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 (PARC002)

NCT00833781 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	15
Start date	2009-08
Completion	2013-12

Conditions

• HIV-1 Infection
• HIV Infections

Interventions

• mRNA-transfected autologous dendritic cells
• autologous dendritic cells with no mRNA transfection

Primary outcomes

• 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.

Countries

United States