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Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial

NCT01011335 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-03-07

Study results available
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Summary

This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.

Conditions

  • Staphylococcus Aureus

Interventions

BIOLOGICAL

Monovalent rAT

10, 25, 50 or 100 μg

BIOLOGICAL

Monovalent rLukS-PV

10, 25, 50 or 100 μg

BIOLOGICAL

Bivalent rLukS-PV / rAT

10, 25 or 50 μg

BIOLOGICAL

Placebo with adjuvant

Placebo with adjuvant

BIOLOGICAL

Placebo

Placebo saline

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    collaborator INDUSTRY

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Michael L Landrum, MD · Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences

  • Paul Kessler, MD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01011335 on ClinicalTrials.gov