NCT00856154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
Last Updated

April 8, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

March 3, 2009

Last Update Submit

April 7, 2009

Conditions

HIV Infections

Keywords

HIV-1HLA-A2TherapeuticVaccinetreatment vaccinetreatment naive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cellular Immunity induction

    12 months

Interventions

Peptides on autologous Dendritic CellsBIOLOGICAL

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

Also known as: Dendritic Cells, HIV-1 Peptides

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV positive male
  • Viral load \>1000/ml
  • CD4 count \>300
  • HLA-A2 tissue type
  • years of age
  • Able to follow the instructions
  • Informed consent

You may not qualify if:

  • Treated with other experimental vaccines or immune modulatig medicine
  • Other chronic infectious diseases
  • Allergy or autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 17550385BACKGROUND

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Anders Fomsgaard, MD DMSc

    Statens Serum Institut

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

January 1, 2007

Primary Completion

April 1, 2008

Study Completion

October 1, 2008

Last Updated

April 8, 2009

Record last verified: 2009-03

Locations

DK(1)