Navigation path

EuroVac-III


HIV/AIDS

European Vaccine Effort Against HIV/AIDS – III
Framework programme:
5
Project number:
QLK2-CT-2002-01431
EC contribution:
€ 2 500 000
Duration:
30 months
Type:
DM
Starting date:
1 December 2002
Website:
http://www.unil.ch/central/rech/secteurs
/vaccin1.html

Keywords: HIV-1 vaccine; clade C; SFV; DNA; NYVAC; prime-boost; phase IIa clinical trial

Summary:

The clinical lots for human use of the DNA, the Semliki Forest virus (SFV) and NYVAC vaccine components, with inserts of the HIV-1 subtype C gag, pol, nef and env genes, will be produced adhering to GMP and GLP guidelines. These vaccine components are provided by the EU cluster EuroVac and EU demonstration project EuroVac-II. One hundred HIV/AIDS low risk volunteers will be included in a phase IIa trial at four clinical trial sites.  All data will be taken to a single database for quality assurance and analysis.  Repositories and databases will be set up to assure that clinical samples will be handled appropriately, documented prudently and analysed accurately. Volunteers (50 each arm) will be immunised according to 0, 4, 8 and 12 weeks prime boost schedule.  Fifty will be immunised with two dosages (2 mg) of DNA as prime and two dosages (107 pfus) of NYVAC as boost. The other 50 will be immunised with two dosages of SFV (108 particles/dose) as prime and two dosages of NYVAC (107 pfus) as boost. The technologies of choice for CD8+ CTL assays are firstly the ELISPOT assay using pooled peptides and secondly, tests for tetramer staining.  The technologies of choice for CD4+ T-cell help assays are firstly the ELISPOT assay, again using pooled peptides and secondly, antigen-specific proliferative responses using a panel of peptides.  These assays will be done on peripheral mononuclear blood cells.

Problem:

A vaccine against HIV-1/AIDS is urgently needed to slow down the current epidemic in both Africa and Asia.  The predominant subtype of HIV-1 causing the AIDS epidemic in Africa and Asia is subtype C.

Aim:

The aim is to induce T-cell immunity to gag, pol, nef and env HIV-1 proteins.

[+] Read More