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NCT05871541 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine
A Phase 1 study of Infectious Disease and Shingles, sponsored by Immorna Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 3
- Study locations
NCT05871541: Completed Phase 1 study of Infectious Disease and Shingles, sponsored by Immorna Biotherapeutics.
NCT05871541 is a Phase 1 study of Infectious Disease and Shingles that has completed, run by Immorna Biotherapeutics. The registered enrollment target is 75 participants, below the 7,021-participant average among 18 other Infectious Disease trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05871541, a Phase 1 study of Infectious Disease and Shingles, has completed, sponsored by Immorna Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL JCXH-105
- BIOLOGICAL Active Control (Shingrix)
Study Locations (3)
Florida
- CenExel RCA - Hollywood
- CenExel FCR - Tampa
New Jersey
- CenExel HRI - Berlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-05-26 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 1 |
What the finished NCT05871541 record still lists
NCT05871541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 7,021-participant average among 18 other Infectious Disease trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Infectious Disease appearing as the primary indexed condition, and to 2 interventions - of which JCXH-105 is the first listed.
NCT05871541 reports a single indexed study location in Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05871541 about?
NCT05871541 is a clinical study titled "A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine". 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.
What is the current status of trial NCT05871541?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2023-05-26. Estimated completion is 2024-03-25.
What conditions does trial NCT05871541 study?
This clinical trial studies the following conditions: Infectious Disease, Shingles, Herpes Zoster (HZ).
What interventions are being tested in trial NCT05871541?
The interventions under investigation include: JCXH-105 (BIOLOGICAL), Active Control (Shingrix) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05871541?
This trial is sponsored by Immorna Biotherapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05871541 being conducted?
This trial has 3 study locations across Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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