Vac-4-All and MRTC : Launch multi-centre Malaria Vaccine Efficacy Trial in Mali
Vac-4-All, a new vaccine development initiative, and the Malaria Research and Training Centre (MRTC), a public research and training facility of the University of Bamako in the Republic of Mali, have completed the immunizations of Malian children with MSP3, a malaria vaccine prototype which recently produced promising results in a small scale trial in Burkina Faso 1.
Malaria is one of the most prominent public health problem affecting children and pregnant women in developing countries, with nearly 2.5 Billion individuals exposed, a few hundred Millions infected, and close to 1 Million deaths per year.
The trial capitalizes on the knowledge of host-parasite immune interactions and the clinical expertise accumulated by the two groups. The partnership forged between the groups intends to develop affordable vaccines against malaria and this trial is the first of a series of trials being planned to investigate several novel malaria vaccine candidates.
800 children aged 12 – 42 months are enrolled in the multi-centre double-blind, randomised, controlled Phase IIb efficacy trial. It is designed to provide a clear-cut demonstration of the efficacy of the target antigen, MSP3, in preventing clinical malaria episodes, and the underlying immunological mechanism. With an average incidence of 3 malaria attacks per person per year in the study areas, 2,400 malaria episodes are expected in the study population each year. The children are distributed across 8 villages, which are located in 2 regions which differ by their exposure to malaria, one with seasonal transmission and the other with perennial transmission, both at very high level.
Cases will be actively followed-up over 2 years post-vaccination by a large Medical team, headed by M.Sissoko and I.Sagara, with staff stationed in dispensaries in each hamlet. Particular attention has been given to the conditions of community-based and individual informed consent and participation2, to the design and organisation of the trial, to the definition criteria for clinical malaria, and to the identification of surrogate markers of protection.
About Vac4All: Vac-4-All is a private venture dedicated to malaria vaccine development, created in 2010 by P. Druilhe, formerly Head of the Malaria Vaccine Development Laboratory at the Institut Pasteur in Paris. Its mission is address urgent public health needs by developing vaccines that can be produced in a straightforward manner and that will be affordable to the populations in under-developed countries that need it most. The Vac-4-All approach follows a rationale that capatilizes on the analysis of immunological interactions between P.falciparum (the microbe that causes Malaria) and human beings which has led to the identification of several vaccine candidate molecules, explore potential surrogate markers of protection identified by clinical investigations in humans, and uses state-of–the–art research tools to analyse results from clinical trials to rationally guide product development.
About MRTC: the Malaria Research and Training Center, at the University of Bamako, in the Republic of Mali, is one of the widest malaria research facilities on the African continent and one with long-standing experience in conducting malaria clinical trials. Headed by Professor Ogobara Doumbo, its mission is to train and promote promising Malian and African doctors and scientists to work on state-of-the-art human malaria research projects and to conduct GCP/ICH-standard clinical trials with promising prophylactic and therapeutic novel compounds which could contribute to solving the problem of malaria in Africa. It is a partnership initiative, created by the MoE and MoH of Mali with technical and funding support from diverse partners including the US NIAID/NIH, TDR/WHO, the Rockfeller Foundation, and different universities (France, Italy, USA). MRTC works in close collaboration with Mali’s National Malaria Control Program and other national public institutions and with a large number of research groups over the world. Its past contributions in this field have gained international recognition.
Further information-----------------------------------------------------------------------------------------------------------------------------------
Prof. Ogobara Doumbo, Malaria Research and Training Center (MRTC), University of Bamako, BP 1805, Point G, Bamako, Republic of Mali. Mail : okd@icermali.org Phone : +223-222-8109 Fax: +223-222-8109
Vac-4-All, a new vaccine development initiative, and the Malaria Research and Training Centre (MRTC), a public research and training facility of the University of Bamako in the Republic of Mali, have completed the immunizations of Malian children with MSP3, a malaria vaccine prototype which recently produced promising results in a small scale trial in Burkina Faso 1.
Malaria is one of the most prominent public health problem affecting children and pregnant women in developing countries, with nearly 2.5 Billion individuals exposed, a few hundred Millions infected, and close to 1 Million deaths per year.
The trial capitalizes on the knowledge of host-parasite immune interactions and the clinical expertise accumulated by the two groups. The partnership forged between the groups intends to develop affordable vaccines against malaria and this trial is the first of a series of trials being planned to investigate several novel malaria vaccine candidates.
800 children aged 12 – 42 months are enrolled in the multi-centre double-blind, randomised, controlled Phase IIb efficacy trial. It is designed to provide a clear-cut demonstration of the efficacy of the target antigen, MSP3, in preventing clinical malaria episodes, and the underlying immunological mechanism. With an average incidence of 3 malaria attacks per person per year in the study areas, 2,400 malaria episodes are expected in the study population each year. The children are distributed across 8 villages, which are located in 2 regions which differ by their exposure to malaria, one with seasonal transmission and the other with perennial transmission, both at very high level.
Cases will be actively followed-up over 2 years post-vaccination by a large Medical team, headed by M.Sissoko and I.Sagara, with staff stationed in dispensaries in each hamlet. Particular attention has been given to the conditions of community-based and individual informed consent and participation2, to the design and organisation of the trial, to the definition criteria for clinical malaria, and to the identification of surrogate markers of protection.
About Vac4All: Vac-4-All is a private venture dedicated to malaria vaccine development, created in 2010 by P. Druilhe, formerly Head of the Malaria Vaccine Development Laboratory at the Institut Pasteur in Paris. Its mission is address urgent public health needs by developing vaccines that can be produced in a straightforward manner and that will be affordable to the populations in under-developed countries that need it most. The Vac-4-All approach follows a rationale that capatilizes on the analysis of immunological interactions between P.falciparum (the microbe that causes Malaria) and human beings which has led to the identification of several vaccine candidate molecules, explore potential surrogate markers of protection identified by clinical investigations in humans, and uses state-of–the–art research tools to analyse results from clinical trials to rationally guide product development.
About MRTC: the Malaria Research and Training Center, at the University of Bamako, in the Republic of Mali, is one of the widest malaria research facilities on the African continent and one with long-standing experience in conducting malaria clinical trials. Headed by Professor Ogobara Doumbo, its mission is to train and promote promising Malian and African doctors and scientists to work on state-of-the-art human malaria research projects and to conduct GCP/ICH-standard clinical trials with promising prophylactic and therapeutic novel compounds which could contribute to solving the problem of malaria in Africa. It is a partnership initiative, created by the MoE and MoH of Mali with technical and funding support from diverse partners including the US NIAID/NIH, TDR/WHO, the Rockfeller Foundation, and different universities (France, Italy, USA). MRTC works in close collaboration with Mali’s National Malaria Control Program and other national public institutions and with a large number of research groups over the world. Its past contributions in this field have gained international recognition.
Further information-----------------------------------------------------------------------------------------------------------------------------------
Prof. Ogobara Doumbo, Malaria Research and Training Center (MRTC), University of Bamako, BP 1805, Point G, Bamako, Republic of Mali. Mail : okd@icermali.org Phone : +223-222-8109 Fax: +223-222-8109
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