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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
467
Noble Clinical Research
Tucson, Arizona, United States
Long Beach Research Institute
Long Beach, California, United States
DM Clinical Research - Chicago
Chicago, Illinois, United States
Quality Clinical Research
Omaha, Nebraska, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DM Clinical Research - New Jersey
Jersey City, New Jersey, United States
Delricht Research
Charleston, South Carolina, United States
Delricht Research
Prosper, Texas, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, United States
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)