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

This study has been completed.
Sponsor:
Collaborators:
Hvidovre University Hospital
Rigshospitalet, Denmark
Information provided by:
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00856154
First received: March 3, 2009
Last updated: April 7, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Biological: Peptides on autologous Dendritic Cells
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Potassium
U.S. FDA Resources

Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cellular Immunity induction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856154

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

Additional Information:
European database of clinical trials  This link exits the ClinicalTrials.gov site
Danish Medicines Agency  This link exits the ClinicalTrials.gov site
Danish register of persons in projects  This link exits the ClinicalTrials.gov site
Statens Serum Institut in Denmark (government institution)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gitte Kronborg / MD DMSc Chief Medical Doctor, Infectious Disease Department, University Hospital Hvidovre
ClinicalTrials.gov Identifier: NCT00856154     History of Changes
Other Study ID Numbers: EudraCT2006-000102-22, EudraCT 2006-000102-22
Study First Received: March 3, 2009
Last Updated: April 7, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Statens Serum Institut:
HIV-1
HLA-A2
Therapeutic
 Vaccine
treatment vaccine
treatment naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013