A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via … (NCT07536308) | Clinical Trial Compass
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
United States80 participantsStarted 2026-05-26
Plain-language summary
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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.\*\*\*
. 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.\*
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial, safety is still being established — what does that mean for my personal risk if I were to consider participating, especially since the vaccine is delivered directly into the nose and lungs rather than by injection?
2This trial is specifically enrolling adults who have already been vaccinated against COVID-19 — given my current vaccination history, would I even be eligible to participate, and how might my previous immune responses affect what happens in this study?
3The trial is measuring a wide range of adverse events, including serious ones and new chronic medical conditions — based on what's known about this type of viral vector vaccine, what side effects would you consider most important for me to watch for?
4How does getting a vaccine through the nose or by inhalation compare in terms of safety and immune response to the standard injected COVID vaccines I've already received, and is there anything about that delivery method that concerns you for someone in my situation?
5Given that this is an early-phase safety study and standard COVID vaccines are already available, is there a medical reason it might make more sense for me to pursue an existing approved booster rather than enrolling in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of abnormal clinical safety laboratory adverse events (AE).
Timeframe: Through Day 8
2
Occurrence of adverse events of special interest (AESI).
Timeframe: Through 6 months post study product administration
3
Occurrence of medically attended adverse events (MAAEs).
Timeframe: Through 6 months post study product administration
4
Occurrence of new-onset chronic medical conditions (NOCMCs).
Timeframe: Through 6 months post study product administration
5
Occurrence of serious adverse events (SAEs).
Timeframe: Through 6 months post study product administration
6
Occurrence of solicited local adverse events (AEs).
Timeframe: Through Day 8
7
Occurrence of solicited systemic adverse events (AEs).
Timeframe: Through Day 8
Trial details
NCT IDNCT07536308
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.
. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.\*
Exclusion criteria
. Must agree to have samples stored for secondary research.
0. Must complete a Test of Understanding (ToU) before enrollment by answering 90 percent of questions correctly at least once in 3 attempts.
. Positive SARS-CoV-2 PCR at screening.
. Abnormal vital signs (Grade 1 or higher).\*
. 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.