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Herpes ZosterPhase 3NCT02075515

Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

A Phase 3 study testing Herpes Zoster vaccine (GSK 1437173A) in people with Herpes Zoster and Herpes Zoster Vaccine, run by GlaxoSmithKline at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster, Herpes Zoster Vaccine
What is being tested?
Herpes Zoster vaccine (GSK 1437173A)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
651 participants
Where
8 sitesin 3 countries
Study dates
13 Aug 2014to 25 Apr 2016
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female aged 50 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • 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 in the study, if the subject:
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  • 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

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
  • 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, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
  • Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
  • 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 product.
  • Previous vaccination against HZ or varicella.
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  • Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
  • History of HZ.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
  • 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 enrollment.
  • Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) on rectal route. The preferred route for recording temperature in this study will be oral.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating females.
  • Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States3 sites

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Milford, Massachusetts, 01757

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

Canada3 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

Belgium2 sites

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

About this study

Official title: Consistency, Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 50 Years of Age or Older

The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.

Being tested
Herpes Zoster vaccine (GSK 1437173A)
Keywords
Safety, Zoster, Immunogenicity, Adults, Consistency
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

    Also called HZ/su vaccine

    2 doses administered intramuscularly in deltoid region of non-dominant arm.

Study groups in NCT02075515
Study groupRoleWhat they receive
HZ/su Lot AExperimentalSubjects will receive Lot A of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Receives: Biological: Herpes Zoster vaccine (GSK 1437173A)
HZ/su Lot BExperimentalSubjects will receive Lot B of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Receives: Biological: Herpes Zoster vaccine (GSK 1437173A)
HZ/su Lot CExperimentalSubjects will receive Lot C of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot.
Receives: Biological: Herpes Zoster vaccine (GSK 1437173A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value

    Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).

    Measured: At Month 3

Secondary outcomes (9)

  1. Anti-gE Humoral Immunogenicity

    Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).

    Measured: At Month 0 and Month 3

  2. Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA

    Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

    Measured: At Month 3

  3. 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 = significant pain at rest, that prevented normal every day activities.

    Measured: Within 7 days (Days 0-6) after each vaccine dose and across doses

  4. Number of Days With Any Solicited Local Symptoms

    The number of days with any local symptoms reported during the solicited post-vaccination period.

    Measured: During the 7 days (Days 0-6) after each vaccine dose

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

    Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Measured: Within 7 days (Days 0-6) after each vaccine dose and across doses

  6. Number of Days With Any Solicited General Symptoms

    The number of days with any general symptoms reported during the solicited post-vaccination period.

    Measured: During the 7 days (Days 0-6) after each vaccine dose

  7. Number of Subjects With 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 up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)

  8. 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 and 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: During 30 days (Days 0-29) after each vaccination

  9. Number of Subjects With Any Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study start13 Aug 2014
  3. Primary completion29 Apr 2015
  4. Study completion25 Apr 2016

Resources

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, Investigator
Enrolment
651 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075515
Sponsor's protocol ID
117177
Other IDs
2013-000373-76
Status last verified
Apr 2021
First submitted
27 Feb 2014
Last updated
14 May 2021
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Strezova A, Godeaux O, Aggarwal N, Leroux-Roels G, Lopez-Fauqued M, Van Damme P, Vanden Abeele C, Vastiau I, Heineman TC, Lal H. A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine. 2017 Dec 4;35(48 Pt B):6700-6706. doi: 10.1016/j.vaccine.2017.10.017. Epub 2017 Oct 24.

    PubMed 29079101

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 and Herpes Zoster Vaccine, run by GlaxoSmithKline at 8 sites in 3 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 9 inclusion and 19 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada, Belgium. 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. 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 24 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?

Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value (time frame: At Month 3). 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 NCT02075515, which also lists 1 linked publication.

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 14 May 2021.

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