Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections, HIV Seronegativity

In brief

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Key facts

Study ID

NCT00027261

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

110

Expected to finish

2005-12-01

Last updated by the study team

2021-10-14

Who can join

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

You may qualify if…

• Participants may be eligible for this study if they:
• Are between the ages of 18 and 60.
• Are in good general health.
• Have a CD4 count of 400 or more cells/mm3.
• Do not have hepatitis C or active hepatitis B.
• Have had a negative HIV blood test within 8 weeks prior to enrollment.
• Use approved methods of contraception.
• Have access to a participating site and are available for follow-up for 18 months.
• Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
• Give written informed consent.

You may not qualify if…

• Participants may not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Have received a live vaccine within 30 days prior to enrollment.
• Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
• Have used experimental research agents within 30 days prior to enrollment.
• Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
• Have received blood products 120 days before HIV screening.
• Have received immunoglobulin 60 days before HIV screening.
• Have a history of serious harmful reactions to vaccines.
• Have a history of disease of the immune system.
• Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
• Are using or have used (within past 6 months) drugs that interfere with the immune system.
• Have a history of type I or type II diabetes.
• Have thyroid disease.
• Have unstable asthma.
• Are currently taking preventive anti-TB therapy.
• Have a seizure disorder.
• Have a bleeding disorder that was diagnosed by a physician.
• Have had their spleen removed.
• Have angioedema with serious episodes.
• Have active syphilis.
• Have hypertension.
• Have mental problems that would interfere with the protocol.
• Have any other problems that, in the judgment of the investigator, would interfere with the study.
• Have a body mass index less than 20.

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
• UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp. — San Francisco, California, United States
• Project Brave HIV Vaccine CRS — 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 Health Sciences Ctr — St Louis, Missouri, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• Univ. of Rochester HVTN CRS — Rochester, 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

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