Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot get HIV from these vaccines. There are two different ways a vaccine can protect the body from infection. First, a vaccine may help the immune system make antibodies, which are proteins that recognize invading viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy infected cells. The second type of vaccine is more powerful against HIV. In this study, doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing whether they help the body make immune cells.

Key facts

Study ID

NCT00000904

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Expected to finish

1999-08-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• You may be eligible for this study if you:
• Are 18-60 years old.
• Are HIV-negative and are in good health.
• Have a CD4 count of at least 400 cells/mm3.
• Test negative for hepatitis B.
• Agree to use effective methods of 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:
• Are at high risk for being infected with HIV (risky sex behavior or injection drug use within 12 months prior to study entry).
• Have a serious medical condition, or if you have had chronic sickness, diseases of the immune system, or cancer that was not cured through surgery.
• Have a serious psychiatric condition or if you have been suicidal.
• Have a work commitment that would keep you from completing the study.
• Have syphilis or tuberculosis.
• Are allergic to eggs, neomycin, vaccines, or have ever had severe allergic reactions.
• Have taken certain medicines, including medicines that affect the immune system or experimental medicines.
• Have participated in another HIV vaccine trial.
• Have received any vaccines within 2 weeks of study entry.
• Have received a blood transfusion within 6 months prior to study entry.
• Are pregnant or breast-feeding.

Where it is running

• UAB AVEG — Birmingham, Alabama, United States
• JHU AVEG — Baltimore, Maryland, United States
• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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