NCT01364571

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

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) In Healthy Adults Aged 18 To <65 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

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 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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-06-02
• Last updated: 2019-03-04

Locations

16 sites across 1 country: United States