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.
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.***
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.
Sequential
OCU500
Biological/VaccineOCU500 is a monovalent, replication-defective, chimpanzee adenovirus (ChAd36)-vectored COVID-19 vaccine that encodes a codon-optimized, stabilized prefusion form of the spike (S) protein from the Omicron XBB1.5 strain.
Occurrence of abnormal clinical safety laboratory adverse events (AE).
Occurrence of adverse events of special interest (AESI).
Occurrence of medically attended adverse events (MAAEs).
Occurrence of new-onset chronic medical conditions (NOCMCs).
Level of anti-vector antibodies
SARS-CoV-2 anti-spike nasal mucosal binding Immunoglobulin A (IgA)
SARS-CoV-2 anti-spike nasal mucosal binding Immunoglobulin G (IgG)
SARS-CoV-2 anti-spike serum binding Immunoglobulin A (IgA) antibody
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