A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
NCT Number: NCT06564194
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Respiratory Syncytial Virus (RSV)|Infectious Disease
Interventions: BIOLOGICAL: JCXH-108|OTHER: Placebo
Sponsor: Immorna Biotherapeutics, Inc.
Collaborators: Tigermed Consulting Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-03
Locations: Sundance Clinical Research, Jupiter, Florida, 33458, United States|DelRicht - New Orleans, New Orleans, Louisiana, 70115, United States|Health Awareness, Saint Louis, Missouri, 63131, United States

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.

Primary Outcome Measures: 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 Outcome Measures: RSV-A and RSV-B antibody levels, 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, Day 1 - Day 180 (6 Months)|IgG antibody levels, 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., Day 1 - Day 30
Other Outcome Measures: T-cell responses, T-cell responses to vaccine-encoded antigen in peripheral blood mononuclear cells (PBMCs) determined by enzyme-linked immunosorbent spot (ELISpot) and Intracellular Cytokine Staining (ICS) assays, as compared to baseline (Day 1 pre-dose) at 29 days and 6 months after the vaccine administration (Day 30 and Month 6)., Day 1 -Day 180 (6 Months)