NCT05181709

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

A Phase-1, Open-Label, Placebo-Controlled Evaluation of a Live, Recombinant Newcastle Disease Virus Expressing the Spike Protein of SARS-CoV-2 (NDV-HXP-S), an Investigational Product for Intranasal (IN) and/or Intramuscular (IM) Vaccination in Healthy Adults Previously Immunized Against COVID-19.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sean Liu · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 14 days after administration. Secondary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 365 days after administration.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-05-03
• Completion: 2024-04-19
• First posted: 2022-01-06
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study