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

March 3, 2016 updated by: Rajesh T. Gandhi, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Infectious Disease Unit; Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Autologous dendritic cells not transfected with mRNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 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.
Baseline and 14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
T Cell Proliferation
Time Frame: Baseline to week 14
Baseline to week 14
IL2 and IFN Gamma Production
Time Frame: Baseline to week 14
Baseline to week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Rajesh Gandhi, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008p001577
  • R01AI066992-04 (U.S. NIH Grant/Contract)
  • DAIDS-ES ID 10731 (Other Identifier: DAIDS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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