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

Phase 1

Completed

• Conditions: HIV-1 Infection; HIV Infections
• Interventions: Biological: mRNA-transfected autologous dendritic cells; Biological: autologous dendritic cells with no mRNA transfection

• Registration Number: NCT00833781
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-02-02
• Study Start: 2009-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-10-15
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Results First Posted: 2016-03-08
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mRNA-transfected dendritic cells	mRNA-transfected autologous dendritic cells	Participants in this arm/group received mRNA-transfected autologous dendritic cells
Dendritic cells without mRNA	autologous dendritic cells with no mRNA transfection	Participants in this arm/group received autologous dendritic cells with no mRNA transfection

Primary Outcome Measures

Name	Time	Method
Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)	After vaccination	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	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 Outcome Measures

Name	Time	Method
T Cell Proliferation	Baseline to week 14
IL2 and IFN Gamma Production	Baseline to week 14

Trial Locations

Locations (1)

Infectious Disease Unit; Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States