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

Completed · Phase 1

Conditions studied: HIV Infections, HIV Seronegativity

In brief

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 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection. This study examines a new oral vaccine to see if it can improve the immune system's ability to fight the HIV virus when given alone or with another injected vaccine.

Key facts

Study ID

NCT00000868

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

27

Expected to finish

2000-05-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• JHU AVEG — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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