NCT02804711

A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

A Phase Ia Single-center, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults Aged 18-65 Years in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Before this study, there will be 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. This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an experimental recombinant staphylococcus aureus vaccine. The study will be carried out following a dose-escalation method from the low dosage to the high dosage, i.e. the higher dosage vaccine could only be administrated after the first seven-day safety of the lower dosage vaccine is confirmed after safety observation.

Conditions

• Staphylococcus Aureus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)
BIOLOGICAL	Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)
BIOLOGICAL	High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)
BIOLOGICAL	Placebo

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2016-06-17
• Last updated: 2017-10-17

Locations

1 site across 1 country: China