OCU500 Vaccine for Coronavirus

Recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Intranasal medications

Disqualifiers: SARS-CoV-2 infection, Respiratory disease, Neurological conditions, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

1. Provides written informed consent before initiation of any study procedures.

I am between 18 and 64 years old and not pregnant.

5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of OCU500 via intranasal or inhalational routes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccine

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OCU500

How Is the Trial Designed?

Group I: Arm 4 Experimental Treatment 1 Intervention

A single dose of 5x10\^10 viral particles (VP) in 100 uL of OCU500 administered intranasally (0.05 mL/nostril) on Day 1 in participants from 18 to 64 years of age. N = 20

Group II: Arm 3 Experimental Treatment 1 Intervention

A single dose of 5x10\^10 viral particles (VP) in 100 uL of OCU500 administered via inhalation on Day 1 in participants from 18 to 64 years of age. N = 20

Group III: Arm 2 Experimental Treatment 1 Intervention

A single dose of 1×10\^10 viral particles (VP) in 100 uL of OCU500 administered intranasally (0.05 mL/nostril) on Day 1 in participants from 18 to 64 years of age. N = 20

Group IV: Arm 1 Experimental Treatment 1 Intervention

A single dose of 1×10\^10 viral particles (VP) in 100 uL of OCU500 administered via inhalation on Day 1 in participants from 18 to 64 years of age. N = 20

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+