A Phase 2 interventional study of JCXH-105 and Shingrix in Herpes Zoster (HZ), Infectious Diseases and Shingles, sponsored by Immorna Biotherapeutics, Inc.. Active, not recruiting at 8 sites in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Immorna Biotherapeutics, Inc. · Phase 2, Interventional, and Prevention
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.
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 467 is above the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Immorna Biotherapeutics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants randomized to this arm will be given the investigational product (JCXH-105).
Biological: JCXH-105
Participants randomized to this arm will be given the FDA approved Shingrix.
Biological: Shingrix
IM injection
IM injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Day 1 - Day 89 (Week 13)
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).
Time frame: Day 1 - Day 241 (Week 34)
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).
Time frame: 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).
Time frame: Day 1 - Day 241 (Week 34)
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Immorna Biotherapeutics, Inc.