Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

NCT ID: NCT01767467

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2017-01-06

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Detailed Description

Amendment to protocol posting:

Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).

Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).

Conditions

Herpes Zoster

Study Design

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

Study Groups

Vaccine Group

Subjects will receive the candidate HZ vaccine (GSK 1437173A).

Group Type: EXPERIMENTAL

Herpes zoster vaccine (GSK 1437173A)

Intervention Type: BIOLOGICAL

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Placebo Group

Subjects will receive the placebo vaccine.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Interventions

Herpes zoster vaccine (GSK 1437173A)

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Intervention Type: BIOLOGICAL

Placebo

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
• Life expectancy greater than or equal to 12 months, as assessed by the investigator.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled inthe study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, 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 2 months after completion of the vaccination series.

Exclusion Criteria

• Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
• Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
• Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
• Human immunodeficiency virus (HIV) infection by clinical history.
• 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 product to treat the subject's 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 or varicella vaccine (including an investigational or non-registered 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 any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine.
• Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months 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

Inverness, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Elkhart, Indiana, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Chapel Hill, North Carolina, 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

Hobart, Tasmania, Australia

GSK Investigational Site

Coburg, Victoria, Australia

GSK Investigational Site

Wodonga, Victoria, Australia

GSK Investigational Site

Antwerp, , Belgium

GSK Investigational Site

Bruges, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Hasselt, , Belgium

GSK Investigational Site

Jette, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Saint John, New Brunswick, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Oshawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Mulhouse, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Pessac, , France

GSK Investigational Site

Périgueux, , France

GSK Investigational Site

Rouen, , France

GSK Investigational Site

Hong Kong, , Hong Kong

GSK Investigational Site

Meldola (FC), Emilia-Romagna, Italy

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Novara, Piedmont, Italy

GSK Investigational Site

Christchurch, , New Zealand

GSK Investigational Site

Hamilton, , New Zealand

GSK Investigational Site

Lahore, , Pakistan

GSK Investigational Site

Multan, , Pakistan

GSK Investigational Site

Panama City, , Panama

GSK Investigational Site

Chorzów, , Poland

GSK Investigational Site

Opole, , Poland

GSK Investigational Site

Słupsk, , Poland

GSK Investigational Site

Nizhny Novgorod, , 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

Yekaterinburg, , Russia

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Busan, , South Korea

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

Móstoles, Madrid, Spain

GSK Investigational Site

Barcelona, , 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

Pozuelo de Alarcón/Madrid, , Spain

GSK Investigational Site

Santander, , Spain

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan Hsien, , Taiwan

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Orpington, Kent, United Kingdom

GSK Investigational Site

Airdrie, Lanarkshire, United Kingdom

GSK Investigational Site

Swindon, Wiltshire, United Kingdom

GSK Investigational Site

Bournemouth, , United Kingdom

GSK Investigational Site

Headington, Oxford, , United Kingdom

GSK Investigational Site

London, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Czechia; Finland; France; Hong Kong; Italy; New Zealand; Pakistan; Panama; Poland; Russia; Singapore; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); United Kingdom

References

Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.

Reference Type: DERIVED

PMID: 40396505 (View on PubMed)

Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6.

Reference Type: DERIVED

PMID: 31399377 (View on PubMed)

Other Identifiers

2012-003438-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116428

Identifier Type: -

Identifier Source: org_study_id