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Clinical Studies on a Multivalent Vaccine for Human Visceral Leishmaniasis

Objective

The World Health Organisation in its report on Neglected Tropical Diseases has stated that there is overwhelming evidence to show that the burden caused by many of the 17 diseases that affect more than 1billion people worldwide can be effectively controlled and, in many cases, eliminated or even eradicated. Leishmaniasis caused by Leishmania spp is one of them and poses a grave health risk to an estimated 350 million people across the world. Among the three clinical patterns of Leishmaniasis (cutaneous, mucocutaneous, and visceral), Visceral Leishmaniasis (VL), also known as kala azar is the most severe in terms of symptoms and clinical complications. If left untreated, the disease can have a fatality rate as high as 100%.Only few drugs are available in the foreseeable future for treating patients from this disease. The development of a human vaccine against Leishmania is an achievable goal.In endemic areas, the majority of infected persons do not develop clinical symptoms and past infection leads to robust immunity against reinfection. In our approach, we mimic a natural infection cycle of Leishmania, by introducing the recombinant protein LJM11 from the sand fly saliva and two other components of Leishmania infantum based on well proven effective recombinant proteins from Leishmania: KMP11 and a recombinant fusion protein SMT-NH. These components will be formulated with a strong TLR4 agonist, already tested in humans, to enhance and modulate the immune response. This innovative vaccine will be tested at the Swiss Tropical and Public Health Institute, which already has experience in conducting clinical trials with Leishmania vaccines. The phase I/II clinical trial will be immunologically monitored by experienced institutions from EU and US. A European SME would have most of the benefits of this project: it would allow to further develop a vaccine against this neglected disease and increase the possibility to out-license this vaccine for commercialization.

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /medical and health sciences/health sciences/tropical medicine

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

ETNA BIOTECH SRL
Address
Strada Vincenzo Lancia 57
95100 Catania
Italy
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 284 750
Administrative Contact
Antonio Di Mauro (Mr.)

Participants (8)

ISTITUTO SUPERIORE DI SANITA
Italy
EU contribution
€ 151 840
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
Administrative Contact
Rosa Martoccia (Dr.)
INSTITUTO DE BIOLOGIA MOLECULAR E CELULAR-IBMC
Portugal
EU contribution
€ 300 000
Address
Rua Alfredo Allen 208
4200 135 Porto
Activity type
Research Organisations
Administrative Contact
Claudia Ferreira (Dr.)
INSTITUTO DE SALUD CARLOS III
Spain
EU contribution
€ 684 000
Address
Monforte De Lemos 5
28029 Madrid
Activity type
Research Organisations
Administrative Contact
Javier Moreno (Dr.)
UNIVERSIDAD AUTONOMA DE MADRID
Spain
EU contribution
€ 154 400
Address
Calle Einstein 3 Ciudad Univ Cantoblanco Rectorado
28049 Madrid
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mª Carmen Puerta (Ms.)
AMVAC AG

Participation ended

Switzerland
EU contribution
€ 216 993,90
Address
Metallstrasse 4
6300 Zug
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marie Christine Kopkow (Ms.)
SCHWEIZERISCHES TROPEN- UND PUBLIC HEALTH-INSTITUT
Switzerland
EU contribution
€ 1 173 750
Address
Socinstrasse 57
CH-4002 Basel
Activity type
Research Organisations
Administrative Contact
Gerd Pluschke (Prof.)
MEDITOX S.R.O
Czechia
EU contribution
€ 118 124
Address
Pod Zamkem 279
28125 Konarovice
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martin Slais (Dr.)
INFECTIOUS DISEASE RESEARCH INSTITUTE
United States
EU contribution
€ 1 391 506,10
Address
Eastlake Ave E 1616 Ste 400
98102 Seattle Wa
Activity type
Research Organisations
Administrative Contact
John Argerious