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Completed

NCT Number: NCT00833781

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

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.

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Key information

Conditions

HIV-1 Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Infectious Disease Unit; Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mRNA-transfected autologous dendritic cells

Biological

Injections will be administered intradermally at weeks 0, 2, 6 and 10.

autologous dendritic cells with no mRNA transfection

Biological

Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Other names: Autologous dendritic cells not transfected with mRNA.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. T Cell Proliferation

    Time frame: Baseline to week 14

  2. IL2 and IFN Gamma Production

    Time frame: Baseline to week 14

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Acronym: PARC002

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2009
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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