Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00856154
- Lead Sponsor
- Statens Serum Institut
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 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
- Treated with other experimental vaccines or immune modulatig medicine
- Other chronic infectious diseases
- Allergy or autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method Cellular Immunity induction 12 months
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark