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A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults

NCT02820883 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-09-12

No results posted yet for this study

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

  • Staphylococcus Aureus Infection

Interventions

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

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
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02820883 on ClinicalTrials.gov