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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 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 3,769-participant average among 28 other SARS-CoV-2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 35 participants
Start Date 2022-02-09
Est. Completion 2024-04-19
Phase Phase 1

Sponsor

Sean Liu

1 total trials

What the Registry Record Tells You About NCT05181709

The ClinicalTrials.gov registry entry for NCT05181709 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,769-participant average among 28 other SARS-CoV-2 trials with a reported enrollment target (99% lower). The listed sponsor is Sean Liu, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.