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

NCT00856154 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-04-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Anders Fomsgaard, MD DMSc · Statens Serum Institut

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-30
Completion
2008-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856154 on ClinicalTrials.gov