Actively Recruiting
Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Administered Intranasally and Via Inhalation in Previously Vaccinated Adults
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-05
80
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of OCU500, a new COVID-19 vaccine using a chimpanzee adenovirus vector to deliver the Omicron XBB1.5 spike protein. This phase 1 open-label trial involves healthy adults aged 18 to 64 who have completed their primary COVID-19 vaccination series and received at least one booster. The study aims to assess how well the vaccine is tolerated and its ability to stimulate immune protection in previously vaccinated individuals. The trial tests two dose levels of OCU500 (1x10^10 and 5x10^10 viral particles) delivered either intranasally or by inhalation. Participants are randomly assigned to one of four groups, each receiving a single dose of the vaccine on Day 1. There are 80 participants in total, with 20 in each group. The study is carefully monitoring safety and immune responses over time. Participants will attend study visits for up to six months after vaccination. Researchers will collect blood and nasal samples to measure antibody responses, including IgA and IgG levels against the spike protein. They will also record any adverse events, including local and systemic reactions, serious side effects, and new medical conditions. Safety labs and clinical assessments will be done through Day 8 and follow-up continues through Day 181. The study includes tests to track immune responses to the vaccine vector and overall immune stimulation.
CONDITIONS
Brief 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 understand and agree to study procedures and attend all visits
- Non-pregnant adults aged 18 through 64 at time of vaccination
- Females of childbearing potential must use approved contraception or true abstinence
- Negative urine pregnancy test at screening and within 24 hours before vaccination
- Generally good health with stable chronic conditions for at least 30 days
- Completed primary COVID-19 vaccine series plus at least one booster at least 16 weeks before vaccination
- Clinical labs within normal or grade 1 with no clinical significance
- Agree to have samples stored for secondary research
- Pass a Test of Understanding with at least 90% correct answers
You will not qualify if you...
- Positive SARS-CoV-2 PCR test at screening
- Abnormal vital signs at grade 1 or higher
- COVID-19 infection or vaccination within 16 weeks before vaccination
- Pregnant, breastfeeding, or less than 12 weeks postpartum at vaccination
- Blood or plasma donation within 4 weeks before vaccination or unwilling to refrain until Day 181
- Receipt of antibody or blood products within 90 days before vaccination
- Significant medical or psychiatric diseases affecting safety
- Any respiratory disease including COPD or asthma
- Neurological or neurodevelopmental conditions such as epilepsy or multiple sclerosis
- Cardiovascular disease including myocarditis or uncontrolled arrhythmia
- Autoimmune diseases
- Significant nasal or upper airway diseases or use of intranasal medications
- Acute illness within 72 hours before vaccination
- Positive hepatitis B, hepatitis C, or HIV test at screening
- Immunosuppressive or immunodeficient states
- Recent investigational product use
- History of severe allergic reaction to vaccines
- Chronic idiopathic urticaria
- Recent live or inactivated vaccine use
- Plans to receive COVID-19 vaccine within 180 days after vaccination
- History of smoking or intranasal drug use
- Planned international travel between vaccination and Day 29
- Previous receipt of adenovirus-vector vaccine by intranasal or aerosol routes
- Bleeding disorders or history of significant bleeding
- Recent major surgery, immobility, chronic infection, or head trauma
- History of thrombosis or thrombophilic conditions
- Body mass index 40 kg/m2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (Day 1)
Participants receive a single dose of the OCU500 vaccine via intranasal or inhalation route, with dose levels of 1×10^10 or 5×10^10 viral particles.
1 vaccination visit (in-person)
Duration - Up to 6 months post vaccination
Participants are monitored for safety, adverse events, and immune responses after vaccination.
Multiple follow-up visits up to Day 181
Trial Site Locations
Total: 6 locations
1
The Hope Clinic of Emory University
Decatur, Georgia, United States, 30030-1705
Actively 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
Saint Louis University Center for Vaccine Development
St Louis, Missouri, United States, 63104-1015
Not Yet Recruiting
5
Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
St Louis, Missouri, United States, 63110
Withdrawn
6
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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