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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, United States
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
Time frame: 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.
Time frame: Baseline and 14 weeks
T Cell Proliferation
Time frame: Baseline to week 14
IL2 and IFN Gamma Production
Time frame: Baseline to week 14
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