NCT00856154

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

Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Peptides on autologous Dendritic Cells	10 Peptides Pulsed onto 10e7 autologous macrophage-derived maturated dendritic cells administered s.c. week 0, 2, 4, 8. 1. Gag150 RLLNAWVKV 2. Gag433 FLGKIWPV 3. Env 67 NIWATHACV 4. Pol606 KLGKAGYVV 5. Vpu66 ALVEMGHHV 6. Vif101 GLADQLIHL 7. Vif23 SLVKHHMYV 8. Gag298 KRWIILGLNKIVRMY 9. gp41 VWGIKQLQARVLAVERYLKD 10. Padre AKXVAAWTLKAAA

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2008-10-01
• First posted: 2009-03-05
• Last updated: 2009-04-08

Locations

1 site across 1 country: Denmark