NCT06564194

A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV

A Phase 1 Randomized, Double-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of JCXH-108, an mRNA-based Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Healthy Subjects ≥ 60 Years of Age and 18-45 Years of Age

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Immorna Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases. Participants will be randomized to receive either JCXH-108 or placebo.

Detailed description

This Phase 1 study plans to enroll a total of 75 participants. Three cohorts with two different dose levels will be explored and each cohort will enroll 25 participants. Participants in each cohort will be randomized (4:1) to receive either JCXH-108 (n=20) or placebo (normal saline, n=5). A low dose of JCXH-108 will be explored vs placebo in the 18-45 years of age group first. A high dose will be explored vs placebo in the 18-45 years and ≥ 60 years of age groups once safety data is reviewed for the Sentinel subjects in the low dose cohort. The dose level of JCXH-108 will depend on the time the participant joins the study. Each participant will receive a single dose of JCXH-108 administered intramuscularly (IM) on day 1.

Conditions

• Respiratory Syncytial Virus (RSV)
• Infectious Disease

Interventions

Type	Name	Description
BIOLOGICAL	JCXH-108	IM injection
OTHER	Placebo	IM injection

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-08-21
• Last updated: 2025-04-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study