Status:
ACTIVE_NOT_RECRUITING
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Lead Sponsor:
Immorna Biotherapeutics, Inc.
Collaborating Sponsors:
Tigermed Consulting Co., Ltd
Conditions:
Herpes Zoster (HZ)
Infectious Diseases
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 e...
Detailed Description
This Phase 2 study plans to enroll a total of 460 subjects. This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to...
Eligibility Criteria
Inclusion
- Key
- 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
- 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, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
- Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
- Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
- Subjects receiving systemic antiviral therapy.
- Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
- Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Key Trial Info
Start Date :
October 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT06581575
Start Date
October 16 2024
End Date
August 1 2025
Last Update
March 19 2025
Active Locations (8)
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1
Noble Clinical Research
Tucson, Arizona, United States, 85704
2
Long Beach Research Institute
Long Beach, California, United States, 90805
3
DM Clinical Research - Chicago
Chicago, Illinois, United States, 60652
4
Quality Clinical Research
Omaha, Nebraska, United States, 68114