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

NCT06564194 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: JCXH-108-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Syncytial Virus (RSV); Infectious Disease

Keywords

mRNA vaccine; RSV vaccination; Healthy subjects

Outcome Measures

Primary Outcomes (6)

• SAE Frequency

  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.

  Day 1 - Day 180 (6 Months)

• Injection site reaction

  Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)

  Day 1 - Day 30

• Solicited systemic reaction frequency

  Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)

  Day 1 - Day 30

• AE frequency

  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

  Day 1 -Day 30

• Medically attended AE frequency

  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

  Day 1 - Day 180 (6 Months)

• Potential immune-mediated adverse events frequency

  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

  Day 1 - Day 180 (6 Months)

Secondary Outcomes (2)

• RSV-A and RSV-B antibody levels

  Day 1 - Day 180 (6 Months)

• IgG antibody levels

  Day 1 - Day 30

Other Outcomes (1)

• T-cell responses

  Day 1 -Day 180 (6 Months)

Study Arms (2)

Investigational product

EXPERIMENTAL

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

Biological: JCXH-108

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will be given a placebo.

Other: Placebo

Interventions

JCXH-108 BIOLOGICAL

IM injection

Investigational product

Placebo OTHER

IM injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (3)

Health Awareness

Jupiter, Florida, 33458, United States

Location

DelRicht - New Orleans

New Orleans, Louisiana, 70115, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (3)