NCT01011335

Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial

A Randomized, Multi-Center Trial to Evaluate the Safety & Immunogenicity of Staphylococcus Aureus Toxoids, rAT and rLukS-PV, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.

Detailed description

Staphylococcus aureus is a leading cause of skin and soft tissue infections. Antibiotic resistance, such as seen with new community-acquired methicillin-resistant strains, presents a major challenge in treating and preventing these infections. Therefore, a preventative vaccine is considered a potentially better approach. This study assesses the safety and immunogenicity of monovalent and bivalent S. aureus vaccine components. Healthy adult subjects will be randomized to receive 1 dose of monovalent or bivalent toxoid vaccine, or placebo in a dose escalation schedule. Antigen-specific antibody will be measured by ELISA in sera collected for three months after injection. Safety data will be collected as 7 day reactogenicity diaries after each injection, adverse events and Staphylococcus aureus and skin and soft tissue infections will be collected through Day 84, and serious adverse events and chronic illnesses will be collected for the full 6 month study period. To evaluate the possible utility of booster doses, the cohort receiving the highest dose of bivalent antigen will have a 2nd dose administered at Day 84, with a new 7-day reactogenicity diary and sera collected after the 2nd dose. All subjects will be followed up with a 6 month phone call after vaccination or booster. The total subject observation period will be for 24 weeks from Day 0, plus 12 additional weeks for the cohorts that receive a 2nd dose. With a recruitment period of 4 months, the study duration is expected to be approximately 13 months.

Conditions

• Staphylococcus Aureus

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent rAT	10, 25, 50 or 100 μg
BIOLOGICAL	Monovalent rLukS-PV	10, 25, 50 or 100 μg
BIOLOGICAL	Bivalent rLukS-PV / rAT	10, 25 or 50 μg
BIOLOGICAL	Placebo with adjuvant	Placebo with adjuvant
BIOLOGICAL	Placebo	Placebo saline

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-11-11
• Last updated: 2023-03-07
• Results posted: 2017-12-12

Locations

2 sites across 1 country: United States