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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00007332
Eligibility Criteria:
Inclusion Criteria
Volunteers may be eligible for this study if they:
* Are HIV-negative.
* Are 18 to 60 years old.
* Have a CD4 cell count of 400 cells/mm3 or more.
* Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
* Have a normal history and physical examination.
* Are available for 12 months of follow-up for the planned duration of the study.
* Have a negative pregnancy test within 3 days prior to injections.
Exclusion Criteria
Volunteers will not be eligible for this study if they:
* Are pregnant or breast-feeding.
* Have chronic hepatitis B.
* Are taking medications that affect the immune system.
* Have an immune system problem, any long-term illness, or any autoimmune disease.
* Have cancer, except if it has been removed with surgery and cure is likely.
* Have a physical condition, mental condition, or job or work that may interfere with the study.
* Have been suicidal, or have ever needed medicines for a serious mental condition.
* Have received certain vaccines within 60 days of study entry.
* Have used experimental drugs within 30 days prior to study entry.
* Have received any blood products, such as immunoglobulin, in the last 6 months.
* Have active syphilis.
* Have active tuberculosis.
* Have history of severe allergy or any serious reactions to vaccines.
* Have had HIV-1 vaccines in a clinical study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00007332
Study Brief:
Protocol Section:
NCT00007332