An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
Condition: Bacterial Infections; Staphylococcal Vaccines; Immunotherapy, Active; Staphylococcal Skin Infections; Staphylococcal Infections
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Bacterial Infections; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human (Phase 1) study using three dose levels of an investigational
      vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to
      assess how safe and well tolerated SA3Ag is, but will also describe the immune response over
      12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine
      on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within
      the nose and throat.
    


Intervention name(s): SA3Ag vaccine; Blood draw; Colonization swab samples; SA3Ag followed by Placebo; Blood draw; Colonization swab samples; Placebo; Blood draw; Colonization swab samples; SA3Ag with no booster in stage 2; Blood draw; Colonization swab samples; Placebo with no booster in stage 2; Blood draw; Colonization swab samples
Intervention type(s): Biological; Procedure; Procedure; Biological; Procedure; Procedure; Biological; Procedure; Procedure; Biological; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.; Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.; Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.; In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.; Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.; Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.; In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.; Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.; Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.; In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:
Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm
In stage 2 the subject will receive no vaccine.; Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.; Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.; In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.
In stage 2 the subject will receive no vaccine.; Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.; Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Staphylococcus aureus; Vaccine