Last updated: 07/17/2024 16:46:37

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

GSK study ID
116428
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Vaccine response rates (VRR) for anti-glycoprotein E (anti-gE) antibody concentrations

Timeframe: At Month 2

Adjusted geometric mean concentration of anti-gE antibodies

Timeframe: At Month 2

Number of subjects with any and Grade 3 solicited local symptoms

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

Number of days with solicited local symptoms

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

Number of subjects with any, Grade 3 and related solicited general symptoms

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

Number of days with solicited general symptoms

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

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

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

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination up to 30 days post last vaccination

Number of subjects reporting any and related potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination up to 30 days post last vaccination

Secondary outcomes:

Vaccine response rate (VRR) for anti-gE antibody concentrations

Timeframe: At Month 2

Anti-gE antibody concentrations

Timeframe: At Month 2

Time to occurrence of any confirmed HZ case

Timeframe: From Month 0 until study end (Month 13)

Anti-gE antibody concentrations

Timeframe: At Months 0, 1, 2 and 13

Vaccine response rate (VRR) for anti-gE antibody concentrations

Timeframe: At Months 1, 2 and 13

Frequency of gE -specific cluster of differentiation 4 (CD4) [2+] T-cells expressing at least 2 activation markers

Timeframe: At Months 0, 1, 2 and 13

Vaccine response rates (VRR) for gE-specific CD4 [2+] T-cells, expressing at least 2 activation markers

Timeframe: At Months 1, 2 and 13

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination at Month 0 up to study end at Month 13

Number of subjects reporting any potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination at Month 0 up to study end at Month 13

Geometric mean concentrations (GMCs) of anti-gE antibodies

Timeframe: At Months 0 and 2

Mean Geometric Increase (MGI) of anti-gE antibody ELISA concentrations

Timeframe: At Month 2

Interventions:
Biological/vaccine: Herpes zoster vaccine (GSK 1437173A)
Drug: Placebo
Enrollment:
567
Observational study model:
Not applicable
Primary completion date:
2016-07-01
Time perspective:
Not applicable
Clinical publications:
Dagnew AF et al. (2019) 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. 19(9):988-1000.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
March 2013 to January 2017
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
Status
Study Complete
Location
GSK Investigational Site
Ankara, Turkey, 06500
Status
Study Complete
Location
GSK Investigational Site
Ankara, Turkey, 06590
Status
Study Complete
Location
GSK Investigational Site
Antwerpen, Belgium, 2060
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
Location
GSK Investigational Site
Bournemouth, United Kingdom, BH7 7DW
Status
Study Complete
Location
GSK Investigational Site
Brugge, Belgium, 8000
Status
Study Complete
Location
GSK Investigational Site
Bruxelles, Belgium, 1000
Status
Study Complete
Location
GSK Investigational Site
Busan, South Korea, 614-735
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Chorzow, Poland, 41-500
Status
Study Complete
Location
GSK Investigational Site
Christchurch, New Zealand, 8011
Status
Study Complete
Location
GSK Investigational Site
Coburg, Victoria, Australia, 3058
Status
Study Complete
Location
GSK Investigational Site
Daegu, South Korea, 700-721
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Location
GSK Investigational Site
ESKILSTUNA, Sweden, SE-631 88
Status
Study Complete
Location
GSK Investigational Site
Ekaterinburg, Russia, 620102
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Status
Study Complete
Location
GSK Investigational Site
Hamilton, New Zealand, 3240
Status
Study Complete
Location
GSK Investigational Site
Hasselt, Belgium, 3500
Status
Study Complete
Location
GSK Investigational Site
Headington, Oxford, United Kingdom, OX3 7LE
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00029
Status
Study Complete
Location
GSK Investigational Site
Hobart, Tasmania, Australia, 7000
Status
Study Complete
Location
GSK Investigational Site
Hong Kong, Hong Kong
Status
Study Complete
Location
GSK Investigational Site
Incheon, South Korea, 405-760
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
Jellanamdo, South Korea, 519-809
Status
Study Complete
Location
GSK Investigational Site
Jeonju, South Korea, 561-712
Status
Study Complete
Location
GSK Investigational Site
KARLSKRONA, Sweden, SE-371 41
Status
Study Complete
Location
GSK Investigational Site
Kaohsiung, Taiwan, 833
Status
Study Complete
Location
GSK Investigational Site
Kyunggi-do, South Korea, 410-769
Status
Study Complete
Location
GSK Investigational Site
Lahore, Pakistan
Status
Study Complete
Location
GSK Investigational Site
London, United Kingdom, SE13 6LH
Status
Study Complete
Location
GSK Investigational Site
MALMÖ, Sweden, SE-205 02
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28009
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28033
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28041
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28050
Status
Study Complete
Location
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
Status
Study Complete
Location
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy, 47014
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
Montpellier cedex 5, France, 34295
Status
Study Complete
Location
GSK Investigational Site
Mulhouse, France, 68070
Status
Study Complete
Location
GSK Investigational Site
Multan, Pakistan
Status
Study Complete
Location
GSK Investigational Site
Móstoles, Madrid, Spain, 28933
Status
Study Complete
Location
GSK Investigational Site
Nantes cedex 1, France, 44093
Status
Study Complete
Location
GSK Investigational Site
Nizhniy Novgorod, Russia, 603126
Status
Study Complete
Location
GSK Investigational Site
Novara, Piemonte, Italy, 28100
Status
Study Complete
Location
GSK Investigational Site
Opole, Poland, 45-372
Status
Study Complete
Location
GSK Investigational Site
Orpington, Kent, United Kingdom, BR6 8ND
Status
Study Complete
Location
GSK Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
Status
Study Complete
Location
GSK Investigational Site
Panama, Panama
Status
Study Complete
Location
GSK Investigational Site
Petrozavodsk, Russia, 185019
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Praha 2, Czech Republic, 128 08
Status
Study Complete
Location
GSK Investigational Site
Périgueux cedex, France, 24019
Status
Study Complete
Location
GSK Investigational Site
Rouen cedex 1, France, 76038
Status
Study Complete
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 4L2
Status
Study Complete
Location
GSK Investigational Site
Santander, Spain, 39008
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 135-710
Status
Study Complete
Location
GSK Investigational Site
Singapore, Singapore, 169608
Status
Study Complete
Location
GSK Investigational Site
Slupsk, Poland, 76-200
Status
Study Complete
Location
GSK Investigational Site
St'Petersburg, Russia, 191024
Status
Study Complete
Location
GSK Investigational Site
St-Petersburg, Russia, 197758
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Russia, 197 089
Status
Study Complete
Location
GSK Investigational Site
Swindon, Wiltshire, United Kingdom, SN3 6BB
Status
Study Complete
Location
GSK Investigational Site
Taichung, Taiwan, 404
Status
Study Complete
Location
GSK Investigational Site
Taipei, Taiwan, 112
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33520
Status
Study Complete
Location
GSK Investigational Site
Taoyuan Hsien, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4C 3E7
Status
Study Complete
Location
GSK Investigational Site
UPPSALA, Sweden, SE-751 85
Status
Study Complete
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Wodonga, Victoria, Australia, 3690
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2016-07-01
Actual study completion date
2017-06-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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