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

NCT03966040 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-03-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chengdu Olymvax Biopharmaceuticals Inc.

    collaborator INDUSTRY

  • PLA Army Medical University

    collaborator UNKNOWN

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Fangyue Meng, Master · Jiangsu, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2019-12-16
Completion
2020-05-16

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 NCT03966040 on ClinicalTrials.gov