Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): SA4Ag vaccine low dose; Blood draw; Colonization swab sample; SA4Ag vaccine mid dose; Blood draw; Colonization swab sample; SA4Ag vaccine high dose; Blood draw; Colonization swab sample; SA3Ag vaccine; Blood sample; Colonization swab sample; Placebo; Blood draw; Colonization swab samples
Intervention type(s): Biological; Procedure; Procedure; Biological; Procedure; Procedure; Biological; Procedure; Procedure; Biological; Procedure; Procedure; Biological; Procedure; Procedure
Intervention description(s): 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.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Staphylococcus aureus; vaccine; Staphylococcal infection