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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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