Dendritic Cell Vaccine in HIV-1 Infection
Recruitment status was Recruiting
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Purpose
- 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).
- To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Dendritic cell vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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). |
- Comparison of steady state viremia (so-called viral set point) after 6-12 months after vaccination with viremia before HAART.
- 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.
- 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.
- 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.
- HIV-1 specific CTL responses in lymphoid tissue
- DC Migration
- Viral load in semen and vaginal secretions
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Felipe García, MD, PhD | 34932275586 | fgarcia@clinic.ub.es |
| Spain | |
| Hospital Clínic | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Felipe García, MD, PhD 34932275586 fgarcia@clinic.ub.es | |
| Principal Investigator: Felipe García, MD, PhD | |
| Sub-Investigator: Josep M Gatell, MD, PhD | |
| Sub-Investigator: Meritxell Nomdedeu, MD, PHD | |
| Principal Investigator: | Felipe García, MD, PhD | Hospital Clínic |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Felipe García, Hospital Clinic |
| ClinicalTrials.gov Identifier: | NCT00402142 History of Changes |
| Other Study ID Numbers: | DCV-02/MANON07 |
| Study First Received: | November 17, 2006 |
| Last Updated: | March 26, 2008 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
|
HIV Infection Dendritic cell vaccine Autologous virus Heat inactivated HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013