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

HIV Infections Clinical Trial

— HIVDCVac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856154
• Other study ID #: EudraCT2006-000102-22
• Secondary ID: EudraCT 2006-000
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2009
• Last updated: April 7, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: March 2009
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Statens Serum Institut	Hvidovre University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cellular Immunity induction		12 months	No

External Links

•   Danish Medicines Agency
•   Danish register of persons in projects
•   Statens Serum Institut in Denmark (government institution)