Trials / Completed
CompletedNCT02820883
A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
A Single-center, Dose-escalation, Open-label Pilot Study to Evaluate the Safety and Tolerability of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention · Network
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Staphylococcus aureus vaccine (60µg/per protein) | two doses of 60µg/0.6ml per dose |
| BIOLOGICAL | Staphylococcus aureus vaccine (30µg/per protein) | two doses of 30µg/0.6ml per dose |
| BIOLOGICAL | Staphylococcus aureus vaccine (15µg/per protein) | two doses of 15µg/0.6ml per dose |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-07-01
- Last updated
- 2016-09-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02820883. Inclusion in this directory is not an endorsement.