Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402142
Status:
COMPLETED
Last Update Posted:
2014-02-26
First Post:
2006-11-17
Brief Title:
Dendritic Cell Vaccine in HIV-1 Infection
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
2 To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy
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 1500 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 05 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 001 and significant decreases in the area under the curve of PVL rebound p 002 and in the mean peak PVL p 0004 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None