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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: Peptides on autologous Dendritic Cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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. Gag150 RLLNAWVKV Gag433 FLGKIWPV Env 67 NIWATHACV Pol606 KLGKAGYVV Vpu66 ALVEMGHHV Vif101 GLADQLIHL Vif23 SLVKHHMYV Gag298 KRWIILGLNKIVRMY gp41 VWGIKQLQARVLAVERYLKD Padre AKXVAAWTLKAAA|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: no changes in the blood Hemoglobin, leucocytes, trombocytes, serum sodium,potassium,creatinine,phosphatase, ALAT,ASAT, bilirubin,CRP. No dose limiting toxicity defined as unwanted events defined by CTC version 3 definition as greade 3 or more. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular Immunity induction |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, HLA-A2, Therapeutic, Vaccine, treatment vaccine, treatment naive