Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LA...
Detailed Description
Although recent advances have been made in antiviral therapy for AIDS, there is no cure for HIV-1 infection or AIDS, and drug therapy is too expensive for most affected populations. The development of...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are 18-50 years old.
- Are HIV-negative.
- Are healthy and have a normal history and physical exam.
- Agree to practice abstinence or use of effective birth control for 1 month before and during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of immune deficiency, chronic illness, or autoimmune disease.
- Have received immunosuppressive medications, blood products, trial drugs, immunoglobulins, or an HIV or typhoid vaccine.
- Have a history of severe allergic reactions.
- Have had prior suicidal attempts or have a psychiatric condition or job commitments which would prevent you from completing the study.
- Have a history of cancer (unless the cancer has been successfully cured), gallbladder disease, typhoid fever, migraines or other severe headaches, cardiac valve defects, or congenital heart disease.
- Have active syphilis or tuberculosis.
- Are allergic to certain medications.
- Are pregnant or breast-feeding.
- Have household contact with infants or persons who are pregnant, immunodeficient, or HIV-positive.
- Are unavailable for 12 months of follow-up.
- Have hepatitis B.
- Have a history of injection drug use within 12 months of enrollment or have higher or intermediate risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 2000
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00000868
End Date
May 1 2000
Last Update
October 28 2021
Active Locations (1)
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1
JHU AVEG
Baltimore, Maryland, United States, 21205