OCU500 Vaccine for Coronavirus
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.12345Why 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of OCU500 via intranasal or inhalational routes
Follow-up
Participants are monitored for safety and immunogenicity after receiving the vaccine
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
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
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
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
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 ...
2.
ir.ocugen.com
ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-investigational-new-drug-application-effect/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.
4.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/ocugens-ocu500-inhaled-covid-19-vaccine-enters-phase-1-trial/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 ...
5.
oindpnews.com
oindpnews.com/2025/01/fda-clears-ind-for-a-phase-1-trial-of-ocugens-ocu500-covid-19-vaccine-via-inhalation-and-nasal-administration/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 ...
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