Forschungs- & Entwicklungsinformationsdienst der Gemeinschaft - CORDIS

MUVAPRED an integrated project on mucosal vaccines for poverty related diseases

Preclinical and clinical activities carried out within the Mucimm project have provided the necessary proof of principle that mucosal vaccines are feasible in humans. This successful experience and fruitful model of coordination in the field of mucosal immunity and vaccine development has created the basis to build an Integarted Project within the 6th framework programme focused on the development of mucosally delivered vaccines against HIV and TB which will induce local immunity able to neutralise the pathogens at their port of entry and systemic immunity able to prevent systemic spread of the infection. The possible development of mucosal vaccines against malaria will also be investigated.

The Project consists of two major parallel interlinked tracks:
- Phase I trials of mucosal immunization using antigens and adjuvants validated in previous preclinical and clinical studies;

- Development of new candidate vaccines for mucosal immunization and their comparative selection in animal models.

Antigens such as Gag, V2-deleted gp120, Tat of HIV-1, Ag85B/ESAT-6 hybrid molecule of TB, the C-terminal fragment of CS protein from P. berghei and P. falciparum, and adjuvants such as LTK63 and HSP70, will be used in combination for phase I trials to be performed first in Europe and than in Africa.

Development of new vaccine candidates will not include antigen discovery but would rather be based on the novel use of adjuvants and delivery systems in combination with promising antigens. Animal models of increasing relevance for human vaccines will be used to compare new candidates and to select those, which should proceed to phase I trials. The final expected result of this Project is to provide candidate mucosal vaccines, with proved safety and immunogenicity in humans, that could subsequently enter the path towards licensure through phase II and III clinical trials.

The European Developing Countries Clinical Trials Partnership (EDCTP), which is expected to be soon operative, could be instrumental in exploiting the results obtained in this project by testing mucosal vaccines against these devastating diseases in developing countries.

MUVAPRED consortium is composed of 23 partners from 10 counties including one participant form Eastern Europe (Czech Republic) and one from Developing Countries (Guinea) under the coordination of Chiron srl. These participating groups have been carefully chosen for their technical expertise and scientific excellence. So, the most excellent scientists in the field of vaccines, mucosal immunology, tuberculosis, HIV/AIDS, malaria and clinical trials will take part to this project. Thus, this project will offer the opportunity to evaluate at the same time different potential candidates and formulations for mucosal vaccination against HIV, TB and malaria bringing together technologies, molecules, and know-how that otherwise would have had little opportunities to be evaluated in the same experimental (preclinical and/or clinical) context.

The unique proposed approach of a centralised comparative testing of the vaccine candidates in animal models of increasing relevance for humans, will assure that new promising vaccine candidates will be efficiently selected. More importantly, a centralised structure will be used to perform the clinical studies with mucosal vaccines in Europe, leading to the creation of a worldwide centre of excellence for clinical studies of mucosal vaccines.

More information on the MUCIMM project can be found at: http://www.altaweb.it/mucimm/.

Reported by

CHIRON S.R.L.
VIA FIORENTINA 1
53100 SIENA
Italy
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