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Dendritic Cell Vaccine in HIV-1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00402142
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
  1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L).
  2. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Dendritic cell vaccine Biological: non pulsed dendritic cell untreated patients Biological: pulsed dendritic cell vaccine Biological: dendritic cell vaccine Biological: non pulsed dendritic cell vaccine Phase 1 Phase 2

Detailed Description:

Our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (MD-DC) loaded with heat-inactivated autologous HIV in 12 HIV infected patients who had been receiving highly active antiretroviral therapy (HAART) since early chronic infection. Autologous HIV was concentrated from plasma (1,500 ml) obtained by plasmapheresis after a 3-month HAART interruption (STOP1) performed 78 weeks before therapeutic immunizations, and HAART was discontinued again (STOP2) after therapeutic immunization. There was a decrease of set-point plasma viral load (PVL) >= 0.5 log after 24 weeks off HAART in 4 out of 12 patients. In addition, we observed a significant lengthening in mean doubling time of PVL rebound (p= 0.01), and significant decreases in the area under the curve of PVL rebound (p= 0.02) and in the mean peak PVL (p= 0.004) during the 12 weeks after STOP 2 compared with STOP1. This virological response was associated with a weak but significant increase in HIV-1 specific CD4 lymphoproliferative response, and with changes in HIV-1 specific CD8+ T-cell responses in peripheral blood and in lymphoid CTL cells after immunization. In lymphoid tissue, we also observed a trend towards a better control of HIV-1 replication coupled with an increase of CD4+ and CTL cells. No significant virological or immunological changes occurred in controls. We show that a therapeutic vaccine with autologous MD-DC pulsed with heat inactivated autologous HIV-1 is feasible, safe and well tolerated and elicited weak and transient cellular immune responses against HIV, associated with a partial and transient control of HIV replication in some patients.

we hypothesized that a DC vaccine pulsed with higher amount of autologous virus obtained by culture could be more effective than the vaccine we used.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Autologous Myeloid Dendritic Cells as a "Cellular Adjuvant" for a Therapeutic HIV-1 Vaccine in Early Stage HIV-1+ Patients (DCV-2).
Study Start Date : November 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pulsed dendritic cells untreated patients
Untreated patients receiving a dendritic cell based vaccine pulsed with autologous heat iactivated virus
 Biological: Dendritic cell vaccine
107 DC subcutaneous 3 doses every 2 weeks
Placebo Comparator: non pulsed dendritic cells untreated patients Biological: non pulsed dendritic cell untreated patients
107 DC subcutaneous 3 doses every 2 weeks
Active Comparator: pulsed dendritic cell treated patient
treated patients will be immunized with a dendritic cell vaccine pulsed with heat inactivated autologous virus immediately before art interruption
 Biological: pulsed dendritic cell vaccine
107 DC subcutaneous 3 doses every 2 weeks
Active Comparator: pulsed dendritic cell in treated patients
patients will be immunized with a dendritic cell vaccine pulsed with heat inactivted autologous virus immediately after interruption of art
 Biological: dendritic cell vaccine
107 DC subcutaneous 3 doses every 2 weeks
Placebo Comparator: non pulsed dendritic cells Biological: non pulsed dendritic cell vaccine
107 DC subcutaneous 3 doses every 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART. [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Proportion with evidence of HIV-specific CTL comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy. [ Time Frame: 6 and 12 months ]
  2. Proportion with evidence of HIV-specific T-cell proliferative response comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy. [ Time Frame: 6 and 12 months ]
  3. Proportion with evidence of HIV-specific neutralizing activity of serum comparing end of immune-based therapy, and end of trial (week 48) with start of immune-based therapy. [ Time Frame: 6 and 12 months ]
  4. HIV-1 specific CTL responses in lymphoid tissue [ Time Frame: 0 and 6 months ]
  5. DC Migration [ Time Frame: 0 and 2 weeks ]
  6. Viral load in semen and vaginal secretions [ Time Frame: 0 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed HIV infection
  • CD4 > 450 x 10 6 /L
  • baseline VL >10,000 c/ml before any HAART
  • Part I, patients off HAART at least during 6 months
  • Part II, Patients on HAART with PVL < 200 copies/ml at least during 6 months
  • Written informed consent .

Exclusion Criteria:

  • Patients with failure to HAART
  • Patients with B or C symptoms (CDC classification 1993).
  • Age < 18 years old.
  • Pregnant or breastfeeding women
  • Patients with baseline creatinin > 2.5 mg/dl
  • Patients with baseline GOT/GPT > 250 UI/L
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402142


Locations
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Spain
Hospital Clínic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Felipe García, MD, PhD Hospital Clínic
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Felipe Garcia, Principal investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00402142    
Other Study ID Numbers: DCV-02/MANON07
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014
Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:
HIV Infection
Dendritic cell vaccine
Autologous virus
Heat inactivated
HIV Therapeutic Vaccine
Additional relevant MeSH terms:
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Infections
HIV Infections
Communicable Diseases
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs