Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

Summary

This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to \<65 years.

Conditions

• Staphylococcal Infections

Interventions

BIOLOGICAL

SA4Ag vaccine low dose

Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.

PROCEDURE

Blood draw

Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

PROCEDURE

Colonization swab sample

Colonization swabs will be collected from all subjects at various time points throughout the study.

BIOLOGICAL

SA4Ag vaccine mid dose

Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.

PROCEDURE

Blood sample

Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

PROCEDURE

Colonization swab sample

Colonization swabs will be collected from all subjects at various time points throughout the study.

BIOLOGICAL

SA4Ag vaccine high dose

Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.

PROCEDURE

Blood draw

Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

PROCEDURE

Colonization swab sample

Colonization swabs will be collected from all subjects at various time points throughout the study.

BIOLOGICAL

Placebo

Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.

PROCEDURE

Blood draw

Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

PROCEDURE

Colonization swab sample

Colonization swabs will be collected from all subjects at various time points throughout the study.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• United States

Study Locations