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Virus Vaccine

Herpes Zoster Vaccine for Shingles

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course.
Be older than 18 years old
Must not have
Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26).
Any additional confirmed or suspected immunosuppressive or immunodeficient condition.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from month 26 (1 month post-revaccination dose 2) up to month 49 (24 months post-revaccination dose 2) in the current zoster-073 study
Awards & highlights

Summary

This trial evaluates how well a shingles vaccine works and its safety over several years after initial vaccination. It also looks at immune responses and safety after giving two more doses several years later. Previous studies demonstrated the vaccine's effectiveness for a few years after vaccination.

Who is the study for?
Adult kidney transplant recipients who previously completed the HZ/su vaccine course in study ZOSTER-041, without recent organ rejection or other significant illnesses. Women must either be non-childbearing or use contraception and have a negative pregnancy test before revaccination.
What is being tested?
The trial is testing the long-term immune response to GSK's Herpes Zoster subunit vaccine in kidney transplant patients. It evaluates safety over 7 years post-initial vaccination and checks immune responses after two additional doses given 6-8 years later.
What are the potential side effects?
Potential side effects are not detailed but may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain, and potential risks specific to immunocompromised individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed the 2-dose HZ/su vaccine course in the ZOSTER-041 study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't received immunoglobulins or blood products 3 months before or won't until 26 months after the first study vaccine dose.
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I have a condition that weakens my immune system.
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I haven't used B-cell antibodies for transplant rejection within 9 months.
Select...
I have had more than one organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from month 26 (1 month post-revaccination dose 2) up to month 49 (24 months post-revaccination dose 2) in the current zoster-073 study
This trial's timeline: 3 weeks for screening, Varies for treatment, and from month 26 (1 month post-revaccination dose 2) up to month 49 (24 months post-revaccination dose 2) in the current zoster-073 study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anti-gE Antibody Concentrations at Month 24 (Pre-revaccination) in the Revaccination Active Phase of the Current ZOSTER-073 Study
Anti-gE Antibody Concentrations at Month 25 (1 Month Post-revaccination Dose 1) in the Revaccination Active Phase of the Current ZOSTER-073 Study
Anti-gE Antibody Concentrations at Month 26 (1 Month Post-revaccination Dose 2) in the Revaccination Active Phase of the Current ZOSTER-073 Study
+2 more
Secondary study objectives
Anti-gE Antibody Concentrations at Month 37 (12 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
Anti-gE Antibody Concentrations at Month 49 (24 Months Post-revaccination Dose 2) in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
Duration in Days of Solicited General Adverse Events (AEs) After Each Revaccination in the Revaccination Active Phase of the Current ZOSTER-073 Study
+28 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HZ/su GroupExperimental Treatment1 Intervention
Eligible adult participants with renal transplant taking daily chronic immunosuppressive therapy who had a complete 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Shingles include antiviral agents and vaccines. Antiviral agents like acyclovir, valacyclovir, and famciclovir inhibit viral replication, reducing the severity and duration of the infection. The Herpes Zoster subunit (HZ/su) vaccine, such as Shingrix®, stimulates the immune system to produce a strong immune response against the varicella-zoster virus, preventing its reactivation. This is crucial for Shingles patients as it not only lowers the risk of developing the disease but also helps prevent complications like post-herpetic neuralgia.
Shingrix for Herpes Zoster: A Review

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,794 Previous Clinical Trials
8,177,593 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,602 Previous Clinical Trials
6,144,816 Total Patients Enrolled

Media Library

HZ/su vaccine (GSK1437173A) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04176939 — Phase 3
Shingles Research Study Groups: HZ/su Group
Shingles Clinical Trial 2023: HZ/su vaccine (GSK1437173A) Highlights & Side Effects. Trial Name: NCT04176939 — Phase 3
HZ/su vaccine (GSK1437173A) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176939 — Phase 3
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