A Phase 2 Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine
NCT Number: NCT06581575
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Herpes Zoster (HZ)|Infectious Diseases|Shingles
Sponsor: Immorna Biotherapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 460
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-08

Summary:
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).

Subjects will be randomized to receive either JCXH-105 or Shingrix.

Primary Outcome Measures: SAE Frequency, Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion., Day 1 - Day 241 (Week 34)|Solicited local reaction frequency, Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration., Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)|Solicited systemic reaction frequency, Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration., Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)|AE Frequency, Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion., Day 1 - Day 241 (Week 34)|AESIs Frequency, AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion., Day 1 - Day 241 (Week 34)|Medically Attended AE Frequency, Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion., Day 1 - Day 241 (Week 34)|Immune-Mediated Adverse Events of Special Interest Frequency, Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, 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 (Week 34)|gE-Specific CD4+ T cell Response Rate, Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose)., Day 1 - Day 89 (Week 13)
Secondary Outcome Measures: Cellular immunogenicity of JCXH-105, Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry with ICS on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose)., Day 1 - Day 241 (Week 34)
Other Outcome Measures: Cellular Immunogenicity of JCXH-105, Frequency of gE-specific CD8+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose)., Day 1 - Day 241 (Week 34)|Humoral immunogenicity of JCXH-105, Changes in serum of anti-gE-specific antibody geometric mean titers (GMTs) analyzed with enzyme-linked immunosorbent assay (ELISA) on Day 29, Day 89, and Day 241 as compared to baseline (D1 pre-dose)., Day 1 - Day 241 (Week 34)