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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856154

Acronym

HIVDCVac

Enrollment

Registered

2009-03-05

Start date

2007-01-31

Completion date

2008-10-31

Last updated

2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, HLA-A2, Therapeutic, Vaccine, treatment vaccine, treatment naive

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.

Interventions

BIOLOGICALPeptides 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Cellular Immunity induction	12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026