A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV (NCT06564194) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
United States75 participantsStarted 2024-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Main 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 investigationa…
What they're measuring
1
SAE Frequency
Timeframe: Day 1 - Day 180 (6 Months)
2
Injection site reaction
Timeframe: Day 1 - Day 30
3
Solicited systemic reaction frequency
Timeframe: Day 1 - Day 30
4
AE frequency
Timeframe: Day 1 -Day 30
5
Medically attended AE frequency
Timeframe: Day 1 - Day 180 (6 Months)
6
Potential immune-mediated adverse events frequency