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

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: NCT00833781
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE February 2, 2009
Results First Submitted Date  ICMJE October 15, 2015
Results First Posted Date  ICMJE March 8, 2016
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) [ Time Frame: After vaccination ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2009)		 The safety and tolerability of mRNA-transfected autologous dendritic cell vaccine. [ Time Frame: After each vaccination. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • T Cell Proliferation [ Time Frame: Baseline to week 14 ]
  • IL2 and IFN Gamma Production [ Time Frame: Baseline to week 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2009)		 Immune response to the vaccine. [ Time Frame: Week 4 and after the final vaccination. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1 Infection
  • HIV Infections
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2014)		 15
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2009)		 21
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00833781
Other Study ID Numbers  ICMJE 2008p001577
R01AI066992-04 ( U.S. NIH Grant/Contract )
DAIDS-ES ID 10731 ( Other Identifier: DAIDS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rajesh T. Gandhi, MD, Massachusetts General Hospital
Original Responsible Party Rajesh Gandhi, MD, Massachusetts General Hospital
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Rajesh Gandhi, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2016

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