80 Participants NeededMy employer runs this trial

OCU500 Vaccine for Coronavirus

Recruiting at 4 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 vaccine, OCU500, to evaluate its safety and potential effectiveness. The study examines various doses and administration methods, such as nasal or inhalation delivery. It targets individuals aged 18 to 64 who have received their COVID-19 vaccinations and a booster. Those in good health, without recent COVID-19 infection or respiratory issues, may qualify. As a Phase 1 trial, participants will be among the first to help researchers understand how this new vaccine works in people.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. However, any changes in chronic prescription medication, dose, or frequency due to deterioration of a chronic condition within 30 days before the study may affect eligibility. It's best to discuss your specific medications with the trial team to ensure they don't pose additional risks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the OCU500 vaccine, tested as both an inhaled and nasal spray treatment, is in its early testing phase, primarily focusing on safety. Although detailed safety data from this specific trial is not yet available, insights can be drawn from similar studies. Mucosal vaccines, like OCU500, are designed to trigger a strong immune response both throughout the body and at the infection site, and this approach is generally well-tolerated.

The vaccine uses a ChAd36 vector, a delivery method safely used in other vaccines. Although this trial is just starting, researchers carefully monitor for any unwanted effects from the treatment. Early trials of similar vaccines have shown they are usually well-tolerated, with side effects often being mild, such as temporary discomfort or irritation at the administration site.

As a Phase 1 trial, the main goal is to ensure safety, with any risks carefully evaluated. Participants can feel reassured by the close monitoring and gradual increase in dosage to ensure safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about OCU500, a new vaccine for COVID-19, because it offers a unique delivery method and dosage compared to existing options. Unlike traditional vaccines that are typically injected, OCU500 is administered either via inhalation or intranasally, potentially making it easier and more comfortable to receive. Additionally, it utilizes viral particles as a key component, which could enhance the immune response differently than current vaccines. These features could provide a quicker and potentially more effective way to boost immunity against the coronavirus.

What evidence suggests that this trial's treatments could be effective for coronavirus?

This trial will evaluate the OCU500 vaccine, administered either via inhalation or intranasally. Studies have shown that vaccines similar to OCU500, delivered through the nose or lungs, effectively target the virus causing COVID-19. Recipients of these similar vaccines developed more antibodies and experienced a longer-lasting immune response, even with smaller doses. These vaccines aim to enhance the body's defenses both overall and specifically at entry points like the nose and lungs. Early research suggests this method might offer broader and more effective protection against various COVID-19 variants compared to traditional vaccines. Although OCU500 is still under evaluation, its design draws on promising results from similar vaccine approaches.12678

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-64 who have already received a full COVID-19 vaccine series plus at least one booster. Participants must not be pregnant, must use approved birth control if of childbearing potential, and should be in generally good health with stable medical conditions.

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.
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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

Trial Overview

The study tests the safety and immune response of OCU500, a new COVID-19 vaccine given as either a nasal spray or inhaled mist. Two different dose levels are being tried among four groups of previously vaccinated adults.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Arm 4Experimental Treatment1 Intervention
Group II: Arm 3Experimental Treatment1 Intervention
Group III: Arm 2Experimental Treatment1 Intervention
Group IV: Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

A Safety and Immunogenicity Trial of OCU500, ChAd36 ...

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 ...

Press Release

This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19 ...

Mucosal COVID-19 vaccines in clinical development

... results from an NDV-based COVID-19 vaccine phase I trial ... Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for COVID-19.

Ocugen's OCU500 Inhaled COVID-19 Vaccine Enters ...

Louis, has shown promising results in earlier studies, including increased antibody production and sustained immune response with a lower dose ...

FDA clears IND for a Phase 1 trial of Ocugen's OCU500 ...

Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19.

ocgn-20251231

We are developing a next-generation, inhalation-based mucosal vaccine platform based on a novel ChAd vector, which includes OCU500, a COVID-19 vaccine; OCU510, ...

OCU500 Vaccine for Coronavirus

The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy ...

OCU-500 - Drug Targets, Indications, Patents

Data and Safety Monitoring Board (DSMB) recently reviewed interim safety data from Phase 2. ... OCU500 Inhaled Vaccine Candidate for COVID-19. OCU500 will be ...