drugset / Trial / NCT07703475
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
Phase 1
Not yet recruiting
80 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Non-randomizedSequentialOpen-labelPrevention
Summary
This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating four dose levels of RVX-sCPD9 administered IN (10\^2, 10\^3, 10\^4, 5 x 10\^4 FFU). A sample size of 80 participants (20 participants in each cohort). The primary objective is to evaluate the safety and reactogenicity of a single IN administration of 4 ascending dosages of RVX-sCPD9 in previously vaccinated healthy adults.
Timeline
- Start
- 2026-08-15
- Primary completion
- 2027-11-15
- Completion
- 2027-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RVX-sCPD9 | Vaccine | 100 unknown | Intranasal |
| Subject | RVX-sCPD9 | Vaccine | 1000 unknown | Intranasal |
| Subject | RVX-sCPD9 | Vaccine | 10000 unknown | Intranasal |
| Subject | RVX-sCPD9 | Vaccine | 50000 unknown | Intranasal |