Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


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