Table 1.

Description of Study Activities and Timeline for a Phase 2 S. aureus Vaccine Trial among US Army Infantry Trainees at Fort Benning, Georgia

	Study Day / Visit Number
	−3	0	14	28	56	90	180 (e)	SSTI
	1	2	3	4	5	6	N/A	N/A
Study Activity
Recruitment and enrollment	•
Assessment of subject eligibility	•
Obtain medical history and current medications	•
Perform directed physical examination	•		•
Verification of subject eligibility		•
Obtain vital signs (pre- and post-vaccination)		•
Randomization followed by administration of study vaccine		•
Administer risk factor and personal hygiene survey	•		•	•	•	•		•
Record medications	•		•	•	•	•	•	•
Collect pre-vaccination blood for safety laboratory assays		•
Collect post-vaccination blood for safety laboratory assays			•
Record solicited adverse events			•
Collect memory aid, if applicable			•
Record unsolicited adverse events			•	•				•
Record AESIs and SAEs			•	•	•	•	•	•
Obtain interval medical history			•	•	•	•	•	•
Immunology Endpoints
Collect serum for antibody assays	•		•	•	•	•		•
Collect whole blood for T-cell assays	•		•
Collect saliva for antibody assays	•		•		•
Microbiology Endpoints
Collect nasal and throat swabs	•		•	•	•	•		•
Collect wound swab								•

SSTI: skin and soft tissue infection; N/A: not applicable; AESI: adverse event of special interest; SAE: serious adverse event