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

Completed · Phase 1

Conditions studied: Herpes Zoster (HZ), Shingles, Infectious Disease

In brief

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.

Key facts

Study ID

NCT05871541

Run by

Immorna Biotherapeutics, Inc.

People needed

75

Starts

2023-05-26

Expected to finish

2024-03-25

Last updated by the study team

2024-09-19

Who can join

Age: 50 and older, up to 69. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• CenExel RCA — Hollywood, Florida, United States
• CenExel FCR — Tampa, Florida, United States
• CenExel HRI — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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