Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Background:
Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which
control the HIV infection and results in increases in CD4 cell counts and an undetectable
viral load, many patients suffer from increased morbidity. There is evidence that presence of
antibodies against the C5 region of gp120 strongly correlates with slower disease
progression, and that loss of antibody responses to this region are associated with
progression.
Investigational product:
Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the
C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a
non-neutralizing antibody against C5 region.
Study objectives:
1. To evaluate safety of the vaccination regimens
2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell
activation markers and other immune markers.