A Study of the Effectiveness of an HIV Vaccine (ALVAC vCP205) to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine

Completed · Phase 1

Conditions studied: HIV Infections, HIV Seronegativity

In brief

The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.

Key facts

Study ID

NCT00001136

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2001-05-01

Last updated by the study team

2021-11-01

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 willing to use adequate birth control for 1 month before study entry and during the study.
• Have a CD4 count of at least 400 cells/mm3.
• Have a normal medical history and physical examination.
• Are available for 3 months of follow-up.
• Have participated in AVEG Protocol 014C or 022A and received all the scheduled vaccinations 24 or more months before this study, or have never participated in HIV-vaccine studies.
• Are HIV-negative within 8 weeks of study entry.
• Are negative for hepatitis B surface antigen.

You may not qualify if…

• You will not be eligible for this study if you:
• Are pregnant or breast-feeding.
• Have a history of an immune system problem, any long-term illness, or any autoimmune disease.
• Have a history of using medications which affect your immune system.
• Have a history of cancer, except if it has been removed with surgery and cure is most likely.
• Have a medical or mental condition which interferes with the study.
• Have a job or work which interferes with the study.
• Have ever attempted suicide, thought of attempting suicide, or have a severe mental condition.
• Have received 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 any history of severe allergic reactions, including reactions to vaccines.
• Have an allergy to egg products or neomycin.

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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