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

NCT01767467 | Completed Phase 3 Results

• 2 other identifiers: 1164282012-003438-18
• Study Type: interventional
• Target: 568
• Locations: 20 countries
• Sites: 85

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.

Conditions

Herpes Zoster

Keywords

Immunogenicity; Safety; Herpes zoster; Vaccination; Haematologic malignancies

Outcome Measures

Primary Outcomes (9)

• Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations

  Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE \[4x97 milli-international units per milliliter (mIU/mL)\]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

  At Month 2

• Adjusted Geometric Mean Concentration of Anti-gE Antibodies

  The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

  At Month 2

• 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 Days With Solicited Local Symptoms

  Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.

  Within the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °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 Days With Solicited General Symptoms

  Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.

  Withing the 7-day (Day 0-6) post-vaccination period

• 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. It also included 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.

  Within the 30-day (Days 0-29) post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination

  From first vaccination up to 30 days post last vaccination

• Number of Subjects Reporting 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. Related = pIMds assessed by the investigator as causally related to the study vaccination

  From first vaccination up to 30 days post last vaccination

Secondary Outcomes (11)

• Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations

  At Month 2

• Anti-gE Antibody Concentrations

  At Month 2

• Time to Occurrence of Any Confirmed HZ Case

  From Month 0 until study end (Month 13)

• Anti-gE Antibody Concentrations

  At Months 0, 1, 2 and 13

• Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations

  At Months 1, 2 and 13

Study Arms (2)

Vaccine Group

EXPERIMENTAL

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

Biological: Herpes zoster vaccine (GSK 1437173A)

Placebo Group

PLACEBO COMPARATOR

Subjects will receive the placebo vaccine.

Drug: Placebo

Interventions

Herpes zoster vaccine (GSK 1437173A) 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.

Vaccine Group

Placebo 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.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (86)

GSK Investigational Site

Inverness, Florida, 34452, United States

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GSK Investigational Site

Chicago, Illinois, 60637, United States

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GSK Investigational Site

Elkhart, Indiana, 46514, United States

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GSK Investigational Site

Boston, Massachusetts, 02115, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

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GSK Investigational Site

Seattle, Washington, 98108, United States

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GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

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GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Hobart, Tasmania, 7000, Australia

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GSK Investigational Site

Coburg, Victoria, 3058, Australia

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GSK Investigational Site

Wodonga, Victoria, 3690, Australia

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GSK Investigational Site

Antwerp, 2060, Belgium

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GSK Investigational Site

Bruges, 8000, Belgium

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GSK Investigational Site

Brussels, 1000, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Hasselt, 3500, Belgium

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GSK Investigational Site

Jette, 1090, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Saint John, New Brunswick, E2L 4L2, Canada

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GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

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GSK Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

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GSK Investigational Site

Toronto, Ontario, M4C 3E7, Canada

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GSK Investigational Site

Prague, 128 08, Czechia

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GSK Investigational Site

Helsinki, 00029, Finland

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GSK Investigational Site

Tampere, 33520, Finland

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Mulhouse, 68070, France

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GSK Investigational Site

Nantes, 44093, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Périgueux, 24019, France

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GSK Investigational Site

Rouen, 76038, France

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GSK Investigational Site

Hong Kong, Hong Kong

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GSK Investigational Site

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

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GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

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GSK Investigational Site

Novara, Piedmont, 28100, Italy

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GSK Investigational Site

Christchurch, 8011, New Zealand

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GSK Investigational Site

Hamilton, 3240, New Zealand

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GSK Investigational Site

Lahore, Pakistan

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GSK Investigational Site

Multan, Pakistan

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GSK Investigational Site

Panama City, Panama

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GSK Investigational Site

Chorzów, 41-500, Poland

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GSK Investigational Site

Opole, 45-372, Poland

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GSK Investigational Site

Słupsk, 76-200, Poland

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GSK Investigational Site

Nizhny Novgorod, 603126, Russia

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GSK Investigational Site

Petrozavodsk, 185019, Russia

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GSK Investigational Site

Saint Petersburg, 197 089, Russia

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GSK Investigational Site

Saint Petersburg, 197758, Russia

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GSK Investigational Site

St'Petersburg, 191024, Russia

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GSK Investigational Site

Yekaterinburg, 620102, Russia

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GSK Investigational Site

Singapore, 169608, Singapore

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GSK Investigational Site

Busan, 614-735, South Korea

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GSK Investigational Site

Daegu, 700-721, South Korea

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GSK Investigational Site

Incheon, 405-760, South Korea

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GSK Investigational Site

Jellanamdo, 519-809, South Korea

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GSK Investigational Site

Jeonju, 561-712, South Korea

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GSK Investigational Site

Kyunggi-do, 410-769, South Korea

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GSK Investigational Site

Seoul, 110-744, South Korea

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GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 137-701, South Korea

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GSK Investigational Site

Móstoles, Madrid, 28933, Spain

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GSK Investigational Site

Barcelona, 08035, 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, 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

Majadahonda (Madrid), 28222, Spain

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GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28223, Spain

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GSK Investigational Site

Santander, 39008, Spain

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GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

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GSK Investigational Site

Karlskrona, SE-371 41, Sweden

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GSK Investigational Site

Malmo, SE-205 02, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Kaohsiung City, 833, Taiwan

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GSK Investigational Site

Taichung, 404, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

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GSK Investigational Site

Taoyuan Hsien, 333, Taiwan

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GSK Investigational Site

Ankara, 06500, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06590, Turkey (Türkiye)

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GSK Investigational Site

Orpington, Kent, BR6 8ND, United Kingdom

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GSK Investigational Site

Airdrie, Lanarkshire, ML6 0JS, United Kingdom

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GSK Investigational Site

Swindon, Wiltshire, SN3 6BB, United Kingdom

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GSK Investigational Site

Bournemouth, BH7 7DW, United Kingdom

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GSK Investigational Site

Headington, Oxford, OX3 7LE, United Kingdom

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GSK Investigational Site

London, SE13 6LH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40396505 DERIVED

• 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.

  PMID: 31399377 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: March 1, 2013
• Primary Completion: January 7, 2016
• Study Completion: January 6, 2017
• Last Updated: June 6, 2018
• Results First Posted: May 25, 2017

Record last verified: 2018-05

Locations

GB (6); FI (2); SG (1); RU (6); CZ (1); FR (6); HK (1); TW (4); ES (10); KR (9); US (8); CA (4); TU (2); PL (3); PA (2); AU (4); BE (7); IT (3); NZ (2); SE (4)