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Completed

NCT Number: NCT04091451

Safety and Immunogenicity Study 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) With a Prior Episode of Herpes Zoster

The purpose of this study was 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 had a previous episode of Herpes Zoster (HZ).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Barnaul, Russia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)

Biological

2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

Placebo

Drug

2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

Primary outcomes

  1. Incidence Rate of Confirmed Herpes Zoster (HZ) Cases

    Time frame: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)

    A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

Secondary outcomes

  1. Incidence Rate of Confirmed HZ Cases

    Time frame: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)

    A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included PCR and the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

  2. Number of Participants With Any and Grade 3 Solicited Administration Site Events

    Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

    Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.

  3. Duration in Days of Solicited Administration Site Events

    Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

    Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.

  4. Number of Participants With Any, Grade 3 and Related Solicited Systemic Events

    Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

    Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.

  5. Duration in Days of Solicited Systemic Events

    Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

    Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature >=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.

  6. Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Time frame: Within 30 days after each vaccination (occurring at Day 1 and Month 2)

    An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination.

  7. Number of Participants With Any and Related Serious Adverse Events (SAEs)

    Time frame: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.

  8. Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)

    Time frame: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

    pIMDs are defined as 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 the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.

  9. Number of Participants With Any and Related SAEs

    Time frame: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.

  10. Number of Participants With Any and Related pIMDs

    Time frame: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

    pIMDs are defined as 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 the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.

  11. Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine

    Time frame: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)

    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.

  12. Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)

    Time frame: At Month 2 and Month 3

    Vaccine response for anti-gE antibodies is defined as:

    • For initially seronegative participants, anti-gE antibody concentration at post-vaccination >= 4-fold the cut-off value for anti-gE [97 international units per liter (IU/L)].
    • For initially seropositive participants, anti-gE antibody concentration at post-vaccination >= 4-fold the pre-vaccination anti-gE antibody concentration.

  13. Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA

    Time frame: At Day 1, Month 2 and Month 3

    Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2019
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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