NCT07536308

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Secondary objectives include evaluating systemic anti-Spike humoral responses, nasal mucosal Immunoglobulin A (IgA) and Immunoglobulin G (IgG) responses, and immune responses toward vectors.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	OCU500	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.

Timeline

• Start date: 2026-04-29
• Primary completion: 2027-04-29
• Completion: 2027-11-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study