Herpes ZosterPhase 3NCT01767467
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
A Phase 3 study testing Herpes zoster vaccine (GSK 1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 86 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Herpes zoster vaccine (GSK 1437173A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 568 participants
- Where
- 86 sitesin 21 countries
- Study dates
- 1 Mar 2013to 6 Jan 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
86 sites in 21 countries.
86 sites in 21 countries
Spain10 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Madrid, 28009
GSK Investigational Site
Madrid, 28033
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28050
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Móstoles, Madrid, 28933
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Santander, 39008
South Korea9 sites
GSK Investigational Site
Busan, 614-735
GSK Investigational Site
Daegu, 700-721
GSK Investigational Site
Incheon, 405-760
GSK Investigational Site
Jellanamdo, 519-809
GSK Investigational Site
Jeonju, 561-712
GSK Investigational Site
Kyunggi-do, 410-769
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 137-701
United States8 sites
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Elkhart, Indiana, 46514
GSK Investigational Site
Inverness, Florida, 34452
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Seattle, Washington, 98108
Belgium7 sites
GSK Investigational Site
Antwerp, 2060
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Jette, 1090
GSK Investigational Site
Leuven, 3000
France6 sites
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Mulhouse, 68070
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Périgueux, 24019
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Rouen, 76038
Russia6 sites
GSK Investigational Site
Nizhny Novgorod, 603126
GSK Investigational Site
Petrozavodsk, 185019
GSK Investigational Site
Saint Petersburg, 197 089
GSK Investigational Site
Saint Petersburg, 197758
GSK Investigational Site
St'Petersburg, 191024
GSK Investigational Site
Yekaterinburg, 620102
United Kingdom6 sites
GSK Investigational Site
Airdrie, Lanarkshire, ML6 0JS
GSK Investigational Site
Bournemouth, BH7 7DW
GSK Investigational Site
Headington, Oxford, OX3 7LE
GSK Investigational Site
London, SE13 6LH
GSK Investigational Site
Orpington, Kent, BR6 8ND
GSK Investigational Site
Swindon, Wiltshire, SN3 6BB
Australia4 sites
GSK Investigational Site
Coburg, Victoria, 3058
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Hobart, Tasmania, 7000
GSK Investigational Site
Wodonga, Victoria, 3690
Canada4 sites
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Oshawa, Ontario, L1G 2B9
GSK Investigational Site
Saint John, New Brunswick, E2L 4L2
GSK Investigational Site
Toronto, Ontario, M4C 3E7
Sweden4 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Malmö, SE-205 02
GSK Investigational Site
Uppsala, SE-751 85
Taiwan4 sites
GSK Investigational Site
Kaohsiung City, 833
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Taoyuan Hsien, 333
Italy3 sites
GSK Investigational Site
Meldola (FC), Emilia-Romagna, 47014
GSK Investigational Site
Novara, Piedmont, 28100
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100
Poland3 sites
GSK Investigational Site
Chorzów, 41-500
GSK Investigational Site
Opole, 45-372
GSK Investigational Site
Słupsk, 76-200
Finland2 sites
GSK Investigational Site
Helsinki, 00029
GSK Investigational Site
Tampere, 33520
New Zealand2 sites
GSK Investigational Site
Christchurch, 8011
GSK Investigational Site
Hamilton, 3240
Pakistan2 sites
GSK Investigational Site
Lahore
GSK Investigational Site
Multan
Turkey (Türkiye)2 sites
GSK Investigational Site
Ankara, 06500
GSK Investigational Site
Ankara, 06590
About this study
Official title: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
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.
Read the 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
- Being tested
- Herpes zoster vaccine (GSK 1437173A), Placebo
- Keywords
- Immunogenicity, Safety, Herpes zoster, Vaccination, Haematologic malignancies
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group | Experimental | Subjects will receive the candidate HZ vaccine (GSK 1437173A). Receives: Biological: Herpes zoster vaccine (GSK 1437173A) |
| Placebo Group | Placebo comparator | Subjects will receive the placebo vaccine. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From first vaccination up to 30 days post last vaccination
Secondary outcomes (11)
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 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.
Measured: At Month 2
Anti-gE Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Measured: At Month 2
Time to Occurrence of Any Confirmed HZ Case
Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination.
Any clinically suspected case of HZ (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 Varicella Zoster Virus (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.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.
Measured: From Month 0 until study end (Month 13)
Anti-gE Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.
Measured: At Months 0, 1, 2 and 13
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.
Measured: At Months 1, 2 and 13
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).
Measured: At Months 0, 1, 2 and 13
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as:
For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells).
For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Measured: At Months 1, 2 and 13
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
Measured: From first vaccination at Month 0 up to study end at Month 13
Number of Subjects Reporting Any 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
Measured: From first vaccination at Month 0 up to study end at Month 13
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).
Measured: At Months 0 and 2
Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.
Measured: At Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study start1 Mar 2013
- Primary completion7 Jan 2016
- Study completion6 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767467
- Sponsor's protocol ID
- 116428
- Other IDs
- 2012-003438-18
- Status last verified
- May 2018
- First submitted
- 10 Jan 2013
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 40396505Dagnew 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.
PubMed 31399377
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
- ClinicalTrials.gov ID
- NCT01767467
- Acronym / sponsor ID
- 116428
- Conditions
- Herpes Zoster
- Keywords
- Immunogenicity, Safety, Herpes zoster, Vaccination, Haematologic malignancies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2013
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | Experimental | Biological: Herpes zoster vaccine (GSK 1437173A)Subjects will receive the candidate HZ vaccine (GSK 1437173A). |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive the placebo vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Vaccine Group |
| Placebo2 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. | Drug | Placebo Group |
Primary outcome
Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
Time frame: At Month 2
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.
Adjusted Geometric Mean Concentration of Anti-gE Antibodies
Time frame: At Month 2
The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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.
Number of Days With Solicited Local Symptoms
Time frame: Within the 7-day (Days 0-6) post-vaccination period
Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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.
Number of Days With Solicited General Symptoms
Time frame: Withing the 7-day (Day 0-6) post-vaccination period
Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within the 30-day (Days 0-29) post-vaccination period
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.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From first vaccination up to 30 days post last vaccination
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
Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination up to 30 days post last vaccination
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
11 secondary outcomes
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Time frame: At Month 2
Anti-gE Antibody Concentrations
Time frame: At Month 2
Time to Occurrence of Any Confirmed HZ Case
Time frame: From Month 0 until study end (Month 13)
Anti-gE Antibody Concentrations
Time frame: At Months 0, 1, 2 and 13
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Time frame: At Months 1, 2 and 13
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
Time frame: At Months 0, 1, 2 and 13
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
Time frame: At Months 1, 2 and 13
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From first vaccination at Month 0 up to study end at Month 13
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination at Month 0 up to study end at Month 13
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
Time frame: At Months 0 and 2
Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
Time frame: At Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40396505Zorger 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.
- Derived from this study: PubMed 31399377Dagnew 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
86 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herpes zoster vaccine (GSK 1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 86 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in Spain, South Korea, United States, Belgium, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations (time frame: At Month 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.