Clinical trial NCT06581575: A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Herpes Zoster (HZ)
Infectious Diseases
Shingles
Keywords: srRNA
Herpes Zoster (HZ) vaccination
Healthy Subjects
Lead sponsor: Immorna Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2024-09-03
Enrollment: 467
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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 \&gt;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).

Primary outcomes:
measure: SAE Frequency
timeFrame: Day 1 - Day 241 (Week 34)
measure: Solicited local reaction frequency
timeFrame: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
measure: Solicited systemic reaction frequency
timeFrame: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
measure: AE Frequency
timeFrame: Day 1 - Day 241 (Week 34)
measure: AESIs Frequency
timeFrame: Day 1 - Day 241 (Week 34)
measure: Medically Attended AE Frequency
timeFrame: Day 1 - Day 241 (Week 34)
measure: Immune-Mediated Adverse Events of Special Interest Frequency
timeFrame: Day 1 - Day 241 (Week 34)
measure: gE-Specific CD4+ T cell Response Rate
timeFrame: Day 1 - Day 89 (Week 13)
Secondary outcomes:
measure: Cellular immunogenicity of JCXH-105
timeFrame: Day 1 - Day 241 (Week 34)
Other outcomes:
measure: Cellular Immunogenicity of JCXH-105
timeFrame: Day 1 - Day 241 (Week 34)
measure: Humoral immunogenicity of JCXH-105
timeFrame: Day 1 - Day 241 (Week 34)
Locations:
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Chicago
country: United States
facility: DM Clinical Research - Chicago
state: Illinois
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Jersey City
country: United States
facility: DM Clinical Research - New Jersey
state: New Jersey
city: Charleston
country: United States
facility: Delricht Research
state: South Carolina
city: Prosper
country: United States
facility: Delricht Research
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland
state: Texas
Study officials:
References: