Actively Recruiting
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-08
80
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides written informed consent before any study procedures.
- Able to comply with study procedures and attend all visits.
- Adults aged 18 through 64 years at the time of vaccine administration.
- Non-pregnant; participants of childbearing potential must use acceptable contraception or practice true abstinence.
- Negative pregnancy test at screening and within 24 hours before vaccine administration (if applicable).
- Generally in good health with stable chronic medical conditions.
- Completed a full primary COVID-19 vaccine series and received at least one booster at least 16 weeks prior.
- Clinical lab values within normal or grade 1 without clinical significance.
- Agree to have samples stored for secondary research.
- Pass a Test of Understanding by answering at least 90% of questions correctly.
You will not qualify if you...
- Positive SARS-CoV-2 PCR test at screening.
- Abnormal vital signs (grade 1 or higher).
- COVID-19 infection or any COVID-19 vaccine received within 16 weeks prior to vaccine administration.
- Pregnant, breastfeeding, or less than 12 weeks postpartum.
- Blood or plasma donation within 4 weeks prior or unwilling to refrain until Day 181.
- Received antibody or blood-derived products within 90 days prior.
- Significant medical or psychiatric diseases that preclude participation.
- Any respiratory diseases including COPD, asthma, interstitial lung disease.
- Neurological or neurodevelopmental disorders.
- Cardiovascular diseases including myocarditis, pericarditis, or uncontrolled arrhythmia.
- Autoimmune diseases including hypothyroidism without known non-autoimmune cause.
- Significant nasal or upper airway diseases or recent intranasal medication use.
- Acute illness within 72 hours before vaccination.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Immunosuppressive or immunodeficient states.
- Participation in other investigational product trials within 60 days.
- History of severe allergic reaction to vaccines or vaccine components.
- History of chronic idiopathic urticaria.
- Recent receipt or planned receipt of other vaccines within specified timeframes.
- Plan to receive a COVID-19 vaccine within 180 days after study vaccine.
- Smoking or intranasal illicit drug use within specified time periods.
- Planned international travel between vaccination and Day 29.
- Previous receipt of adenovirus-vector vaccine via intranasal or aerosol routes.
- Bleeding disorders or history of significant bleeding with injections.
- Recent major surgery, immobility, chronic infection, or head trauma increasing thrombosis risk.
- History of thrombosis or known thrombophilic conditions.
- Body mass index equal to or greater than 40 kg/m2.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
The Hope Clinic of Emory University
Decatur, Georgia, United States, 30030-1705
Not Yet Recruiting
2
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201-1509
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115-6110
Not Yet Recruiting
4
Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
St Louis, Missouri, United States, 63110
Withdrawn
5
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0435
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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