Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT01011335
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males or females, DoD beneficiaries, including active duty members, 18-55 years of age.
* Negative urine pregnancy test for female subjects of child bearing potential (negative test within 24 hours prior to investigational product injection) or documented surgical sterility.
* Female subjects of child-bearing potential must use an acceptable method of birth control, as determined by the PI.
* Willingness to participate in this study as evidenced by written informed consent.
Exclusion Criteria:
* Prior receipt of S. aureus rAT or rLukS-PV
* Known S. aureus infection requiring medical treatment within the 3 months prior to investigational drug product injection
* Known active viral or bacterial infection
* Seropositivity for HIV infection
* Known or suspected abuse of prescribed or illicit drugs, or alcohol in the past year
* Use of any new medications (except oral contraceptives, over-the-counter medications, or vitamin supplements) within the 7 days prior to investigational drug product injection
* Use of investigational drugs, vaccines, or devices during the study or within the 30 days prior to each dose of investigational drug product injection, or anticipated use of such items during the study
* Use of systemic steroids (any dose) or high daily dose inhaled steroids within the last month. Use of low or medium daily dose inhaled, intranasal, or low potency topical steroid creams/ointments is allowed unless such medication was begun within the previous 7 days.
* History of a bleeding or coagulation disorder; or use of anti-coagulant medications within 7 days prior to investigational product injection
* Actively breastfeeding
* Presence of grade I or higher abnormality in laboratory or vital signs parameter at time of screening
* Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01011335
Study Brief:
Protocol Section:
NCT01011335