A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

A Phase 2, Randomized, Triple-Blinded, Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects ≥ 50 Years of Age

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infectious Diseases; Shingles; Herpes Zoster (HZ)
• Intervention / Treatment: Biological: JCXH-105; Biological: Shingrix

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 receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).

• Study Type: Interventional
• Enrollment (Actual): 467
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • California
    • Long Beach, California, United States, 90805
      • Long Beach Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60652
      • DM Clinical Research - Chicago
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • DM Clinical Research - New Jersey
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Delricht Research
  • Texas
    • Prosper, Texas, United States, 75078
      • Delricht Research
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research - Sugarland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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, 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product; Participants randomized to this arm will be given the investigational product (JCXH-105).	Biological: JCXH-105; IM injection
Active Comparator: Active Control; Participants randomized to this arm will be given the FDA approved Shingrix.	Biological: Shingrix; IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE Frequency	Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion.	Day 1 - Day 241 (Week 34)
Solicited local reaction frequency	Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.	Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Solicited systemic reaction frequency	Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.	Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
AE Frequency	Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.	Day 1 - Day 241 (Week 34)
AESIs Frequency	AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.	Day 1 - Day 241 (Week 34)
Medically Attended AE Frequency	Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.	Day 1 - Day 241 (Week 34)
Immune-Mediated Adverse Events of Special Interest Frequency	Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion.	Day 1 - Day 241 (Week 34)
gE-Specific CD4+ T cell Response Rate	Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose).	Day 1 - Day 89 (Week 13)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular immunogenicity of JCXH-105	Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry with ICS on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose).	Day 1 - Day 241 (Week 34)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular Immunogenicity of JCXH-105	Frequency of gE-specific CD8+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose).	Day 1 - Day 241 (Week 34)
Humoral immunogenicity of JCXH-105	Changes in serum of anti-gE-specific antibody geometric mean titers (GMTs) analyzed with enzyme-linked immunosorbent assay (ELISA) on Day 29, Day 89, and Day 241 as compared to baseline (D1 pre-dose).	Day 1 - Day 241 (Week 34)

Collaborators and Investigators

• Sponsor: Immorna Biotherapeutics, Inc.
• Collaborators: Tigermed Consulting Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Subjects; srRNA; Herpes Zoster (HZ) vaccination
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Pathological Conditions, Signs and Symptoms; Communicable Diseases; Herpes Zoster
• Other Study ID Numbers: JCXH-105-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No