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China-HIV-VacIII


HIV/AIDS (INCO)

Phase I/II clinical testing of Clade C-based HIV-1 Candidate Vaccines in China
Framework programme:
5
Project number:
ICA4-CT-2002-10042
EC contribution:
€ 1 500 000
Duration:
36 months
Type:
RS
Starting date:
Autumn 2002

Summary:

The number of people living with HIV/AIDS in China is estimated to be >600 000 and projected to rise exponentially. Based on an in-depth characterisation of the epidemiological situation, three candidate vaccines (an innovative DNA vaccine and two different types of recombinant vaccinia viruses, encoding a synthetic, Chinese clade C (CN54) derived Env and GagPolNef polygene) will be tested in a phase I/II clinical trial in China. Ninety selected HIV negative volunteers will be vaccinated according to different prime/boost regimens and assessed for the safety and immunogenicity of the candidate vaccines. Emphasis will be put on the characterisation of (cross-clade) cellular and humoral immune responses towards different regional virus strains. The proposed project also aims to establish the necessary infrastructure for future field trials.

Objectives:

The primary goal of this study is to develop and to coordinate the capacity building in China as a prerequisite for future phase III field trials. Major objectives of the proposed project are (i) to broaden the molecular epidemiology basis, and (ii) to improve further the current candidate vaccines for upcoming vaccination trials. Another aim is to determine the safety and immunogenicity of the currently available DNA- and vaccinia virus-based vaccines encoding GagpolNef and Env antigens from a representative Chinese R5 isolate (CN54) in a phase I/II clinical trial in China. Furthermore, the capacity of a DNA priming immunisation to lower the dose of the following booster immunisations with either a non-replicating or replicating vaccinia strain will be determined. The project will also assess the immunigenicity of the suggested vaccination regimens for CD4 and CD8 T-cells and for the induction of neutralising Abs.

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