Phase 1 Trial Evaluating Safety and Immune Response of OCU500 COVID-19 Booster Given by Nasal Spray or Inhalation in Adults Previously Vaccinated

What this Trial Is About

Researchers are evaluating the safety and immune response of OCU500, a chimpanzee adenovirus-based COVID-19 vaccine targeting the Omicron XBB1.5 spike protein. This phase 1 trial involves healthy adults aged 18 to 64 who have already completed their primary COVID-19 vaccination series and received at least one booster. The study aims to assess how safe and reactive a single dose of OCU500 is when given to these previously vaccinated adults. Participants are assigned randomly to one of four groups to receive a single dose of OCU500. The vaccine is given either via inhalation or intranasally at two different dose levels 1x1010 or 5x1010 viral particles. Each participant receives only one dose on Day 1. The trial includes 80 participants, with 20 individuals in each group, to compare the effects of the different doses and delivery methods. During the study, participants undergo safety monitoring for adverse events through Day 29 and up to 6 months after vaccination. Researchers also measure immune responses including anti-Spike antibodies in blood and nasal mucosa over 181 days. Participants complete study visits and lab tests to monitor health and immune reactions. The total study duration for each participant extends through 6 months following vaccine administration to evaluate both short- and longer-term safety and immunogenicity.

A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults