What is the mechanism of action of this treatment?

The most common treatments for shingles include antiviral medications, such as acyclovir, valacyclovir, and famciclovir, which work by inhibiting viral replication, thereby reducing the severity and duration of the infection. Additionally, vaccines like the recombinant zoster vaccine (Shingrix) stimulate the immune system to recognize and fight the virus more effectively. The Varicella Zoster Virus modRNA vaccine under study aims to induce a robust immune response by using modified RNA to produce viral proteins that trigger immunity. This approach is significant for shingles patients as it could offer a more effective and longer-lasting protection against the virus, potentially reducing the incidence and severity of shingles outbreaks.

What side effects are associated with this type of intervention?

Common treatments for shingles include antiviral medications like valaciclovir, famciclovir, and acyclovir, which are generally well-tolerated but can cause side effects such as headache, nausea, and abdominal pain. The recombinant zoster vaccine, used to prevent shingles, can cause side effects including injection site reactions (pain, redness, swelling), muscle pain, fatigue, headache, shivering, fever, and gastrointestinal symptoms. These side effects are typically mild to moderate and resolve on their own.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of shingles (herpes zoster), including the live attenuated zoster vaccine (Zostavax) and the adjuvanted recombinant zoster vaccine (Shingrix). Shingrix, in particular, is notable for its use of a non-live, recombinant subunit approach to induce an immune response, which is somewhat similar to the concept of using modified RNA to stimulate immunity. These vaccines have been shown to be effective in reducing the incidence of shingles and its associated complications in older adults.

What other types of research exist?

Promising novel alternatives to Varicella Zoster Virus modRNA for shingles patients include: 1) Recombinant Zoster Vaccine (RZV), which has shown safety and efficacy in preventing herpes zoster, especially in immunocompromised populations. 2) Inactivated Varicella Zoster Vaccine (ZVIN), which has been effective in autologous hematopoietic stem cell transplant recipients and patients with solid tumors. 3) Antiviral agents like foscarnet, which have shown potential efficacy in treating acyclovir-resistant varicella-zoster virus infections.

← Back to Search

Vaccine

RNA Vaccine for Shingles

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis, or myocarditis).

Women who are pregnant or breastfeeding.

Must not have

Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis/myocarditis).

Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin I value.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new shingles vaccine called VZV modRNA in healthy people aged 50-69. The vaccine uses mRNA to help the body recognize and fight the virus that causes shingles. The study aims to see how safe the vaccine is and how well it works.

Who is the study for?

Healthy adults aged 50-69 can join this vaccine trial against shingles. They must be able to follow the study plan and not have heart disease, bleeding issues, or a history of severe vaccine reactions. Pregnant women, those on immunosuppressants, or with recent other vaccines are excluded.

What is being tested?

The trial is testing different candidates of a modified RNA shingles vaccine compared to an approved one (Shingrix). It's in two parts: Phase 1 tests safety and immune response with various doses/formulations; Phase 2 uses findings from Phase 1 for further evaluation over up to five years.

What are the potential side effects?

Possible side effects include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses, and potentially others based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a history of heart disease.

Select...

I am not pregnant or breastfeeding.

Select...

I am between 50 and 69 years old.

Select...

I am taking or plan to take drugs that weaken my immune system.

Select...

I have had Guillain-Barré syndrome in the past.

Select...

I have had shingles before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of heart disease.

Select...

My blood tests show some abnormal results.

Select...

I have an infection with HIV, HCV, or HBV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall study: Percentage of participants from both substudies reporting adverse events

Overall study: Percentage of participants from both substudies reporting local reactions

Overall study: Percentage of participants from both substudies reporting medically attended adverse events

+15 more

Secondary study objectives

Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants in both substudies

Overall study: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants from both substudies

Overall study: Proportion of evaluable immunogenicity participants from both substudies with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: Substudy B (SSB): Group 1Experimental Treatment1 Intervention

Selected Vaccine candidate/dose-level/dosing schedule

Group II: SubStudy A (SSA): Group 1Experimental Treatment1 Intervention

Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule

Group III: SSA: Group 7Experimental Treatment1 Intervention

Candidate 3, Frozen, 0, 2 months schedule

Group IV: SSA: Group 5Experimental Treatment1 Intervention

Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule

Group V: SSA: Group 4Experimental Treatment1 Intervention

Candidate 1, Dose Level 2, frozen, 0, 2 months schedule

Group VI: SSA: Group 3Experimental Treatment1 Intervention

Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule

Group VII: SSA: Group 2Experimental Treatment1 Intervention

Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule

Group VIII: SSA: Group 13Experimental Treatment1 Intervention

Candidate 2, Dose level 4, lyophilized, 0, 2 months schedule

Group IX: SSA: Group 12Experimental Treatment1 Intervention

Candidate 2, Dose level 3, lyophilized, 0, 2 months schedule

Group X: SSA: Group 11Experimental Treatment2 Interventions

Candidate 2, Dose level 2, lyophilized, 0, 2 months schedule

Group XI: SSA: Group 10Experimental Treatment1 Intervention

Candidate 1, Dose level 4, lyophilized, 0, 6 months schedule

Group XII: SSA- Group 6Experimental Treatment1 Intervention

Candidate 2, frozen, 0, 2 months schedule

Group XIII: SSA: Group 14Active Control1 Intervention

Shingrix, 0, 2 months schedule

Group XIV: SSA: Group 8Active Control1 Intervention

Shingrix, 0, 2 months schedule

Group XV: SSA: Group 9Active Control1 Intervention

Shingrix, 0, 6 months schedule

Group XVI: SSB: Group 2Active Control1 Intervention

Shingrix

0 / 9Eligibility 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 medications, such as acyclovir, valacyclovir, and famciclovir, which work by inhibiting viral replication, thereby reducing the severity and duration of the infection. Additionally, vaccines like the recombinant zoster vaccine (Shingrix) stimulate the immune system to recognize and fight the virus more effectively. The Varicella Zoster Virus modRNA vaccine under study aims to induce a robust immune response by using modified RNA to produce viral proteins that trigger immunity. This approach is significant for shingles patients as it could offer a more effective and longer-lasting protection against the virus, potentially reducing the incidence and severity of shingles outbreaks.

[Interferon in skin diseases].