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Phase IIb-Test of Concept Clinical Trial of the Peptide-based HIV-1 Therapeutic Vaccine Candidate Vacc-4x

Tildelt: kr 5,0 mill.

Prosjektnummer:

185783

Prosjektperiode:

2008 - 2009

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Combination antiretroviral therapy (ART), the daily life long treatment for human immunodeficiency virus (HIV) infection is costly and associated with adverse side effects following long term use (e.g. metabolic toxicity). This study will further the cli nical development of the peptide-based HIV therapeutic vaccine candidate Vacc-4x. Therapeutic vaccination has the potential to benefit those already infected with HIV as well as to obtain valuable insight that can contribute to the development of an effec tive preventative vaccine. Sustained immune responses to the HIV core protein (p24) are associated with preservation of CD4+ T-cell counts and slowed disease progression in untreated individuals. Vacc-4x is composed of modified peptides to p24 injected i ntradermally targeting dendritic cells of the skin. Vacc-4x aims to complement ART by inducing p24-specific immune responses that can sustain CD4+ T-cell counts and control the infection during prolonged ART-free periods. The SMART study prematurely termi nated due to adverse events, challenges the safety of CART-free periods. However, the SMART study did not include any immunological support. Vacc-4x was found to be safe, immunogenic and well tolerated in a phase II clinical trial carried out in Norway. Immunized patients achieved safe prolonged ART-free periods (median 31 months). This study will initiate a larger prospective randomized double blind placebo-controlled multi-centre phase IIb-TOC (Test of Concept) clinical trial in Europe and the United S tates that aims to verify the findings from the earlier phase II clinical trial compared to a placebo control group. A successful therapeutic vaccine (giving immunological support) that can minimize ART exposure has the potential to alleviate adverse si de effects, impact on the development of resistant viruses, significantly reduce the financial burden of ART on healthcare services, and substantially improve the quality of life of infected individuals.

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GLOBHELS-Global helse