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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 belowSelect...
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:Select...
I haven't received immunoglobulins or blood products 3 months before or won't until 26 months after the first study vaccine dose.
Select...
I have a condition that weakens my immune system.
Select...
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 weeks3 visits
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
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
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 moreSecondary 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 moreTrial 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
Shingrix for Herpes Zoster: A Review
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will not receive a live vaccine 30 days before or after the study vaccine doses.I haven't had a transplant rejection in the last 3 months.I am a woman who cannot become pregnant due to medical reasons.I plan to or have received a vaccine not part of the study within 8 days before or 30 days after getting the study vaccine.I had shingles within the last year.I haven't received immunoglobulins or blood products 3 months before or won't until 26 months after the first study vaccine dose.I am not planning to become pregnant or stop using birth control for 2 months after my second vaccine dose.I completed the 2-dose HZ/su vaccine course in the ZOSTER-041 study.I can follow the study's requirements or have someone who can ensure I do.I am a woman who can have children, used birth control for 30 days, tested negative for pregnancy today, and will continue birth control for 2 months after getting revaccinated.I have a condition that weakens my immune system.I haven't used B-cell antibodies for transplant rejection within 9 months.I have been vaccinated against shingles after completing study ZOSTER-041.I have had more than one organ transplant.I have been on CIS therapy to prevent organ rejection for at least a month.
Research Study Groups:
This trial has the following groups:- Group 1: HZ/su Group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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