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Aids Vaccine Integrated Project
Framework programme:
Project number:
EC contribution:
€ 10,300,000
60 months
Starting date:
1 February 2004

Keywords: Vaccine; clinical trials; regulatory genes; developing countries; HIV; SHIV


Vaccines based on viral structural products (Env/Gag/Pol) alone have failed to prevent infection by HIV/Simian Immunodeficiency Virus (SIV). More recently, vaccines based on viral regulatory gene products (Tat/Rev/Nef) have been shown to contain virus replication and to prevent disease onset. A vaccine combining both regulatory and structural viral antigens (combined vaccine) is likely to be superior to the former since it induces immune responses to both early and late viral products. The mission of the AIDS Vaccine Integrated Project (AVIP) is to develop novel combined vaccines to be tested in phase I preventive and therapeutic trials in Europe, that are suitable for future testing in phase II/III trials in developing countries (DC), and to foster training, technology transfer and community involvement among the EU and DC. To ensure completion of the programme, priority has been given to vaccine combinations containing single antigens for which efficacy has been demonstrated in animal models and phase I studies have been completed or are ongoing.


New strategies have been recently developed aimed at blocking virus replication and disease onset in the absence of sterilising immunity. Control of virus replication may modify the virus-host interaction, favouring the host immune response, and providing protection to disease progression and virus transmission to healthy individuals. This strategy, useful for both preventive and therapeutic interventions, should include both nonstructural and structural viral products. In fact, the immune responses to the regulatory proteins Tat, Rev and Nef have been shown to play a significant role in controlling disease onset and progression. Further, with regard to Env, modifications have been introduced by partners of this consortium (i.e. deletion of the V2 loop of Env, ?V2-Env) that permit exposure of epitopes that are conserved to circumvent the clade issue. Accordingly, four different vaccine candidates have been selected in AVIP and are:

- Tat ± Env (V2-deleted)
- Nef ± Env (V2-deleted)
- HIV multigene (nef, rev, tat, gag, rt, env)
- Multi-HIV antigens/epitopes [rev, tat, nef, gag (p17, p24) full-length antigens, and over 20 T cell epitopes from Pol, Protease and Env antigens]

The efficacy of the different antigens present in the AVIP vaccine candidates has been shown in animal models and these antigens have been, or are being, tested on humans (see Table 1). Comparative analysis in both preclinical studies and phase I therapeutic and preventive trials of these vaccines will be key for the selection of vaccine candidates for phase II/III trials in DC. To this end, clinical sites have already been set up in Estonia, Finland, Germany, Italy, Sweden and the United Kingdom. Partners involved in the clinical development have wide experience with regulatory issues, good manufacturing practice (GMP) production, study design and site preparation, ethical issues and Community Advisory Board (CAB) involvement. In addition, the support of the already established Programe European Vaccine against Aids (EVA) Centralised Facility for AIDS Reagents (National Institute for Biological Standards and Control - NIBSC, UK) with repository and distribution function is of key value to this project. This will constitute an optimal basis for the standardisation of techniques and procedures, and for supporting all AVIP research, technological development and demonstration activities.

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