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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.