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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Peptides on autologous Dendritic Cells

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, HLA-A2, Therapeutic, Vaccine, treatment vaccine, treatment naive

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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

Sites / Locations

Rigshospitalet

Outcomes

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.

Secondary Outcome Measures

Cellular Immunity induction

Full Information

NCT ID

NCT00856154

First Posted

March 3, 2009

Last Updated

April 7, 2009

Sponsor

Statens Serum Institut

Collaborators

Hvidovre University Hospital, Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00856154

Brief Title

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

Acronym

HIVDCVac

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Statens Serum Institut

Collaborators

Hvidovre University Hospital, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Peptides on autologous Dendritic Cells

Other Intervention Name(s)

Dendritic Cells, HIV-1 Peptides

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Cellular Immunity induction

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Fomsgaard, MD DMSc

Organizational Affiliation

Statens Serum Institut

Official's Role

Study Chair

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

17550385

Citation

Thorn M, Tang S, Therrien D, Kloverpris 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. doi: 10.1111/j.1600-0463.2007.apm_595.x.

Results Reference

background

Links:

URL

http://www.laegemiddelstyrelsen.dk

Description

Danish Medicines Agency

URL

http://www.datatilsynet.dk

Description

Danish register of persons in projects

URL

http://www.ssi.dk

Description

Statens Serum Institut in Denmark (government institution)

Learn more about this trial

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

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