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A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles

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ClinicalTrials.gov Identifier: NCT04091451
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who have had a previous episode of shingles.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) Drug: Placebo Phase 3

Detailed Description:
The study will be conducted in 2 epochs: Epoch 001- starting from visit day 1, followed by visit month 2 and then Visit 3 at one month post last vaccination (Month 3). Epoch 002- Starting with monthly contact after Visit 3 (Month 3) and ending at 26 months from the enrolment date.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit Vaccine (HZ/su) GSK1437173A on a Two-dose Schedule in Adults ≥ 50 Years of Age With a Prior Episode of Herpes Zoster
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: HZ/su Group
Subjects randomized to the HZ/su group will receive 2 doses of HZ/su vaccine at visit day 1 and visit month 2 and will be followed up until the study end.
Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
2 doses of the HZ/su vaccine in a 0,2 Months schedule, administered intramuscularly

Placebo Comparator: Placebo Group
Subjects randomized to Placebo group will receive placebo at visit day 1 and visit month 2 and will be followed up until the study end.
Drug: Placebo
2 doses of the placebo in a 0,2 Months schedule, administered intramuscularly




Primary Outcome Measures :
  1. Number of confirmed Herpes Zoster (HZ) cases [ Time Frame: From one-month post-dose 2 (i.e. Month 3) to study end (i.e. Month 26) ]
    A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC). The incidence of HZ recurrence in the HZ/su group versus placebo group is compared by performing a non-inferiority analysis.


Secondary Outcome Measures :
  1. Number of confirmed HZ cases [ Time Frame: From Visit Day 1 till study end (Month 26) ]
    A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways: - By PCR (Polymerase Chain Reaction). - By the HZ Ascertainment Committee (HZAC).

  2. Number of subjects with any solicited local adverse events (AEs) [ Time Frame: Within 7 days after each vaccination (Vaccines administered on Day 1 and Month 2) ]
    An AE is 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. Assessed solicited local AEs are pain, redness swelling and itching at the injection site. Any = occurrence of the AE regardless of intensity grade.

  3. Number of subjects with any solicited general adverse events (AEs) [ Time Frame: Within 7 days after each vaccination (Vaccines administered on Day 1 and Month 2) ]
    An AE is 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. Assessed solicited general AEs are fatigue, fever (defined as axillary temperature ≥ 38.0°C / 100.4°F), gastrointestinal symptoms, headache, myalgia, shivering and malaise. Any = occurrence of the AE regardless of intensity grade.

  4. Number of subjects with any unsolicited AEs [ Time Frame: Within 30 days after each vaccination (Vaccines administered on Day 1 and Month 2) ]
    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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  5. Number of subjects with any serious adverse events (SAEs) [ Time Frame: From Visit Day 1 up to 30 days post last vaccination (i.e. Month 3) ]
    SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.

  6. Number of subjects with any serious adverse events (SAEs) [ Time Frame: From 30 days post last vaccination (i.e. Month 3) to 1 year post last vaccination (i.e. Month 14) ]
    SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any= occurrence of SAE regardless of the relation to vaccination.

  7. Number of subjects with any related SAEs [ Time Frame: During the entire study period (Visit day 1 to Month 26) ]
    SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Related= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator.

  8. Number of subjects with any potential immune-mediated diseases (pIMDs). [ Time Frame: From Visit Day 1 up to 30 days post last vaccination (i.e. Month 3) ]
    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. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination.

  9. Number of subjects with any pIMDs. [ Time Frame: From 30 days post last vaccination (i.e. Month 3) to 1 year post last vaccination (i.e. Month 14) ]
    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. Any= occurrence of pIMD regardless of intensity grade and relationship to the vaccination

  10. Vaccine response rate (VRR) for anti-glycoprotein E (Anti-gE) antibodies as determined by Enzyme Linked Immunosorbent Assay (ELISA) [ Time Frame: At Month 2 and Month 3 ]
    VRR is defined as percentage of subjects who have at least: - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or, - A 4-fold increase in the post last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline.

  11. Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs) as determined by ELISA [ Time Frame: At Day 1, Month 2 and Month 3 ]
    The geometric mean concentration (GMC) calculations are performed by taking the antilog of the mean of the log concentration transformations.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
  • A male or female ≥ 50 YOA at the time of the first vaccination.
  • Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:

    • Clinically diagnosed HZ:

OR Laboratory diagnosed HZ: OR

  • HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause.

    • Female subjects of childbearing potential may be enrolled in the 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 for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
  • Chronic antiviral use for HZ prophylaxis.
  • History of >1 prior episode of HZ.
  • A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
  • Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
  • Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
  • Previous vaccination against VZV or HZ.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091451


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Estonia
GSK Investigational Site Recruiting
Tartu, Estonia, 50106
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Airi Poder         
Finland
GSK Investigational Site Recruiting
Helsinki, Finland, 00290
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Veli-Jukka Anttila         
GSK Investigational Site Recruiting
Jyvaskyla, Finland, 40100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jani Hayrinen         
United Kingdom
GSK Investigational Site Recruiting
Belfast, United Kingdom, BT7 2EB
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Damien McNally         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04091451     History of Changes
Other Study ID Numbers: 204939
2016-000744-34 ( EudraCT Number )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Shingles
Shingles recurrence
HZ
Vaccine response rate
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs