A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine

NCT05871541 | Completed Phase 1 FDA Drug

• 1 other identifier: JCXH-105-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Herpes Zoster (HZ); Shingles; Infectious Disease

Keywords

srRNA vaccine; Shingles vaccine; Herpes Zoster (HZ) vaccine; Healthy adult participants (aged 50 to 69 years)

Outcome Measures

Primary Outcomes (6)

• SAE Frequency

  Frequency of SAEs characterized by type, 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

• Injection site reaction

  Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)

  7 days after the first and second vaccination

• Solicited systemic reaction frequency

  Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)

  7 days after the first and second vaccination

• AE frequency

  Adverse events (AEs) including unsolicited AEs, characterized by type, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration to within 30 days following each vaccine administration

  30 days after the first and second vaccination

• Medically attended AE frequency

  Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion

  Day 1 - Day 241

• The frequency of potential immune-mediated adverse events"

  Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion

  Day 1 - Day 241

Secondary Outcomes (1)

• Cellular immunogenicity of the JCXH-105 and Shingrix vaccine

  Day 1 - Day 241

Study Arms (2)

Investigational Product

EXPERIMENTAL

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

Biological: JCXH-105

Active Control

ACTIVE COMPARATOR

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

Biological: Active Control (Shingrix)

Interventions

JCXH-105 BIOLOGICAL

As IM injection

Investigational Product

Active Control (Shingrix) BIOLOGICAL

As IM injection

Active Control

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-105 or Shingrix).
• Subjects with history of myocarditis or pericarditis, or with AEs after mRNA vaccination that are in nature and severity beyond the common expected AEs necessitating medical intervention.
• Subjects who have received an mRNA-based vaccine (e.g., Spikevax, Comirnaty, etc.) 30 days prior to Day 1.
• Subjects who received any non-live vaccine within 14 days prior to the first vaccine administration (JCXH-105 or Shingrix).
• Subjects who received within 28 days prior to first vaccine administration (JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) 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 with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.
• Subjects receiving systemic antiviral therapy.
• Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human HIV-1 and 2 antibodies.
• Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• Subjects with a known history of active or latent tuberculosis (bacillus tuberculosis).

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead
• ICON plc: collaborator

Study Sites (3)

CenExel RCA

Hollywood, Florida, 33024, United States

Location

CenExel FCR

Tampa, Florida, 33613, United States

Location

CenExel HRI

Berlin, New Jersey, 08009, United States

Location

MeSH Terms

Conditions

Herpes Zoster; Communicable Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 23, 2023
• Study Start: May 26, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)