NCT06581575

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

A Phase 2, Randomized, Triple-Blinded, Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects ≥ 50 Years of Age

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: Immorna Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix.

Detailed description

This Phase 2 study plans to enroll a total of 460 subjects. This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).

Conditions

• Herpes Zoster (HZ)
• Infectious Diseases
• Shingles

Interventions

Type	Name	Description
BIOLOGICAL	JCXH-105	IM injection
BIOLOGICAL	Shingrix	IM injection

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-09-03
• Last updated: 2025-03-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study