drugset / Trial / NCT04295070
Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers
RandomizedParallel-groupDouble-blindPrevention
Summary
This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.
Timeline
- Start
- 2020-07-10
- Primary completion
- 2021-03-06
- Completion
- 2021-05-26
Outcome
Met primary endpoint
release “Phase 1 study of CodaVax-RSV in adults 55-75 years old, which achieved its primary safety endpoint” codagenix.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CodaVax-RSV | Vaccine | — | Intranasal |