A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (PARC002)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833781
First received: January 29, 2009
Last updated: March 3, 2016
Last verified: March 2016

January 29, 2009
March 3, 2016
August 2009
December 2013   (final data collection date for primary outcome measure)
  • Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) [ Time Frame: After vaccination ] [ Designated as safety issue: No ]
    Number of participants with grade 3 or 4 adverse events related to vaccination
  • Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
    Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.
The safety and tolerability of mRNA-transfected autologous dendritic cell vaccine. [ Time Frame: After each vaccination. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00833781 on ClinicalTrials.gov Archive Site
  • T Cell Proliferation [ Time Frame: Baseline to week 14 ] [ Designated as safety issue: No ]
  • IL2 and IFN Gamma Production [ Time Frame: Baseline to week 14 ]
Immune response to the vaccine. [ Time Frame: Week 4 and after the final vaccination. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy
The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.
This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infections
  • Biological: mRNA-transfected autologous dendritic cells
    Injections will be administered intradermally at weeks 0, 2, 6 and 10.
  • Biological: autologous dendritic cells with no mRNA transfection
    Injections will be administered intradermally at weeks 0, 2, 6 and 10.
    Other Name: Autologous dendritic cells not transfected with mRNA.
  • Active Comparator: mRNA-transfected dendritic cells
    Participants in this arm/group received mRNA-transfected autologous dendritic cells
    Intervention: Biological: mRNA-transfected autologous dendritic cells
  • Placebo Comparator: Dendritic cells without mRNA
    Participants in this arm/group received autologous dendritic cells with no mRNA transfection
    Intervention: Biological: autologous dendritic cells with no mRNA transfection
Gandhi RT, Kwon DS, Macklin EA, Shopis JR, McLean AP, McBrine N, Flynn T, Peter L, Sbrolla A, Kaufmann DE, Porichis F, Walker BD, Bhardwaj N, Barouch DH, Kavanagh DG. Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1 Gag and Nef: Results of a Randomized, Placebo-Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):246-53. doi: 10.1097/QAI.0000000000000852.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 positive
  • CD4+ T Cell count >200
  • Undetectable HIV viral load for 6 months prior to screening
  • On antiretroviral treatment for 12 months prior to screening

Exclusion Criteria:

  • Hepatitis C positive
  • Detectable HIV viral load within 6 months prior to study entry
  • Females who are pregnant or nursing
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833781
2008p001577, R01AI066992-04, DAIDS-ES ID 10731
Yes
Not Provided
Not Provided
Rajesh T. Gandhi, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Rajesh Gandhi, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP