CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 176 enrolled
Drug / intervention
Monovalent rAT +4 morebiological
Likely dose
Monovalent rAT 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01011335
NCT01011335Phase 2Completed

A Randomized, Multi-Center Trial to Evaluate the Safety & Immunogenicity of Staphylococcus Aureus Toxoids, rAT and rLukS-PV, in Healthy Volunteers

Henry M. Jackson Foundation for the Advancement of Military Medicine·interventional·Posted Nov 11, 2009·Updated Mar 7, 2023

In Brief

A Phase 2 clinical trial evaluating Monovalent rAT, Monovalent rLukS-PV, and 3 other interventions for Staphylococcus Aureus. Completed, enrolled 176 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.6 years ago

Interventions

Monovalent rATbiological

10, 25, 50 or 100 μg

Monovalent rLukS-PVbiological

10, 25, 50 or 100 μg

Bivalent rLukS-PV / rATbiological

10, 25 or 50 μg

Placebo with adjuvantbiological

Placebo with adjuvant

Placebobiological

Placebo saline