NCT03966040

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

A Single-center, Open-label, Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) With Different Dose in Healthy Adults Aged 18-70 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 – 70 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label phase1b clinical trial. The study will evaluate the safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day 0/0-3-7, day 0/0-7 and day 0/0-7-14.

Conditions

• Staphylococcus Aureus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7	36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
BIOLOGICAL	Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7	36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
BIOLOGICAL	Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7	36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
BIOLOGICAL	Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14	36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14

Timeline

• Start date: 2019-05-16
• Primary completion: 2019-12-16
• Completion: 2020-05-16
• First posted: 2019-05-29
• Last updated: 2021-03-30

Locations

1 site across 1 country: China