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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
456
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
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.
Colonization swabs will be collected from all subjects at various time points throughout the study.
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
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.
Colonization swabs will be collected from all subjects at various time points throughout the study.
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
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.
Colonization swabs will be collected from all subjects at various time points throughout the study.
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
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.
Colonization swabs will be collected from all subjects at various time points throughout the study.
Broward Research Group
Hollywood, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States
Prism Research
Saint Paul, Minnesota, United States
Buffalo Clinical Research Center, LLC
Buffalo, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
...and 6 more locations
Number and proportion of subjects reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries)
Time frame: 14 days
Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries
Time frame: 14 days
Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: 1 month (AEs), 6 months (SAEs)
Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments; number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments.
Time frame: 14 days
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine based on immunoglobulin-binding and/or opsonophagocytic activity assays.
Time frame: 1 month
Immunoglobulin concentrations for each antigen at each applicable blood sampling time point,
Time frame: various, up to 12 months
Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point,
Time frame: 1 month
Immunoglobulin geometric mean fold rise (GMFR) for each antigen
Time frame: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers
Time frame: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine at at each applicable visit
Time frame: various, up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.