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

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.

Timeline

Start

2010-05

Primary completion

2011-12

Completion

2011-12

Publications

• Kloverpris HN, Jackson A, Handley A, Hayes P, Gilmour J, Riddell L, Chen F, Atkins M, Boffito M, Walker BD, Ackland J, Sullivan M, Goulder P. Non-immunogenicity of overlapping gag peptides pulsed on autologous cells after vaccination of HIV infected individuals. PLoS One. 2013 Oct 4;8(10):e74389. doi: 10.1371/journal.pone.0074389. eCollection 2013.
• Jackson A, Kloverpris HN, Boffito M, Handley A, Atkins M, Hayes P, Gilmour J, Riddel L, Chen F, Bailey-Tippets M, Walker B, Ackland J, Sullivan M, Goulder P. A randomised, placebo-controlled, first-in-human study of a novel clade C therapeutic peptide vaccine administered ex vivo to autologous white blood cells in HIV infected individuals. PLoS One. 2013 Sep 17;8(9):e73765. doi: 10.1371/journal.pone.0073765. eCollection 2013.

Drugs

Indications