Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines. Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.

Key facts

Study ID

NCT00007332

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

330

Expected to finish

2003-04-01

Last updated by the study team

2021-10-15

Who can join

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

You may qualify if…

• Volunteers may be eligible for this study if they:
• Are HIV-negative.
• Are 18 to 60 years old.
• Have a CD4 cell count of 400 cells/mm3 or more.
• Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
• Have a normal history and physical examination.
• Are available for 12 months of follow-up for the planned duration of the study.
• Have a negative pregnancy test within 3 days prior to injections.

You may not qualify if…

• Volunteers will not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Have chronic hepatitis B.
• Are taking medications that affect the immune system.
• Have an immune system problem, any long-term illness, or any autoimmune disease.
• Have cancer, except if it has been removed with surgery and cure is likely.
• Have a physical condition, mental condition, or job or work that may interfere with the study.
• Have been suicidal, or have ever needed medicines for a serious mental condition.
• Have received certain 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 history of severe allergy or any serious reactions to vaccines.
• Have had HIV-1 vaccines in a clinical study.

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• San Francisco Dept. of Public Health, San Francisco Gen. Hosp. — San Francisco, California, United States
• San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
• Project Brave HIV Vaccine CRS — Baltimore, Maryland, United States
• Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC — Baltimore, Maryland, United States
• Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore — Baltimore, Maryland, United States
• Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
• Fenway Community Health Clinical Research Site (FCHCRS) — Boston, Massachusetts, United States
• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• Univ. of Rochester HVTN CRS — Rochester, New York, United States
• NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
• Miriam Hospital's HVTU — Providence, Rhode Island, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
• Infectious Diseases Physicians, Inc. — Annandale, Virginia, United States
• FHCRC/UW Vaccine CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.