NCT01643941

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

A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2014-03-01
• First posted: 2012-07-18
• Last updated: 2019-03-04

Locations

7 sites across 1 country: United States