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A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT05871541•Immorna Biotherapeutics, Inc.

View on ClinicalTrials.gov

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.

Detailed 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)

Eligibility

Age

50 - 69 years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (3)

CenExel RCA

Hollywood, Florida, United States

CenExel FCR

Tampa, Florida, United States

CenExel HRI

Berlin, New Jersey, United States

Key Dates

Start Date

May 26, 2023

Primary Completion Date

March 25, 2024

Completion Date

March 25, 2024

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Herpes Zoster (HZ)ShinglesInfectious Disease

Interventions

JCXH-105

BIOLOGICAL

Active Control (Shingrix)

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

An International Observational Study of Adults With Acute Infection

Prescription Support System for Antimicrobial Use in Belgian Primary Care

L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)

Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

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