A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine (NCT06581575) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
United States467 participantsStarted 2024-10-16
Plain-language summary
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
Who can participate
Age range
50 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.
Key Inclusion Criteria:
* Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Age: ≥ 50 years of age at screening.
* Status: Healthy subjects.
* Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
* Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
Key Exclusion Criteria:
* Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
* Previous vaccination against HZ.
* 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 the first vaccine administration (JCXH-105 or Shingrix).
* Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
* Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
* Subjects with history of myocarditis or pericarditis…
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 241 (Week 34)
2
Solicited local reaction frequency
Timeframe: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
3
Solicited systemic reaction frequency
Timeframe: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
4
AE Frequency
Timeframe: Day 1 - Day 241 (Week 34)
5
AESIs Frequency
Timeframe: Day 1 - Day 241 (Week 34)
6
Medically Attended AE Frequency
Timeframe: Day 1 - Day 241 (Week 34)
7
Immune-Mediated Adverse Events of Special Interest Frequency