NCT01018641

An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

A Phase 1 Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.

Conditions

• Bacterial Infections
• Staphylococcal Vaccines
• Immunotherapy, Active
• Staphylococcal Skin Infections
• Staphylococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	SA3Ag vaccine	In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.
PROCEDURE	Blood draw	Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
PROCEDURE	Colonization swab samples	Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
BIOLOGICAL	SA3Ag followed by Placebo	In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.
PROCEDURE	Blood draw	Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
PROCEDURE	Colonization swab samples	Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
BIOLOGICAL	Placebo	In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.
PROCEDURE	Blood draw	Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
PROCEDURE	Colonization swab samples	Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
BIOLOGICAL	SA3Ag with no booster in stage 2	In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive no vaccine.
PROCEDURE	Blood draw	Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
PROCEDURE	Colonization swab samples	Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
PROCEDURE	Placebo with no booster in stage 2	In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl. In stage 2 the subject will receive no vaccine.
PROCEDURE	Blood draw	Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
PROCEDURE	Colonization swab samples	Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-07-01
• First posted: 2009-11-23
• Last updated: 2014-04-24

Locations

5 sites across 1 country: Australia