Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
|Staphylococcus Aureus||Biological: Monovalent rAT Biological: Monovalent rLukS-PV Biological: Bivalent rLukS-PV / rAT Biological: Placebo with adjuvant Biological: Placebo||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized, Multi-Center Trial to Evaluate the Safety & Immunogenicity of Staphylococcus Aureus Toxoids, rAT and rLukS-PV, in Healthy Volunteers|
- Assessment of safety through clinical examinations, clinical laboratory results, self-reported diary reactogenicity data and adverse event reports [ Time Frame: Up to 6 months ]
- Immunogenicity: Levels of Anti-rAT and Anti-rLukS-PV [ Time Frame: Up to 4 months ]
|Study Start Date:||November 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Active Vaccine
Monovalent rAT or Monovalent rLukS-PV or Bivalent rLukS-PV / rAT
Biological: Monovalent rAT
10, 25, 50 or 100 μgBiological: Monovalent rLukS-PV
10, 25, 50 or 100 μgBiological: Bivalent rLukS-PV / rAT
10, 25 or 50 μg
|Placebo Comparator: Placebo with Alum||
Biological: Placebo with adjuvant
Placebo with adjuvant
|Placebo Comparator: Saline Placebo||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011335
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|United States, Virginia|
|Naval Medical Center Portsmouth|
|Portsmouth, Virginia, United States, 23708|
|Principal Investigator:||Michael L Landrum, MD||Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences|
|Principal Investigator:||Paul Kessler, MD||Nabi Biopharmaceuticals|