Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years

Summary

This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to \<86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to \<86 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 HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.

BIOLOGICAL

SA4Ag vaccine mid dose

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

PROCEDURE

Blood draw

Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.

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 HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.

BIOLOGICAL

SA3Ag vaccine

Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.

PROCEDURE

Blood sample

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 timepoints.

BIOLOGICAL

Placebo

Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.

PROCEDURE

Blood draw

Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 samples

Colonization swabs will be collected from all subjects at various timepoints.

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

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2013-05-31

Completion

2014-03-31

Countries

• United States

Study Locations