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

Infectious Disease Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05871541
Study type Interventional
Source Immorna Biotherapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 26, 2023
Completion date March 21, 2024
View Details
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