What side effects are associated with this type of intervention?

The most common treatments for Shingles include vaccines like Shingrix and antiviral medications such as acyclovir. Shingrix, a recombinant zoster vaccine, is known to cause local adverse events such as regional pain, erythema, and swelling, as well as systemic reactions including fever, fatigue, and headache. Antiviral medications like acyclovir are generally well-tolerated but can cause mild side effects such as nausea, diarrhea, and headache. These treatments aim to reduce the severity and duration of Shingles symptoms and prevent complications like postherpetic neuralgia.

What prior FDA approvals exist?

The FDA has approved several treatments for Shingles, primarily focusing on antiviral medications and vaccines. Antiviral drugs such as acyclovir, valacyclovir, and famciclovir are commonly used to reduce the severity and duration of Shingles symptoms. In terms of vaccines, the FDA has approved Zostavax, a live attenuated vaccine, and Shingrix, a recombinant subunit vaccine, to prevent Shingles. While there are no prior FDA approvals for self-replicating RNA-based vaccines specifically for Shingles, the ongoing study of JCXH-105 represents a novel approach in this area.

What other types of research exist?

A promising, novel alternative to the JCXH-105 vaccine for Shingles patients is Shingrix, an established recombinant zoster vaccine. It has been widely used and proven effective in preventing Shingles. As of now, there are no other specific novel vaccines mentioned in the provided context that are expected to be available in 2024. Patients should consult with their healthcare provider to discuss the best available options.

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Virus Therapy

JCXH-105 Vaccine for Shingles (JCXH-105 Trial)

Phase 1

Waitlist Available

Research Sponsored by Immorna Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Age: 50 to 69 years of age, inclusive, at screening.

Be older than 18 years old

Must not have

Subjects receiving systemic antiviral therapy.

Subjects who have received an mRNA-based vaccine (e.g., Spikevax, Comirnaty, etc.) 30 days prior to Day 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 - day 241

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine called JCXH-105, which uses self-replicating RNA to help the body fight Shingles. It targets people who are at risk of Shingles and aims to see if this new approach is safe and effective.

Who is the study for?

This trial is for healthy men and women aged 50 to 69 who have stable health without significant active or chronic diseases. They must not be on systemic antiviral therapy, have no recent vaccines, and agree not to take any herpes zoster vaccine during the study. Individuals with a history of shingles, immunosuppression, or certain heart conditions after mRNA vaccination are excluded.

What is being tested?

The trial tests JCXH-105, an srRNA-based vaccine against Shingles (Herpes Zoster), compared to Shingrix as an active control. Participants will randomly receive one of these two vaccines to evaluate safety and immune response effectiveness.

What are the potential side effects?

While specific side effects for JCXH-105 aren't listed here, typical vaccine-related side effects may include pain at the injection site, fatigue, headache, muscle pain, chills, fever and nausea. Serious side effects could involve allergic reactions or more severe responses.

Eligibility Criteria

Inclusion Criteria

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

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I am between 50 and 69 years old.

Exclusion Criteria

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

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I am currently on antiviral medication.

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I received an mRNA COVID-19 vaccine at least 30 days ago.

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I have had severe reactions to mRNA vaccines or have had myocarditis or pericarditis.

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I have an immune system condition.

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I have had shingles or currently have it.

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I have been vaccinated against shingles.

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I have a history of tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - day 241

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 - day 241

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - day 241 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AE frequency

Injection site reaction

Medically attended AE frequency

+3 more

Secondary study objectives

Cellular immunogenicity of the JCXH-105 and Shingrix vaccine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational ProductExperimental Treatment1 Intervention

Participants randomized to this arm will be given the investigational product (JCXH-105).

Group II: Active ControlActive Control1 Intervention

Participants randomized to this arm will be given the FDA approved Shingrix.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JCXH-105

2023

Completed Phase 1

~80

0 / 8Eligibility 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 like acyclovir, valacyclovir, and famciclovir, which work by inhibiting viral replication, thereby reducing the severity and duration of the infection. Vaccines such as Shingrix and the self-replicating RNA-based vaccine JCXH-105 aim to prevent Shingles by stimulating the immune system to recognize and fight the varicella-zoster virus. These treatments are crucial for Shingles patients as they help manage symptoms, reduce complications like postherpetic neuralgia, and prevent the reactivation of the virus in immunocompromised individuals.

Varicella zoster virus infection associated with high-dose chemotherapy and autologous stem-cell rescue.