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NCT05181709 · ClinicalTrials.gov registry record · Phase 1
A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.
A Phase 1 study of SARS-CoV-2, sponsored by Sean Liu.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05181709: Completed Phase 1 study of SARS-CoV-2, sponsored by Sean Liu.
NCT05181709 is a Phase 1 study of SARS-CoV-2 that has completed, run by Sean Liu. The registered enrollment target is 35 participants, below the 3,453-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05181709, a Phase 1 study of SARS-CoV-2, has completed, sponsored by Sean Liu.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized against COVID-19. The IN and IM live virus vaccinations will be identical in composition and only differ in route of administration.
Primary Outcome
The safety and tolerability profile assessed by the number of local and systemic reactions.
Conditions Studied
Interventions
- DRUG Sodium Chloride
- BIOLOGICAL NDV-HXP-S IN low dose
- BIOLOGICAL NDV-HXP-S IM low dose
- BIOLOGICAL NDV-HXP-S IN high dose
- BIOLOGICAL NDV-HXP-S IM high dose
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-02-09 |
| Est. Completion | 2024-04-19 |
| Phase | Phase 1 |
What the finished NCT05181709 record still lists
NCT05181709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 3,453-participant average among 34 other SARS-CoV-2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with SARS-CoV-2 appearing as the primary indexed condition, and to 5 interventions - of which Sodium Chloride is the first listed.
NCT05181709 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05181709 about?
NCT05181709 is a clinical study titled "A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.". This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized...
What is the current status of trial NCT05181709?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-02-09. Estimated completion is 2024-04-19.
What conditions does trial NCT05181709 study?
This clinical trial studies the following conditions: SARS-CoV-2.
What interventions are being tested in trial NCT05181709?
The interventions under investigation include: Sodium Chloride (DRUG), NDV-HXP-S IN low dose (BIOLOGICAL), NDV-HXP-S IM low dose (BIOLOGICAL), NDV-HXP-S IN high dose (BIOLOGICAL), NDV-HXP-S IM high dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT05181709?
This trial is sponsored by Sean Liu, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05181709 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05181709's enrollment target sits among peer trials
35 33rd of 34 higher than 2 of 34 other SARS-CoV-2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS-CoV-2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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