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

Infectious Disease Clinical Trial

— JCXH-105  

Official title:

A Phase 1 Randomized, Double-Blinded, Active-Controlled, 2-Dose Study to Assess the Safety and Immunogenicity of a Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects 50 to 69 Years of Age.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05871541
• Other study ID #: JCXH-105-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 26, 2023
• Est. completion date: March 21, 2024

Study information

• Verified date: November 2023
• Source: Immorna Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This Phase 1 study plans to enroll a total of 75 participants. Three cohorts with 3 different dose levels of JCXH-105 will be explored and each cohort will enroll 25 participants (20 randomized to JCXH-105 and 5 randomized to Shingrix) for a total of 75 participants. The dose level of JCXH-105 will depend on the time the participant joins the study. Each participant will receive two single intramuscular (IM) injections of study treatment (JCXH-105 or Shingrix) on day 1 and day 61 (±2 days on day 61)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: March 21, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Communicable Diseases
• Herpes Simplex
• Herpes Zoster
• Infections
• Infectious Disease
• Shingles

Intervention

Biological:
• JCXH-105
As IM injection
• Active Control (Shingrix)
As IM injection

Locations

Country	Name	City	State
United States	CenExel HRI	Berlin	New Jersey
United States	CenExel RCA	Hollywood	Florida
United States	CenExel FCR	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Immorna Biotherapeutics, Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cellular immunogenicity of the JCXH-105 and Shingrix vaccine	Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation in peripheral blood mononuclear cells (PBMCs) analyzed with flow cytometry on Day 1 pre-dose (baseline) and Days 15, 31, 75, 91, and 241 (Follow-up visit)	Day 1 - Day 241