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

• Biological: SA4Ag vaccine low dose
  Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
• Procedure: Blood draw
  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.
• Procedure: Colonization swab sample
  Colonization swabs will be collected from all subjects at various time points throughout the study.
• Biological: SA4Ag vaccine mid dose
  Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
• Procedure: Blood sample
  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.
• Biological: SA4Ag vaccine high dose
  Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
• Biological: Placebo
  Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.

• Experimental: 1
  SA4Ag vaccine low dose
  Interventions:

  • Biological: SA4Ag vaccine low dose
  • Procedure: Blood draw
  • Procedure: Colonization swab sample
• Experimental: 2
  SA4Ag vaccine mid dose
  Interventions:

  • Biological: SA4Ag vaccine mid dose
  • Procedure: Blood sample
  • Procedure: Colonization swab sample
• Experimental: 3
  SA4Ag vaccine high dose
  Interventions:

  • Biological: SA4Ag vaccine high dose
  • Procedure: Blood draw
  • Procedure: Colonization swab sample
• Placebo Comparator: 4
  Placebo
  Interventions:

  • Biological: Placebo
  • Procedure: Blood draw
  • Procedure: Colonization swab sample

• Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
• Frenck RW Jr, Creech CB, Sheldon EA, Seiden DJ, Kankam MK, Baber J, Zito E, Hubler R, Eiden J, Severs JM, Sebastian S, Nanra J, Jansen KU, Gruber WC, Anderson AS, Girgenti D. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study. Vaccine. 2017 Jan 5;35(2):375-384. doi: 10.1016/j.vaccine.2016.11.010. Epub 2016 Dec 1.

Inclusion Criteria:

• Healthy adults aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
• Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
• Ability to be contacted by telephone during study participation.
• All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.

Exclusion Criteria:

• Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
• Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
• Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
• Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through 1 month post-vaccination.
• Any contraindication to vaccination or vaccine components.
• Immunocompromised persons and subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents or long term systemic corticosteroids.
• Previous administration of S. aureus vaccination.
• Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination.
• Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
• Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation.
• Subjects who are investigational site staff members or subjects who are immediate family members (1st degree relatives) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
• Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
• For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or blood chemistry laboratory values.
• Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.