Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Lead Sponsor:
Immorna Biotherapeutics, Inc.
Collaborating Sponsors:
Tigermed Consulting Co., Ltd
Conditions:
Respiratory Syncytial Virus (RSV)
Infectious Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 disease...
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 w...
Eligibility Criteria
Inclusion
- Main
- 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
- 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).
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06564194
Start Date
September 25 2024
End Date
June 1 2025
Last Update
April 30 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Health Awareness
Jupiter, Florida, United States, 33458
2
DelRicht - New Orleans
New Orleans, Louisiana, United States, 70115
3
Sundance Clinical Research
St Louis, Missouri, United States, 63131