NDV-HXP-S Vaccine for COVID-19
Trial Summary
What is the purpose of this trial?
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.
Research Team
Sean Liu, MD, PhD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults aged 18-59 who've completed an FDA-approved COVID-19 vaccine series at least 6 months ago, not pregnant/breastfeeding, agree to contraception and no other clinical trials for a year. Excludes those with certain diseases (HIV, hepatitis), severe vaccine reactions, or immunocompromising conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NDV-HXP-S vaccine or placebo in an ambulatory setting, followed by home isolation with daily at-home sample collection and online symptom reporting
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of adverse events
Treatment Details
Interventions
- NDV-HXP-S
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sean Liu
Lead Sponsor