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

NCT ID: NCT06581575

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2025-08-31

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 either JCXH-105 or 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).

Conditions

Herpes Zoster (HZ); Infectious Diseases; Shingles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Product

Participants randomized to this arm will be given the investigational product (JCXH-105).

Group Type: EXPERIMENTAL

JCXH-105

Intervention Type: BIOLOGICAL

IM injection

Active Control

Participants randomized to this arm will be given the FDA approved Shingrix.

Group Type: ACTIVE_COMPARATOR

Shingrix

Intervention Type: BIOLOGICAL

IM injection

Interventions

JCXH-105

IM injection

Intervention Type: BIOLOGICAL

Shingrix

IM injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Immorna Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Noble Clinical Research

Tucson, Arizona, United States

Long Beach Research Institute

Long Beach, California, United States

DM Clinical Research - Chicago

Chicago, Illinois, United States

Quality Clinical Research

Omaha, Nebraska, United States

DM Clinical Research - New Jersey

Jersey City, New Jersey, United States

Delricht Research

Charleston, South Carolina, United States

Delricht Research

Prosper, Texas, United States

DM Clinical Research - Sugarland

Sugar Land, Texas, United States

Countries

United States

Other Identifiers

JCXH-105-021

Identifier Type: -

Identifier Source: org_study_id