A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
A Phase 1 Open-Label Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike, A Next-Generation SARS-CoV-2 Booster Vaccine Via Intranasal and Inhalational Routes, in Previously Vaccinated Adults
National Institute of Allergy and Infectious Diseases (NIAID)
80 participants
May 4, 2026
INTERVENTIONAL
Conditions
Summary
This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a primary COVID-19 vaccination series and at least one booster. The study evaluates two dose levels (1×10\^10 viral particles (VP) and 5×10\^10 VP) and two routes of administration (intranasal and inhaled). The trial includes 80 participants across four study arms (20 per arm). The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy adults.
Eligibility
Plain Language Summary
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Interventions
OCU500 is a monovalent, replication-defective, chimpanzee adenovirus (ChAd36)-vectored COVID-19 vaccine that encodes a codon-optimized, stabilized prefusion form of the spike (S) protein from the Omicron XBB1.5 strain.
Locations(6)
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NCT07536308