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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00377494
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults, 18-50 years of age.
2. Available to participate for the duration of the study period.
3. HIV seronegative, per written proof of assay collected within four weeks of screening
4. Provision of personal (not proxy) agreement to consent to the study.
Exclusion Criteria:
1. Females who are pregnant or nursing, who plan on becoming pregnant or plan to nurse during the study period, or males who plan on fathering children during the study period.
2. Have a history of diabetes or any cardiovascular disorder
3. Have hypertension, or current treatment with anti-hypertensives.
4. Have a total cholesterol \>197.5 mg/dL.
5. Have an abnormal EKG (e.g., all kinds of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, A-V node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, or 2 premature ventricular contractions (PVC) in a row, or ST elevation consistent with ischemia).
6. Have an abnormal Troponin I level.
7. Are HIV positive or have any known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy).
8. Have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.)
9. Have or have had any other illness or condition which, in the investigator's judgment, will substantially increase the risk associated with their participation or will compromise the scientific objectives of the protocol.
10. Have eczema/atopic dermatitis or other significant skin condition.
11. Have anemia, defined by a hemoglobin level \< 12.7g/dl in males, and \< 10.5 g/dl in females.
12. Have a creatinine level \>141.2 mmol/L (males) or \>120.5 mmol/L (females).
13. Have an ALT value \>53.1 U/L in males, or \>39.2 U/L in females.
14. Have an AST value \>65.0 U/L in males, or \>46.5 U/L in females.
15. Have a total bilirubin value \> 1.4 mg/L
16. Have an alkaline phosphatase level \> 297.8 U/L in males, or \> 255.4 U/L in females.
17. Have a white cell count \<3.4 x 10(9th)/L or \> 8.8 x 10(9th)/L.
18. Have a platelet count \<97.0 x 10(9th)/L in males, or \<118.0 x 10(9th)/L in females
19. Have the presence of any glucose or greater than trace amounts of protein in the urine. Have the presence of greater than trace amounts of RBC in the urine of males and non-menstruating females.
20. Plan to have surgery between enrollment and the last immunization.
21. Have any known allergic reactions or hypersensitivity to any vaccinations in the past.
22. Decision to participate in another investigational vaccine/drug research during the period of this study.
23. Have any immunizations planned within three weeks of one of the study immunizations.
24. Receipt of immunoglobulins or any blood products within three months preceding the initial study immunization or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00377494
Study Brief:
Protocol Section:
NCT00377494