NCT05871541

A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine

A Phase 1 Randomized, Double-Blinded, Active-Controlled, 2-Dose Study to Assess the Safety and Immunogenicity of a Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects 50 to 69 Years of Age.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Immorna Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the safety and immunogenicity of a self-replicating (sr) RNA-based vaccine, JCXH-105, in the prevention of Shingles (Herpes Zoster) Participant will be randomized to receive either JCXH-105 or Shingrix.

Detailed description

This Phase 1 study plans to enroll a total of 75 participants. Three cohorts with 3 different dose levels of JCXH-105 will be explored and each cohort will enroll 25 participants (20 randomized to JCXH-105 and 5 randomized to Shingrix) for a total of 75 participants. The dose level of JCXH-105 will depend on the time the participant joins the study. Each participant will receive two single intramuscular (IM) injections of study treatment (JCXH-105 or Shingrix) on day 1 and day 61 (±2 days on day 61)

Conditions

• Herpes Zoster (HZ)
• Shingles
• Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	JCXH-105	As IM injection
BIOLOGICAL	Active Control (Shingrix)	As IM injection

Timeline

• Start date: 2023-05-26
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2023-05-23
• Last updated: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study