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

NCT02804711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-10-17

No results posted yet for this study

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

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

Sponsors & Collaborators

Chengdu Olymvax Biopharmaceuticals Inc.
collaborator INDUSTRY
Third Military Medical University
collaborator OTHER
Jiangsu Province Centers for Disease Control and Prevention
lead NETWORK

Study Design

Allocation: RANDOMIZED
Purpose: PREVENTION
Masking: TRIPLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 65 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2016-09-30
Primary Completion: 2017-07-31
Completion: 2017-09-30

Countries

China

Study Locations

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Entities

Drugs

Placebo