Phase 3
Completed N=1,846
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
Source: ClinicalTrials.gov NCT01610414 ↗Enrolled (actual)
1,846
Serious AEs
34.6%
Results posted
Jan 2018
Primary outcomePrimary: Number of Subjects With Confirmed Herpes Zoster (HZ) Episode — 49; 135 Participants — p=<0.0001
◆ Published Evidence
Highly cited
257citations · ~37 / year
Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.
Summary
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
Linked Publications (4)
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Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.
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Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT).
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Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials.
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An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Confirmed Herpes Zoster (HZ) Episode |
49; 135 | <0.0001 sig |
| SECONDARY Duration of 'Worst' HZ-associated Pain |
892.0; 6275.0 | — |
| SECONDARY Number of Subjects With Confirmed HZ-associated Complications |
3; 13 | — |
| SECONDARY Number of Subjects With Postherpetic Neuralgia (PHN) |
1; 9 | — |
| SECONDARY Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects |
762.8; 555.0; 1844.2; 556.6; 12753.2; 443.8 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
688; 56; 59; 3; 187; 5 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
356; 282; 30; 16; 124; 55 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
360; 353; 60; 47; 31; 23 | — |
| SECONDARY Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) |
13; 8; 3; 0 | — |
| SECONDARY Number of Subjects With Any Relapse |
239; 253 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo |
263; 241; 3; 4; 329; 310 | — |
| SECONDARY Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination |
118; 124; 0; 37; 43; 0 | — |
Eligibility Criteria
Inclusion Criteria
Study entry (enrollment) occurs at the Pre-vaccination visit.
- 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.
- Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
- Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, 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 12 months after completion of the vaccination series (i.e., until Month 13).
Exclusion Criteria
- 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 or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
- Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
- Planned administration during the study of a HZ 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
- Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
- Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
- HIV infection by clinical history.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
Data sourced from ClinicalTrials.gov (NCT01610414) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.