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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00856154
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : April 8, 2009
Sponsor:
Collaborators:
Hvidovre University Hospital
Rigshospitalet, Denmark
Information provided by:
Statens Serum Institut

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Peptides on autologous Dendritic Cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Intervention Details:
  • 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
    Other Names:
    • Dendritic Cells
    • HIV-1 Peptides

Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cellular Immunity induction [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856154


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Statens Serum Institut
Hvidovre University Hospital
Rigshospitalet, Denmark
Investigators
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Study Chair: Anders Fomsgaard, MD DMSc Statens Serum Institut
More Information
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Additional Information:

Publications:

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Responsible Party: Gitte Kronborg / MD DMSc Chief Medical Doctor, Infectious Disease Department, University Hospital Hvidovre
ClinicalTrials.gov Identifier: NCT00856154    
Other Study ID Numbers: EudraCT2006-000102-22
EudraCT 2006-000102-22
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: March 2009
Keywords provided by Statens Serum Institut:
HIV-1
HLA-A2
Therapeutic
 Vaccine
treatment vaccine
treatment naive
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases