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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00002204
Eligibility Criteria:
Inclusion Criteria
Volunteers must have:
* Good health as determined by medical history, physical examination, and clinical judgment.
* Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
* In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
* Significant acute systemic infection.
* Occupational or other responsibilities that would prevent completion of participation in the study.
* Any condition that might interfere with the evaluation of the study objectives.
Volunteers with the following prior conditions are excluded:
* History of immunodeficiency, autoimmune disease, or any serious chronic illness.
* Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
* History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
1\. Immunosuppressive medications.
* Live, attenuated vaccine within 60 days of study entry.
NOTE:
* Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions.
* Experimental agents within 30 days of study entry.
* HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.
Engaging in high-risk behavior within 6 months of study entry, i.e.:
* injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00002204
Study Brief:
Protocol Section:
NCT00002204