Brussels, 17 Feb 2005
Following on from the success of the first phase I study, the European Vaccine Effort against HIV/AIDS (EuroVacc) has announced the start of a second series of clinical trials (EuroVacc 02) to evaluate DNA-HIV-C and NYVAC-HIV-C, two novel investigational vaccines for the prevention of HIV infection.
The two vaccines are based on HIV subtype C, a virus prevalent in China, India and sub-Saharan Africa which represents more than 50 per cent of new HIV infections worldwide. They will be tested in parallel clinical trials to take place in Lausanne, Switzerland, and London, UK.
'If this study generates promising results, EuroVacc intends to further evaluate the vaccines in larger clinical trials,' the principal clinical investigators Giuseppe Pantaleo of CHUV (Centre Hospitalier Universitaire Vaudois) in Lausanne and Jonathan Weber of Imperial College London, said jointly.
The European Commission is providing 8.85 million euro under the Fifth Framework Programme (FP5) to EuroVacc, which brings together 21 European partners and aims to develop safe and effective preventive vaccines against HIV/AIDS. The project has been in existence for over five years and has developed a pipeline of potential vaccines.
NYVAC-HIV-C, a vaccine candidate based on poxvirus, has already been successfully evaluated in a phase I study (EuroVacc 01). This trial proved that NYVAC-HIV-C is safe and immunogenic. The new trial will evaluate the safety of DNA-HIV-C alone and of the combined prime-boost regimen of DNA-HIV-C and NYVAC-HIV-C. The study will also compare the immunogenicity of the prime-boost regimen to NYVAC-HIV-C alone.
The trials will be carried out on 40 healthy volunteers: 20 in Lausanne and 20 in London. All volunteers will be between the age of 18 and 55, HIV negative and at low risk of infection.
'The trial will carefully evaluate the safety and immunogenicity of the combination of the vaccines, in particular their ability to generate HIV-specific cell-mediated immune response to HIV, which is considered to be a key determinant of protection against infection,' explained Professors Pantaleo and Weber.
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