Autologous Dendritic Cell Vaccine in HIV1 Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous HIV-1 ApB DC Vaccine
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring dendritic cell, therapeutic vaccine, HIV-1, apoptotic cells, Phase I/II
Eligibility Criteria
Inclusion Criteria:
- Confirmed HIV-1 infection.
- CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry.
- Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry.
- Antiretroviral therapy naive.
- Willingness to interrupt ART for at least 12 weeks.
- Written informed consent.
Exclusion Criteria:
- Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period.
- Receipt of any vaccinations other than routine ones within 6 months of study entry
- Pregnancy or breastfeeding
- Previous or current CDC Category C event
- Receipt of any investigational product within 12 weeks prior to study entry.
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous HIV-1 ApB DC Vaccine
Arm Description
Subjects who will receive ApB Dendritic cell vaccine
Outcomes
Primary Outcome Measures
Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
Secondary Outcome Measures
Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)
Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption
Full Information
NCT ID
NCT00510497
First Posted
August 1, 2007
Last Updated
May 12, 2016
Sponsor
Sharon Riddler
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00510497
Brief Title
Autologous Dendritic Cell Vaccine in HIV1 Infection
Official Title
Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharon Riddler
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. It also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption.
Detailed Description
This is a phase I/II, open label, single-arm, single-site clinical trial designed to evaluate the safety and antiviral activity of the ApB DC vaccine, a therapeutic vaccine derived from autologous dendritic cells loaded with autologous HIV-1 infected apoptotic cells. The study will be conducted in three phases. The first is the pre-vaccination phase that includes study entry, isolation of autologous virus, and initiation of antiretroviral therapy. Once the patient's viral load has been suppressed to undetectable levels (<50 copies/mL) and sufficient virus has been isolated, the second phase will begin. This includes leukapheresis in order to harvest monocytes and lymphocytes necessary for vaccine preparation. Three vaccine doses will be administered subcutaneously every other week. Six weeks after the last vaccination, the third phase, analytic treatment interruption (ATI) phase, will begin. A fourth, booster dose of vaccine will be given two weeks after the start of treatment interruption. The treatment interruption will be continued for twelve weeks after which the primary HIV provider will decide whether or not antiretroviral therapy should be restarted. CD4 and viral load will be closely monitored throughout the study especially during treatment interruption. Follow-up will be continued for 24 weeks after the 12-week treatment interruption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
dendritic cell, therapeutic vaccine, HIV-1, apoptotic cells, Phase I/II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous HIV-1 ApB DC Vaccine
Arm Type
Experimental
Arm Description
Subjects who will receive ApB Dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
Autologous HIV-1 ApB DC Vaccine
Intervention Description
Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Primary Outcome Measure Information:
Title
Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.
Description
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
Time Frame
80 weeks
Secondary Outcome Measure Information:
Title
Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)
Description
Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption
Time Frame
at the end of 12 weeks treatment interruption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed HIV-1 infection.
CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry.
Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry.
Antiretroviral therapy naive.
Willingness to interrupt ART for at least 12 weeks.
Written informed consent.
Exclusion Criteria:
Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period.
Receipt of any vaccinations other than routine ones within 6 months of study entry
Pregnancy or breastfeeding
Previous or current CDC Category C event
Receipt of any investigational product within 12 weeks prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon A Riddler, MD MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26647281
Citation
Macatangay BJ, Riddler SA, Wheeler ND, Spindler J, Lawani M, Hong F, Buffo MJ, Whiteside TL, Kearney MF, Mellors JW, Rinaldo CR. Therapeutic Vaccination With Dendritic Cells Loaded With Autologous HIV Type 1-Infected Apoptotic Cells. J Infect Dis. 2016 May 1;213(9):1400-9. doi: 10.1093/infdis/jiv582. Epub 2015 Dec 8.
Results Reference
result
PubMed Identifier
19038780
Citation
Whiteside TL, Piazza P, Reiter A, Stanson J, Connolly NC, Rinaldo CR Jr, Riddler SA. Production of a dendritic cell-based vaccine containing inactivated autologous virus for therapy of patients with chronic human immunodeficiency virus type 1 infection. Clin Vaccine Immunol. 2009 Feb;16(2):233-40. doi: 10.1128/CVI.00066-08. Epub 2008 Nov 26.
Results Reference
result
Learn more about this trial
Autologous Dendritic Cell Vaccine in HIV1 Infection
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