Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection (HIVDCVac)

Statens Serum Institut

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Biological: Peptides on autologous Dendritic Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00856154

EudraCT 2006-000102-22

EudraCT2006-000102-22

Details and patient eligibility

About

Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated HIV-1 infection the investigators have identified relatively immune silent immune subdominant HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about 50% of peoples in Denmark). Immunising with these conserved epitopes could induce new immunity and lower viral load so the patient will live longer before AIDS or Antiviral medicine and a lower viral load will limit spread in the population. As adjuvants the investigators used patients' own autologous Dendritic Cells generated from blood cells in vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4 T-cell immunity.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV positive male
• Viral load >1000/ml
• CD4 count >300
• HLA-A2 tissue type
• 18-50 years of age
• Able to follow the instructions
• Informed consent

Exclusion criteria

• Treated with other experimental vaccines or immune modulatig medicine
• Other chronic infectious diseases
• Allergy or autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)