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 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT00027261
Eligibility Criteria:
Inclusion Criteria
Participants may be eligible for this study if they:
* Are between the ages of 18 and 60.
* Are in good general health.
* Have a CD4 count of 400 or more cells/mm3.
* Do not have hepatitis C or active hepatitis B.
* Have had a negative HIV blood test within 8 weeks prior to enrollment.
* Use approved methods of contraception.
* Have access to a participating site and are available for follow-up for 18 months.
* Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
* Give written informed consent.
Exclusion Criteria
Participants may not be eligible for this study if they:
* Are pregnant or breast-feeding.
* Have received a live vaccine within 30 days prior to enrollment.
* Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
* Have used experimental research agents within 30 days prior to enrollment.
* Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
* Have received blood products 120 days before HIV screening.
* Have received immunoglobulin 60 days before HIV screening.
* Have a history of serious harmful reactions to vaccines.
* Have a history of disease of the immune system.
* Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
* Are using or have used (within past 6 months) drugs that interfere with the immune system.
* Have a history of type I or type II diabetes.
* Have thyroid disease.
* Have unstable asthma.
* Are currently taking preventive anti-TB therapy.
* Have a seizure disorder.
* Have a bleeding disorder that was diagnosed by a physician.
* Have had their spleen removed.
* Have angioedema with serious episodes.
* Have active syphilis.
* Have hypertension.
* Have mental problems that would interfere with the protocol.
* Have any other problems that, in the judgment of the investigator, would interfere with the study.
* Have a body mass index less than 20.
* Are allergic or sensitive to egg products.
* Have active tuberculosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00027261
Study Brief:
Protocol Section:
NCT00027261