A Phase 1 Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

NCT01018641 Phase 1 COMPLETED

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.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	449
Start date	2010-01
Completion	2011-07

Conditions

• Bacterial Infections
• Staphylococcal Vaccines
• Immunotherapy, Active
• Staphylococcal Skin Infections
• Staphylococcal Infections

Interventions

• SA3Ag vaccine
• Blood draw
• Colonization swab samples
• SA3Ag followed by Placebo
• Blood draw
• Colonization swab samples
• Placebo
• Blood draw
• Colonization swab samples
• SA3Ag with no booster in stage 2

Primary outcomes

• The primary immunogenicity endpoint in stage 1 is antigen-specific antibody levels using an Ig binding assay (Ig titers) 28 days after vaccination at visit 1 in the 50- to 85-year age stratum at each vaccine group (3 SA3Ag dose levels and placebo). — 1 month
• The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen. — 1 month

Countries

Australia