A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine (NCT05871541) | Clinical Trial Compass
CompletedPhase 1
A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine
United States75 participantsStarted 2023-05-26
Plain-language summary
The goal of this clinical trial is to assess the safety and immunogenicity of a self-replicating (sr) RNA-based vaccine, JCXH-105, in the prevention of Shingles (Herpes Zoster)
Participant will be randomized to receive either JCXH-105 or Shingrix.
Who can participate
Age range50 Years – 69 Years
SexALL
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Inclusion Criteria:
* Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Age: 50 to 69 years of age, inclusive, at screening.
* Status: Healthy subjects. Note: Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease, in the opinion of the Investigator, following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG) recording, hematology, blood chemistry, serology, and urinalysis. Healthy subjects may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment.
* Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
* All values for hematology and clinical chemistry tests of blood and urine within the normal range OR showing no clinically relevant deviations based on medical history, considering stable pre-existing diseases (see Healthy Subjects above), as judged by the Investigator.
Exclusion Criteria:
* Subjects with a history of HZ or current diagnosis of shingles.
* 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-10…
What they're measuring
1
SAE Frequency
Timeframe: Day 1 - Day 241
2
Injection site reaction
Timeframe: 7 days after the first and second vaccination
3
Solicited systemic reaction frequency
Timeframe: 7 days after the first and second vaccination
4
AE frequency
Timeframe: 30 days after the first and second vaccination
5
Medically attended AE frequency
Timeframe: Day 1 - Day 241
6
The frequency of potential immune-mediated adverse events"