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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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  DAIDS-ES ID 10731 
Study First Received: January 29, 2009
Results First Received: October 15, 2015
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016