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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833781
First Posted: February 2, 2009
Last Update Posted: March 8, 2016
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.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
HIV-1 Infection HIV Infections Biological: mRNA-transfected autologous dendritic cells Biological: autologous dendritic cells with no mRNA transfection Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rajesh T. Gandhi, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • T Cell Proliferation [ Time Frame: Baseline to week 14 ]
  • IL2 and IFN Gamma Production [ Time Frame: Baseline to week 14 ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mRNA-transfected dendritic cells
Participants in this arm/group received mRNA-transfected autologous dendritic cells
Biological: mRNA-transfected autologous dendritic cells
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Placebo Comparator: Dendritic cells without mRNA
Participants in this arm/group received autologous dendritic cells with no mRNA transfection
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833781


Locations
United States, Massachusetts
Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Rajesh Gandhi, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Rajesh T. Gandhi, MD, Director of Education, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833781     History of Changes
Other Study ID Numbers: 2008p001577
R01AI066992-04 ( U.S. NIH Grant/Contract )
DAIDS-ES ID 10731 ( Other Identifier: DAIDS )
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: October 15, 2015
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Rajesh T. Gandhi, MD, Massachusetts General Hospital:
HIV vaccine
Dendritic cells
treatment experienced

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases