Trials / Completed
CompletedNCT04295070
Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers
A Phase 1, First in Human, Randomized, Double-blind, Placebo Controlled Study of the Safety, Tolerability, and Immunogenicity of the CodaVax-RSV Vaccine in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Codagenix, Inc · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CodaVax-RSV | Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper |
| BIOLOGICAL | Normal saline | Saline (0.9%) administered via dropper |
Timeline
- Start date
- 2020-07-10
- Primary completion
- 2021-03-06
- Completion
- 2021-05-26
- First posted
- 2020-03-04
- Last updated
- 2021-06-10
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04295070. Inclusion in this directory is not an endorsement.