Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

Subject Recruitment: EVOGUARDStudy.com/ct Inclusion Criteria:

• Subjects must meet both of the following criteria:

1. Urogenital CT and/or GC infection (documented in a retrievable medical record)within the 16 weeks prior to enrollment and one or more of the additional riskfactors included below:

• 18 to 24 years of age at the screening visit
• New sex partner within the past 12 weeks (84 days)
• More than one current sex partner
• Knowledge that current sex partner has multiple partners
• Partner with known sexually transmitted infection (STI)
• Inconsistent condom use among persons who are not in a mutually monogamousrelationship

2. After three unsuccessful documented attempts to obtain medical records, thesubject has a self-reported history of infection less than 17 weeks prior toenrollment AND two or more of the following additional risk factors:

• 18 to 24 years of age at the screening visit
• New sex partner within the past 12 weeks (84 days)
• More than one current sex partner
• Knowledge that current sex partner has multiple partners
• Partner with known STI
• Inconsistent condom use among persons who are not in a mutually monogamousrelationship
• Ability to understand the consent process and procedures. For minors, the ability toobtain consent from parents/legal guardian and assent by minor subjects as applicableaccording to local regulations.
• Agree to be available for all study visits including Visit 5 and follow-up Visit 6 andcomply with follow-up on staff appointment reminders
• Negative pregnancy test
• Negative CT and GC nucleic acid amplification test (NAAT) at screening or positive CTor GC NAAT and receives standard of care (SOC according to CDC or World HealthOrganization [WHO] guidelines) treatment prior to enrollment with subsequent negativeCT and GC NAAT testing at enrollment visit
• Agree to use a woman-controlled method of contraception that is not directly deliveredto the vaginal mucosa (with the exception of a vaginal ring) throughout the durationof the study, such as oral contraceptives, birth control implants, intrauterinedevices (IUDs), or tubal ligation. Condom use only is not an acceptable form ofcontraception for this study
• Able and willing to comply with all study procedures, including the use of eDiariesand reporting of all Adverse Events and concomitant medications.
• Reports vaginal sexual intercourse with a male partner at least three times per monthin the previous month and anticipates vaginal sexual intercourse regularly for theduration of the study
• Agree to abstain from douching or any form of vaginal suppository use (other thaninvestigational product) during course of study

Exclusion Criteria:

• In the opinion of the Investigator, has a history of substance or alcohol abuse in thelast 12 months or, has issues, conditions, or concerns that may compromise the safetyof the subject, impact the subject's compliance with the protocol requirements, orconfound the reliability of the data acquired
• Women who have undergone a total hysterectomy (had uterus and cervix removed).However, women with subtotal hysterectomy with an intact cervix may be enrolled
• Has a history or expectation of noncompliance with medications or interventionprotocol
• Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginalsuppository or intravaginal device (with the exception of contraceptive vaginal ringor tampons) for 24 hours prior to enrollment (may be enrolled at a later date if allother criteria are met)
• Menstruating at enrollment (may be enrolled at a later date if all other criteria aremet)
• Is currently being treated, or has been treated, for a period of 21 days prior toenrollment, with any prohibited antibiotics. The prohibited antibiotics includeazithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, andcefixime.
• In the opinion of the Investigator, has signs/symptoms that indicate persistence of CTor GC infection diagnosed at screening, new interval infection, and/or a failure tocomply with or complete the prescribed treatment regimen following a positivescreening NAAT