What side effects are associated with this type of intervention?

The most common treatments for shingles include antiviral medications and vaccines like the Herpes Zoster subunit (HZ/su) vaccine. The HZ/su vaccine, which stimulates the immune system to protect against shingles, has been shown to be generally safe. However, common side effects include injection site reactions (such as redness, swelling, and pain), muscle pain, fatigue, headache, shivering, fever, and gastrointestinal symptoms. These side effects are typically mild to moderate in intensity and resolve on their own.

What prior FDA approvals exist?

The FDA has approved two vaccines for the prevention of shingles (Herpes Zoster). Zostavax, a live attenuated vaccine, was the first to be approved and is recommended for individuals aged 60 and older. It reduces the risk of developing shingles and postherpetic neuralgia. Shingrix, a recombinant subunit vaccine, was later approved and is recommended for adults aged 50 and older. Shingrix has shown higher efficacy compared to Zostavax and provides strong protection by stimulating the immune system to protect against the virus. Both vaccines aim to reduce the incidence and severity of shingles and its complications.

What other types of research exist?

As of now, there are no specific novel alternatives to the Herpes Zoster subunit (HZ/su) vaccine that have been identified for 2024. The HZ/su vaccine (Shingrix®) remains the most effective and recommended option for shingles prevention. Research is ongoing in the field of herpes zoster vaccines, but no new candidates have been confirmed as viable alternatives yet. Patients should consult with their healthcare providers for the most current recommendations and any emerging treatments.

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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

No Placebo-Only Group

Pivotal Trial

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

Select...

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

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

Awards & Highlights

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.

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.

0 / 5Eligibility criteria met

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