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A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.

NCT05181709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-17

No results posted yet for this 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

Interventions

DRUG

Sodium Chloride

Administered intranasal (IN) and intramuscular (IM) in combination

BIOLOGICAL

NDV-HXP-S IN low dose

Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride. Strength: 3.3x108\^8 EID50.

BIOLOGICAL

NDV-HXP-S IM low dose

Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride. Strength: 3.3x10\^8 EID50.

BIOLOGICAL

NDV-HXP-S IN high dose

Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10\^9 EID50.

BIOLOGICAL

NDV-HXP-S IM high dose

Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10\^9 EID50.

Sponsors & Collaborators

  • Sean Liu

    lead OTHER

Principal Investigators

  • Sean Liu, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2023-05-03
Completion
2024-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181709 on ClinicalTrials.gov