Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how safe it is to give patients a shot that has a mixture of a vaccine and dendritic cells (DCs), a special kind of immune cell, and how safe it is to give a shot of the vaccine alone.

Current HIV vaccines have not been strong enough to give good immune responses. Research has shown that the immune response to a vaccine delivered by DCs is greater than the response without DC delivery. A5130 is a study that seeks to give good delivery of the vaccine to important immune cells of the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Keyhole-limpet hemocyanin

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-infected.

• Took 3 or more anti-HIV drugs for 3 or more months before study entry.

• Have a viral load of 400 copies/ml or less for a period of 3 months before study start and within 30 days before study start.

• Have a CD4 count of 400 cells/mm3 or more for a period of 3 months before study start and within 30 days before study start.

• Have a CD4 count of 400 cells/mm3 or more at study screening.

• Have a viral load of 50 copies/ml or less at study screening.

• Are at least 18 years old.

• Agree not to become pregnant or to impregnate during the study and for 12 weeks after the study, if able to have children.

Exclusion Criteria

Patients may not be eligible for this study if they:

• Have a short-term but intense infection or serious illness within 14 days before study start and have not completed therapy or are not clinically stable on therapy.

• Have viral load values greater than 400 copies/ml within 3 months before study start.

• Have CD4 counts less than 400 cells/mm3 within 3 months before study start.

• Have close contact with canaries through work (e.g., breeding farms, bird shops). Does not apply to pet canaries.

• Are allergic to eggs or neomycin. Have a history of serious allergic reactions including allergy-induced asthma.

• Are sensitive or allergic to study drugs.

• Use drugs or alcohol in a way that would interfere with the patients' ability to follow the study requirements.

• Have become HIV-positive within 1 year before study start.

• Are pregnant or breast-feeding.

• Have had lymph node irradiation.

• Have had any HIV vaccine.

• Have used hydroxyurea within 45 days of study start.

• Have received drugs that affect the immune system, such as corticosteriods, within 30 days before study start.

• Are allergic to shellfish. (This study has been changed to make shellfish allergy an exclusion criterion and to remove abacavir use as an exclusion criterion.)