site

Panama City, , Panama

GSK Investigational Site

Gliwice, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Târgu Mureş, , Romania

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Petrozavodsk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Parktown, Gauteng, South Africa

GSK Investigational Site

Plumstead, Western Province, South Africa

GSK Investigational Site

Groenkloof, , South Africa

GSK Investigational Site

Moreleta Park, Pretoria, , South Africa

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Jellanamdo, , South Korea

GSK Investigational Site

Jeonju, , South Korea

GSK Investigational Site

Kyunggi-do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

A Coruña, , Spain

GSK Investigational Site

Badalona/Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

León, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Majadahonda (Madrid), , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Murcia, , Spain

GSK Investigational Site

Murcia (El Palmar), , Spain

GSK Investigational Site

Oviedo, , Spain

GSK Investigational Site

Pozuelo de Alarcón/Madrid, , Spain

GSK Investigational Site

San Sebastián, , Spain

GSK Investigational Site

Santander, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taoyuan Hsien, , Taiwan

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Istanbul, , Turkey (Türkiye)

GSK Investigational Site

Izmir, , Turkey (Türkiye)

GSK Investigational Site

Airdrie, Lanarkshire, United Kingdom

GSK Investigational Site

Swindon, Wiltshire, United Kingdom

GSK Investigational Site

Bournemouth, , United Kingdom

GSK Investigational Site

Cottingham, , United Kingdom

GSK Investigational Site

Headington, Oxford, , United Kingdom

GSK Investigational Site

Leeds, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

Countries

United States; Australia; Belgium; Bulgaria; Canada; Czechia; Estonia; Finland; France; Germany; Greece; Hong Kong; Israel; Italy; Japan; Malaysia; Netherlands; New Zealand; Panama; Poland; Romania; Russia; South Africa; South Korea; Spain; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37166199 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36066965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31394276 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31287523 (View on PubMed)

Other Identifiers

2012-000138-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

115523

Identifier Type: -

Identifier Source: org_study_id