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

Phase 1

Active, not recruiting

• Conditions: Infectious Disease; Respiratory Syncytial Virus (RSV)
• Interventions: Other: Placebo; Biological: JCXH-108

• Registration Number: NCT06564194
• Lead Sponsor: Immorna Biotherapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Main

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects randomized to this arm will be given a placebo.
Investigational product	JCXH-108	Subjects randomized to this arm will be given the investigational product (JCXH-108).

Primary Outcome Measures

Name	Time	Method
Medically attended AE frequency	Day 1 - Day 180 (6 Months)	Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
Potential immune-mediated adverse events frequency	Day 1 - Day 180 (6 Months)	Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
SAE Frequency	Day 1 - Day 180 (6 Months)	Frequency of SAEs characterized by type, severity, duration, and relationship to the JCXH-108 recorded from Day 1 (D1) post-vaccine administration through follow-up completion.
Injection site reaction	Day 1 - Day 30	Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)
AE frequency	Day 1 -Day 30	Adverse events (AEs) including unsolicited AEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration to within 30 days following vaccine administration
Solicited systemic reaction frequency	Day 1 - Day 30	Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)

Secondary Outcome Measures

Name	Time	Method
RSV-A and RSV-B antibody levels	Day 1 - Day 180 (6 Months)	Levels of serum neutralizing antibodies against RSV-A and RSV-B as compared to Day 1 pre-dose (baseline) at Day 29, Month 3 and Month 6 after the vaccine administration
IgG antibody levels	Day 1 - Day 30	Levels of serum RSV pre-F antibodies of IgG1, IgG2, IgG3, and IgG4 as compared to Day 1 pre-dose (baseline) at Day 29, after the vaccine administration. Measured in women of childbearing potential only.

Trial Locations

Locations (3)

Health Awareness; 🇺🇸 Jupiter, Florida, United States

DelRicht - New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Sundance Clinical Research; 🇺🇸 Saint Louis, Missouri, United States