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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

March 3, 2009
April 7, 2009
January 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00856154 on ClinicalTrials.gov Archive Site
Cellular Immunity induction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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
Not Provided
Thorn M, Tang S, Therrien D, Kløverpris H, Vinner L, Kronborg G, Gerstoft J, Corbet S, Fomsgaard A. Sequence conservation of subdominant HLA-A2-binding CTL epitopes in HIV-1 clinical isolates and CD8+ T-lymphocyte cross-recognition may explain the immune reaction in infected individuals. APMIS. 2007 Jun;115(6):757-68.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2008
April 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00856154
EudraCT2006-000102-22, EudraCT 2006-000102-22
Yes
Gitte Kronborg / MD DMSc Chief Medical Doctor, Infectious Disease Department, University Hospital Hvidovre
Statens Serum Institut
  • Hvidovre University Hospital
  • Rigshospitalet, Denmark
Study Chair: Anders Fomsgaard, MD DMSc Statens Serum Institut
Statens Serum Institut
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP