RecruitingPhase 1NCT07536308

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

80 participants

Start Date

May 4, 2026

Study Type

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called OCU500 for people with covid-19. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 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. to {"Phase 1"}.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOCU500

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)

The Hope Clinic of Emory University

Decatur, Georgia, United States

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Saint Louis University Center for Vaccine Development

St Louis, Missouri, United States

Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit

St Louis, Missouri, United States

University of Texas Medical Branch

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07536308


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