OCU500 Vaccine for COVID-19 in Previously Vaccinated Adults
This study is testing a new COVID-19 vaccine called OCU500 in adults who have already been vaccinated. OCU500 is designed to target the Omicron XBB1.5 strain of the virus. Researchers want to see how safe OCU500 is and how well your body's immune system responds to it. The vaccine will be given either through the nose (intranasal) or by inhaling it. You might be able to join if you are between 18 and 64 years old, have completed your initial COVID-19 vaccine series, and received at least one booster shot. The study will look at any side effects and how your immune system reacts to the vaccine over 6 months. This trial is currently recruiting 80 participants.
- Study design
- This is a Phase 1, randomized, open-label, dose-escalation study involving 80 participants across four groups.
- What's involved
- You would need to provide written informed consent and be available for all study visits. The study measures safety through Day 8 and up to 6 months after receiving the study product.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events for up to 6 months after receiving the study product.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
At a glance
Conditions
Where it's being run
6 sites across 5 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Occurrence of abnormal clinical safety laboratory adverse events (AE).Through Day 8
- Occurrence of adverse events of special interest (AESI).Through 6 months post study product administration
- Occurrence of medically attended adverse events (MAAEs).Through 6 months post study product administration
- Occurrence of new-onset chronic medical conditions (NOCMCs).Through 6 months post study product administration
- Occurrence of serious adverse events (SAEs).Through 6 months post study product administration
- Occurrence of solicited local adverse events (AEs).Through Day 8
- Occurrence of solicited systemic adverse events (AEs).Through Day 8
- Occurrence of unsolicited adverse events (AEs).Through Day 29