This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to \<86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to \<86 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
284
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.
Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swabs will be collected from all subjects at various timepoints.
Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 timepoints.
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
PMG Research of Raleigh, LLC
Cary, North Carolina, United States
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Number and proportion of subjects reporting solicited 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
Time frame: 14 days
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 vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding and/or opsonphagocytic activity assays
Time frame: 1 month
Immunoglobulin titers measured as geometric mean titers for each antigen at each applicable blood sampling time point, as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Time frame: various, up to 12 months
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates at each applicable blood sampling time point.
Time frame: various, up to 12 months
Immunoglobulin geometric mean fold rise for each of the vaccine components as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Time frame: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers against S. aureus isolates.
Time frame: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results ≥ thresholds defined for each vaccine component at each applicable visit.
Time frame: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in immunoglobulin titers from baseline to each applicable visit after vaccination for each antigen.
Time frame: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in opsonophagocytic activity titers against S. aureus isolates from baseline to each applicable visit after vaccination.
Time frame: Various, up to 12 months
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