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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV-1 Infection, HIV Infections

Intervention / Treatment
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* Biological: mRNA-transfected autologous dendritic cells
* Biological: autologous dendritic cells with no mRNA transfection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mRNA-transfected dendritic cells<br>Participants in this arm/group received mRNA-transfected autologous dendritic cells | Biological: mRNA-transfected autologous dendritic cells<br>* Injections will be administered intradermally at weeks 0, 2, 6 and 10.<br>|
| Placebo Comparator: Dendritic cells without mRNA<br>Participants in this arm/group received autologous dendritic cells with no mRNA transfection | Biological: autologous dendritic cells with no mRNA transfection<br>* Injections will be administered intradermally at weeks 0, 2, 6 and 10.<br>* Other names: Autologous dendritic cells not transfected with mRNA.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV vaccine, Dendritic cells, treatment experienced