Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581575
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
A Phase 2 Study to Evaluate JCXH-105 an SrRNA-based Herpes Zoster Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Triple-Blinded Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster HZ Vaccine JCXH-105 in Healthy Subjects 50 Years of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Subjects will be randomized to receive either JCXH-105 or Shingrix
Detailed Description:
This Phase 2 study plans to enroll a total of 460 subjects
This will be an active-controlled study in healthy male andor female subjects 50 years of age or older Subjects will be randomized 11 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 n230 or Shingrix n230
This will be an active-controlled study in healthy male andor female subjects 50 years of age or older Subjects will be randomized 11 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 n230 or Shingrix n230
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None