An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines. There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.

Key facts

Study ID

NCT00027365

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

84

Expected to finish

2003-06-01

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 18 and 60 years of age.
• Are in good general health and meet laboratory test requirements.
• Have a CD4 count of 400 or more cells/mm3.
• Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
• Have access to a participating site and are willing to have follow-up for the entire study (12 months).
• Answer questions about their understanding of the study.
• Do not have hepatitis B or C.
• Are HIV-uninfected.

You may not qualify if…

• Participants may not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Have recently received a vaccine.
• Have used experimental agents within 30 days before enrollment.
• Have received HIV vaccines or placebo in a previous HIV vaccine study.
• Have received blood products 120 days before HIV screening.
• Have received immunoglobulin (antibodies) 60 days before HIV screening.
• Have serious reactions to vaccines.
• Have problems with their immune system.
• Have cancer.
• Have used drugs that affect the immune system within the past 6 months.
• Have diabetes.
• Have a thyroid disease.
• Have unstable asthma.
• Are taking anti-tuberculosis drugs.
• Have seizures.
• Have a bleeding disorder.
• Have had their spleen removed.
• Have angioedema (a certain type of body tissue swelling).
• Have active syphilis.
• Have high blood pressure (unless controlled by medication).
• Have mental or emotional problems that make them unsuitable for the study.
• Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study.
• Have reactions to components of the vaccines.
• Are at high risk for contracting HIV.

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
• Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore — Baltimore, Maryland, 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. School of Medicine, HVTU — St Louis, Missouri, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• HIV Prevention & Treatment 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

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