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

S

Statens Serum Institut

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Biological: Peptides on autologous Dendritic Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00856154
EudraCT 2006-000102-22
EudraCT2006-000102-22

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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