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Tests treatment safety and results for COVID-19
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
ClinicalTrials.gov ID: NCT07536308
What this study is testing
What is OCU500?
OCU500 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for covid-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Provides written informed consent before initiation of any study procedures.
- Able to understand and agree to comply with planned study procedures and be available for all study visits.
- Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
- Participants of childbearing potential\ must agree to use or have practiced true abstinence\ \ or use at least one acceptable primary form of...
- Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
You likely can't join if
- Positive SARS-CoV-2 PCR at screening.
- Abnormal vital signs (Grade 1 or higher).\ \ Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) = 141 mmHg or = 89 mmHg Diastolic...
- History of SARS-CoV-2 infection within the prior 16 weeks OR receipt of any COVID-19 vaccine within the prior 16 weeks before study product...
- Participant who is pregnant or breastfeeding or less than 12 weeks post partum at the time of study product administration.
- Participant has donated blood or plasma within 4 weeks prior to study product administration, or does not agree to refrain from blood or plasma...
- Receipt of antibody or blood-derived products within 90 days before study product administration.
See the full eligibility criteria
Who can join
- Provides written informed consent before initiation of any study procedures.
- Able to understand and agree to comply with planned study procedures and be available for all study visits.
- Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
- Participants of childbearing potential\ must agree to use or have practiced true abstinence\ \ or use at least one acceptable primary form of contraception.\ \ \ \ These criteria apply to females who are in a...
- Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
- In general, good health.\ \ As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90...
- Receipt of a complete primary COVID-19 vaccine series and at least one booster\ with last vaccination at least 16 weeks before study product administration. \ Booster may be either homologous or heterologous to the...
- Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.\ \ (White Blood Cells [WBCs] with differential [diff], hemoglobin...
- Must agree to have samples stored for secondary research.
- Must complete a Test of Understanding (ToU) before enrollment by answering 90 percent of questions correctly at least once in 3 attempts.
What rules you out
- Positive SARS-CoV-2 PCR at screening.
- Abnormal vital signs (Grade 1 or higher).\ \ Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) = 141 mmHg or = 89 mmHg Diastolic blood pressure (DBP) = 91 mmHg Heart rate (HR) is = 101 beats per minute...
- History of SARS-CoV-2 infection within the prior 16 weeks OR receipt of any COVID-19 vaccine within the prior 16 weeks before study product administration.
- Participant who is pregnant or breastfeeding or less than 12 weeks post partum at the time of study product administration.
- Participant has donated blood or plasma within 4 weeks prior to study product administration, or does not agree to refrain from blood or plasma donation until Day 181.
- Receipt of antibody or blood-derived products within 90 days before study product administration.
- Any significant medical or psychiatric diseases or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.\ \ Significant self-reported or medically...
- Any respiratory disease, including but not limited to chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis, etc.
- Neurological or neurodevelopmental conditions.\ \ These conditions include: history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any...
- Cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia.
- Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.
- Any significant nasal or upper airway disease.\ \ Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear...
- Has an acute illness, as determined by the site Principal Investigator or appropriate sub-investigator within 72 hours before study product administration.\ \ An acute illness which is nearly resolved with only minor...
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen/antibody test at screening.
- Has any confirmed or suspected immunosuppressive or immunodeficient state, such as asplenia, recurrent severe infections, and chronic\ immunosuppressant medication within the past 6 months.\ \ \ Chronic meaning more...
- Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before study product administration; or is planning to receive one during the study.
- Has a history of hypersensitivity or severe allergic reaction\ to any previous licensed or unlicensed vaccine or to the candidate vaccine components. \ e.g., anaphylaxis, generalized urticaria, angioedema, other...
- History of chronic idiopathic urticaria.
- Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.
- Plan to receive a COVID-19 vaccine within the 180 days following study product administration.
- Regular use of intranasal medications, including steroids.\ \ Participant must have had no intranasal medication use for 30 days before study product administration and plans not to use intranasal medications for 30...
- History of smoking within three months before enrollment.\ \ Including cigarettes, smokeless and other tobacco products, e-cigarettes (to include vaping and Juuling products), marijuana, nicotine gum, and nicotine...
- Use of intranasal illicit drugs in the 5 years before study product administration or plans to use during the study.
- Planned international travel between study product administration and Day 29.
- Previous receipt of any adenovirus-vector vaccine by the intranasal or aerosol routes.
- Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following Intramuscular injections or venipuncture.
- Recent (within 3 months of study product administration): major surgery, \>=3 days immobility, chronic infection, or head trauma that may increase thrombosis risk.\ \ Major surgery is either abdominal or vascular, or...
- History of venous or arterial thrombosis or any known thrombophilic condition, including heparin-induced thrombocytopenia (HIT) or thrombosis.
- BMI \>/= 40kg/m\^2
- Current/planned systemic estrogen therapy, except stable transdermal estradiol, from 30 days pre-dose through end of study participation. Low-dose vaginal estrogen is permitted.
The study team makes the final eligibility decision.
Where it's taking place
- Decatur, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Galveston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Decatur, Georgia, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.