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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01397604
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests
2. Age of at least 18 years of age on the day of screening and no greater than 60 years at time of administration
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks)
4. Willing to undergo HIV testing and counseling and receive HIV test results
5. If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) throughout until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time.
Exclusion Criteria:
1. Confirmed HIV-1 or HIV-2 infection
2. Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease
3. Any use of systemic corticosteroids immunosuppressive anticancer medications
4. Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
5. Any laboratory value outside of reference range other than CRP, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee.
6. Within the 12 months prior to enrollment, the subject self reports excessive daily alcohol use, frequent binge drinking or chronic marijuana abuse (defined as greater than 2 times a week) or any other use of illicit drugs
7. Positive hepatitis B surface antigen, positive hepatitis C antibodies, or active syphilis infection based on clinical evaluation;
8. If female, pregnant, planning a pregnancy during the trial period, or lactating
9. Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug
10. Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study
11. In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons
12. Allergy to eggs
13. A glomerular filtration rate that is less than 60mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01397604
Study Brief:
Protocol Section:
NCT01397604