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

Primary Purpose

HIV-1 Infection, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-transfected autologous dendritic cells
autologous dendritic cells with no mRNA transfection
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV vaccine, Dendritic cells, treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Infectious Disease Unit; Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mRNA-transfected dendritic cells

Dendritic cells without mRNA

Arm Description

Participants in this arm/group received mRNA-transfected autologous dendritic cells

Participants in this arm/group received autologous dendritic cells with no mRNA transfection

Outcomes

Primary Outcome Measures

Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
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
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
IL2 and IFN Gamma Production

Full Information

First Posted
January 29, 2009
Last Updated
March 3, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00833781
Brief Title
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
Acronym
PARC002
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, HIV Infections
Keywords
HIV vaccine, Dendritic cells, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-transfected dendritic cells
Arm Type
Active Comparator
Arm Description
Participants in this arm/group received mRNA-transfected autologous dendritic cells
Arm Title
Dendritic cells without mRNA
Arm Type
Placebo Comparator
Arm Description
Participants in this arm/group received autologous dendritic cells with no mRNA transfection
Intervention Type
Biological
Intervention Name(s)
mRNA-transfected autologous dendritic cells
Intervention Description
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Intervention Type
Biological
Intervention Name(s)
autologous dendritic cells with no mRNA transfection
Other Intervention Name(s)
Autologous dendritic cells not transfected with mRNA.
Intervention Description
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Primary Outcome Measure Information:
Title
Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
Description
Number of participants with grade 3 or 4 adverse events related to vaccination
Time Frame
After vaccination
Title
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef
Description
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.
Time Frame
Baseline and 14 weeks
Secondary Outcome Measure Information:
Title
T Cell Proliferation
Time Frame
Baseline to week 14
Title
IL2 and IFN Gamma Production
Time Frame
Baseline to week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Gandhi, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Disease Unit; Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26379068
Citation
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.
Results Reference
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A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects

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