NCT01123915

A Safety and Immunogenicity Study of 3 Doses of Opal Immunotherapy in HIV Infected People

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Opal-HIV-Gag(c) Low Dose
BIOLOGICAL	Opal-HIV-Gag(c) Medium dose
BIOLOGICAL	Opal-HIV-Gag(c) High dose
OTHER	Dimethyl Sulfoxide

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-14
• Last updated: 2018-03-22

Locations

1 site across 1 country: United Kingdom