A First-in-Human Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
- Conditions
- Herpes Zoster (HZ)ShinglesInfectious Disease
- Interventions
- Biological: Active Control (Shingrix)
- Registration Number
- NCT05871541
- Lead Sponsor
- Immorna Biotherapeutics, Inc.
- 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.
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Control Active Control (Shingrix) Participants randomized to this arm will be given the FDA approved Shingrix. Investigational Product JCXH-105 Participants randomized to this arm will be given the investigational product (JCXH-105).
- Primary Outcome Measures
Name Time Method Solicited systemic reaction frequency 7 days after the first and second vaccination Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
Injection site reaction 7 days after the first and second vaccination Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
AE frequency 30 days after the first and second vaccination 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
SAE Frequency Day 1 - Day 241 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
Medically attended AE frequency Day 1 - Day 241 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
The frequency of potential immune-mediated adverse events" Day 1 - Day 241 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
- Secondary Outcome Measures
Name Time Method Cellular immunogenicity of the JCXH-105 and Shingrix vaccine Day 1 - Day 241 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)
Trial Locations
- Locations (3)
CenExel RCA
🇺🇸Hollywood, Florida, United States
CenExel FCR
🇺🇸Tampa, Florida, United States
CenExel HRI
🇺🇸Berlin, New Jersey, United States