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

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

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.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-01-31

Completion

2011-07-31

Countries

• Australia

Study Locations