HIV Infections Clinical Trial
Official title:
A Phase 1, Dose Escalating, Single Centre, Double Blind Study of the Safety and Immunogenicity of Opal-HIV-Gag Clade C in HIV Positive Subjects
This phase I study is the first step to determine if Opal immunotherapy may have potential
utility as a treatment for HIV. Although effective treatments for HIV infection exist, they
are limited by the requirement for life-long daily treatment, cost, side effects, and the
development of resistance.
There is a need for therapeutic approaches that induce or enhance T-cell immunity to control
HIV disease. Overlapping Peptide-pulsed Autologous Cells (Opal) is a technique where
autologous peripheral blood mononuclear cells (PBMC) or whole blood is pulsed with sets of
overlapping peptides spanning whole proteins of HIV.
Opal-HIV-Gag(c) is not for direct injection and is administered by ex vivo incubation of
whole blood or separated blood components (such as white blood cells or peripheral blood
mononuclear cells) and reinfusion.
As a practical alternative to PBMC separation and to optimise vaccine presentation during the
ex vivo incubation, a blood cell separation device will be used to separate the whole blood
and enrich the white blood cell component. The device processes whole blood in a closed,
single use disposable kit. Reconstituted Opal-HIV-Gag(c)or matching placebo will be added to
the white blood cells, incubated for one hour and reinfused into the subject. Subjects will
receive 4 administrations at 4 weekly intervals. Subjects are followed for 12 weeks after the
final administration.
Each dose group will be enrolled sequentially, with a sentinel group for each dose group.
Satisfactory safety data from each cohort, reviewed by a Data Safety Monitoring Board, will
permit dose escalation.
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