OCU500 ChAd36 Vector COVID-19 Vaccine Phase 1 Trial, 80 Participants
Summary
A Phase 1 randomized, open-label, dose-escalation clinical trial registered for OCU500, a ChAd36 vector vaccine encoding SARS-CoV-2 spike protein, administered via intranasal and inhalational routes. The trial enrolls 80 healthy adults (aged 18-64) previously vaccinated with a primary COVID-19 series and at least one booster. Participants will receive one of two dose levels (1×10^10 VP or 5×10^10 VP) across four study arms of 20 participants each, with the primary objective of evaluating safety and reactogenicity.
What changed
A new Phase 1 clinical trial has been registered on ClinicalTrials.gov for OCU500, a novel ChAd36 adenoviral vector vaccine encoding the SARS-CoV-2 spike protein. The trial will evaluate two dose levels (1×10^10 and 5×10^10 viral particles) delivered via intranasal or inhalational routes in 80 previously vaccinated adults across four study arms.
Sponsors and clinical investigators conducting this trial must ensure compliance with applicable FDA IND regulations, Good Clinical Practice (GCP) standards, and ClinicalTrials.gov registration and results posting requirements. Results must be submitted to ClinicalTrials.gov within 12 months of the primary completion date per FDAAA 801 requirements.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
Phase 1 NCT07536308 Kind: PHASE1 Apr 17, 2026
Abstract
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.
Conditions: COVID-19
Interventions: OCU500
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