Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
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|ClinicalTrials.gov Identifier: NCT01011335|
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus||Biological: Monovalent rAT Biological: Monovalent rLukS-PV Biological: Bivalent rLukS-PV / rAT Biological: Placebo with adjuvant Biological: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multi-Center Trial to Evaluate the Safety & Immunogenicity of Staphylococcus Aureus Toxoids, rAT and rLukS-PV, in Healthy Volunteers|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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||
- Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports [ Time Frame: Up to 6 months ]Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary
- Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population [ Time Frame: Up to 3 months ]Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|