MVVC 2

Malaria Vectored Vaccines Consortium 2

Background

Malaria caused by the parasite Plasmodium falciparum results in the death of more than half a million people every year.  The majority of deaths occur in young children living in sub-Saharan Africa.  While methods, such as the use of anti-malarial drugs and insecticide-treated bed-nets, exist for malaria control, there are currently no effective vaccines available.  A vaccine giving strong and long-lasting protection would provide the most cost-effective and long-term solution for the prevention of this deadly disease.

MVVC 2 is a two year project coordinated by the European Vaccine Initiative (EVI) building on the work conducted during MVVC, which has started to establish a strong network between four African and the European partners.  This network was enlarged by two new partners, and capacity building efforts will be expanded during the course of MVVC 2.

MVVC 2 is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) in response to a call launched in December 2011: “Field Trials of a New Combination Malaria Vaccine in West African Adults and Children (MVVC 2)”.  The total project budget of approximately €1.2m is provided by EDCTP, co-funding from European Union (EU) Member States (Austrian Federal Ministry of Science and Research (BM.W_Fa, to be confirmed), German Federal Ministry of Education and Research (BMBF), Irish Aid, Medical Research Council UK and Swedish International Development Cooperation Agency (Sida)) and third-party contributions.

MVVC 2 comprises nine partners: EVI, University of Oxford (UOXF), Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Kenya Medical Research Institute (KEMRI), Medical Research Council (MRC), Université Cheikh Anta Diop (UCAD), Okairòs s.r.l, Kintampo Health Research Centre (KHRC) and Novartis Vaccines and Diagnostics (NVD).  The Vienna School of Clinical Research (VSCR) was a partner until January 2013.

MVVC 2 tasks are divided into three work packages (WPs), each of which is headed by a designated WP leader: WP1: Project Management (EVI), WP2: Clinical Trials (UCAD), and WP3: Capacity Building/Networking (KEMRI).

 

Objectives

The aim of MVVC 2 is to develop a highly efficacious vaccine candidate by using adjuvanted R21 (a biosimilar of the RTS,S vaccine) in combination with the Multiple-Epitope Thrombospondin-Related Adhesion Protein (ME-TRAP) vectored vaccine candidate, which was assessed during the MVVC project.  This new combination will be tested in a first phase I/IIb clinical trial in adults in Burkina Faso.  In an additional pre-interference phase Ib clinical trial in The Gambia the prime-boost ME-TRAP vectored vaccine candidates alone will be tested in combination with the Expanded Programme on Immunization (EPI) vaccines in infants.  The overall objective of the project is therefore to develop a safe, non-reactogenic, effective and affordable malaria vaccine for use by the malaria-endemic populations of the world.

Major Milestones: 

Administrative:

  • The project was approved by EDCTP in September 2012 and the Grant Agreement was signed on 1st December 2012.  The Consortium Agreement was signed in April 2013.
  • The kick-off meeting was held on 16th January 2013 and was hosted by UCAD in Dakar, Senegal.  The 1st Annual Meeting will be hosted by KEMRI, Kenya on 15th January 2014.

Clinical Trials:

  • Phase Ib clinical trial to commence at MRC, The Gambia, in collaboration with UCAD, Senegal, in Q1 2014.
  • Phase IIb clinical trial is planned to start in CNRFP, Burkina Faso, in Q2 2014.
  • Publication of the results of the MVVC 2 clinical trials is planned.
  • Capacity Building & Networking:
  • Capacity building includes marked infrastructure upgrade at KHRC as well as short-term training in project management in clinical research and possibly in Standard Operating Procedure (SOP) writing.
  • A further objective of MVVC 2 is the continuation of capacity-building through the training of African scientists and the development of clinical trial sites, networking, and the conduct and monitoring of clinical trials.  The already established infrastructure built up during MVVC will be further developed and expanded.  The strengthening of a network of European and African partners to work together to efficiently conduct future clinical trials of new interventions is serving to greatly enhance cooperation between clinical trial sites based at African institutions and expedite the development of a safe and effective malaria vaccine.