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

NCT ID: NCT06564194

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational product

Subjects randomized to this arm will be given the investigational product (JCXH-108).

Group Type: EXPERIMENTAL

JCXH-108

Intervention Type: BIOLOGICAL

IM injection

Placebo

Subjects randomized to this arm will be given a placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

IM injection

Interventions

JCXH-108

IM injection

Intervention Type: BIOLOGICAL

Placebo

IM injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sex: Male or female; female subjects may be of childbearing potential or postmenopausal.
• Age: 18-45 years of age or ≥ 60 years of age at screening
• Status: Healthy subjects.
• Subjects must agree to not be vaccinated with any RSV vaccine while participating in this study.
• Subjects must agree to not be vaccinated with any RNA-based vaccines 30 days before D1 through 30 days after D1.

Exclusion Criteria

• Subjects with current diagnosis of RSV infection or diseases.
• Previous vaccination against RSV.
• Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization >24 hours for any reason within the past month prior to Day 1.
• Subjects with history of myocarditis or pericarditis, or with adverse events (AEs) after mRNA vaccination that are in nature and severity beyond the common expected AEs necessitating medical intervention.
• Subjects who received any non-live vaccine within 14 days prior to Day 1.
• Subjects who received within 28 days prior to Day 1: (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, and (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable dose of steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed.
• Subjects who currently receive other investigational agents or devices.
• Subjects with active or suspected immunosuppression, immunodeficiency, asplenia, recurrent severe infections or autoimmune diseases. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
• Subjects receiving systemic antiviral therapy.
• Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human HIV-1 and 2 antibodies, syphilis.
• Subjects with a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or on Day 1 prior to vaccine administration (JCXH-108 or placebo).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Immorna Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Health Awareness

Jupiter, Florida, United States

DelRicht - New Orleans

New Orleans, Louisiana, United States

Sundance Clinical Research

St Louis, Missouri, United States

Countries

United States

Other Identifiers

JCXH-108-001

Identifier Type: -

Identifier Source: org_study_id