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 2026-05-04
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 range18 Years – 64 Years
SexALL
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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.\*
✓. 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
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
8
Occurrence of unsolicited adverse events (AEs).
Trial details
NCT IDNCT07536308
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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.