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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05181709
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Geneva Ortiz
Phone (212) 824-7714
Email [email protected]
Status Recruiting
Phase Phase 1
Start date January 2022
Completion date July 2023

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