The phase I clinical trial, with the EuroVacc Foundation as the sponsor, will evaluate the safety of DNA-HIV-C alone and of the prime-boost regimen of DNA-HIV-C+NYVAC-HIV-C, and to compare the immunogenicity of the prime-boost regimen to NYVAC-HIV-C alone in healthy volunteers at low risk of acquiring HIV infection. The study will recruit 40 healthy volunteers: 20 at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, and 20 at St Mary's Hospital, Imperial College London. All volunteers, male or female, should be between 18 and 55 yrs, 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. According to the principal clinical investigators Prof. Giuseppe Pantaleo of CHUV in Lausanne and Prof. Jonathan Weber of Imperial College London for the clinical studies, "if this study generates promising results, EuroVacc intends to further evaluate the vaccines in larger clinical trials."
The vaccine candidates for the trial - DNA-HIV-C and NYVAC-HIV-C - were developed within the network European Vaccine Effort against HIV/AIDS. NYVAC-HIV-C (a vaccine candidate based on poxvirus) was manufactured by sanofi pasteur - the vaccine division of Sanofi-Aventis - a
Contact: Tony Stephenson
Imperial College London