MVVC (project completed)

Malaria Vectored Vaccines Consortium

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Malaria Vectored Vaccines Consortium

 

Press release 7 May 2015: Publication of promising results from a recent vaccine clinical trial in Kenya raise new hope in the fight against malaria

Background

Malaria caused by Plasmodium falciparum results in the deaths of more than half a million people every year. The majority of deaths occur in 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 lasting protection would provide the most cost-effective and long-term solution for the prevention of this deadly disease.

The European Vaccine Initiative (EVI) is coordinating the Malaria Vectored Vaccines Consortium (MVVC), a four and a half year project set up with the aim of integrating capacity-building and networking in the design and conduct of phase I and II clinical trials of viral vectored malaria vaccine candidates in East and West African adults, children, and infants. The overall objective of the project is to develop a safe, nonreactogenic, effective and affordable malariFa vaccine for use by the malaria-endemic populations of the world.

MVVC is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). The total funding provided by EDCTP is €6,500,000. This is matched by co-funding from member states (Austrian Federal Ministry of Science and Research (BM.W_Fa), Irish Aid, Medical Research Council UK (MRC UK) and Swedish International Development Cooperation Agency (Sida)) and third-party contributions. The total budget is €9,500,000.

MVVC currently consists of seven partners: EVI, University of Oxford (UOXF), Okairòs s.r.l, Centre National de Recherche et Formation sur le Paludisme (CNRFP), Kenya Medical Research Institute (KEMRI), Medical Research Council Gambia (MRC), and Université Cheikh Anta Diop (UCAD). The Vienna School of Clinical Research (VSCR) was a partner until January 2013.

MVVC tasks are divided into four work packages, each of which is headed by a designated Work Package Leader: Work Package 1: Project Management (EVI, coordinator of MVVC), Work Package 2: Clinical Trials (MRC), Work Package 3: Capacity Building (CNRFP), and Work Package 4: Networking (KEMRI).

Objectives

The research objective of the MVVC is to demonstrate the safety, efficacy and immunogenicity of a chimpanzee adenoviral vector (ChAd63)/Modified Vaccinia Ankara virus (MVA) prime-boost regime encoding the malaria antigen “multiple epitope thrombospondin-related adhesion protein” (ME TRAP), in adults in East and West Africa and in 5-17 month-old children in Burkina Faso. The project therefore includes three phase Ib clinical trials in adults, children and infants in Kenya and The Gambia and three phase IIb clinical trials in Kenya, Senegal and Burkina Faso.

The other important objective of MVVC is to build research capacity in endemic countries, and improve networking of its partners.

Major Milestones

Administrative:

• Annual consortium meetings were held in Kenya (November 2009), Burkina Faso (January 2011), The Gambia (January 2012), and Senegal (January 2013).

Clinical Trials:

• Baseline studies have been conducted at CNRFP and UCAD; epidemiological characterisation of the sites is underway.

• All three phase Ib clinical trials in adults, children and infants in Kenya and The Gambia have been successfully conducted, and the vaccine candidate shows good safety and immunogenicity.

• The phase IIb clinical trials in Kenya and Senegal have been successfully completed.

• The phase IIb clinical trial in Burkina Faso is on-going and the first interim results are awaited in Q1/Q2 2014.

• Manuscript highlighting the results of the baseline studies, the clinical trials and the funded basic recearch have been published in scientific journals, including PNAS, PLOS ONE and Journal of Immunology.  Several additional publications are in preparation.

Capacity Building & Networking:

• Capacity building includes marked infrastructure upgrades at UCAD and CNRFP as well as the training of three MSc, three PhD students and one Postdoctoral fellow, plus short-term training.  Workshops for the PhD students and finance managers and in basic and applying Good Clinical Practice, data management and protocol development have taken place in addition to a training workshop in cell-mediated immunity.  A last publication workshop took place in August 2013.

An important objective of MVVC is the promotion of capacity-building through the training of African scientists, and the development of clinical trials sites, networking, and the conduct of clinical trials.  This has led to the establishment of a well developed, stable, and sustainable infrastructure, which has enabled the formation of a network of European and African partners working together to efficiently conduct future clinical trials of new interventions.  The existence of such a network serves to greatly enhance cooperation between clinical trial sites based at African institutions, and expedite the development of a safe and effective malaria vaccine.

 

Presentations

Nicola Viebig: German Societies for Parasitology/Tropical Medicine and International Health, 14 – 17 March 2012, Heidelberg, Germany

The Malaria Vectored Vaccines Consortium: Integrating capacity building and networking in the design and conduct of Phase I and II clinical trials of viral vectored malaria vaccines in East and West African children and infants

Francis Ndungu: Kenyan Society for Immunology Annual Conference, 23 – 24 May 2012, Nairobi, Kenya

Muhammed Afolabi: 61st ASTMH Meeting, 11 - 15 November 2012, Alanta, USA

Heterologous prime-boost vaccination with ChAd63 ME-TRAP and MVA.ME-TRAP is safe and immunogenic in Gambian infants

Mansour Ndiath: Poster presentation, 61st ASTMH Meeting, 11 - 15 November 2012, Atlanta, USA

Keur Socé Health and Demographic Surveillance Site: Sites description, Base findings and policy implication

Francis Ndungu: Federation of African Immunological Societies Annual Conference, 02 – 05 December 2012, Durban, South Africa

Caroline Ogwang: EVI Rendez-vous 2012, 06 December 2012, Heidelberg, Germany

Malaria Vectored Vaccines Consortium Clinical Trials: Adults to Infants in West and East Africa

References:                                          

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Sharmila Bakshi and Egeruan Babatunde Imoukhuede. Malaria Vectored Vaccines Consortium (MVVC). Human Vaccines: Current Opinion, vol. 6, issue 6

Egeruan Babatunde Imoukhuede: Vaccine Ventures, International Innovation, Healthcare, May 2012, issue 15

 

Publications

Mol Ther. 2016 Apr 25. doi: 10.1038/mt.2016.83
Vaccine. 2016 Apr 4;34(15):1792-9. doi: 10.1016/j.vaccine.2016.02.034. Epub 2016 Feb 26
Sci Transl Med 6 May 2015: Vol. 7, issue 286, DOI: 10.1126/ scitranslmed.aaa2373
Trop Med Int Health. 2014 Jun;19(6):625-642. doi: 10.1111/tmi.12288. Epub 2014 Mar 17
Clin Vaccine Immunol. 2014 Jun; 21 (6): 901-3. doi: 10.1128/CVI.00723-13
Mol Ther. 2014 Jun 16. doi: 10.1038/mt.2014.109
Journal of Clinical Research and Bioethics. 2014;5(3):178.doi:10.4172/2155-9627.1000178
Am J Trop Med Hyg. 2014 May; 90(5): 908-14. doi: 10.4269/ajtmh.13-0615
BMJ Open. 2014 4:e004817.doi:10.1136/bmjopen-2014-004817
European Journal of Immunology, 2013 Nov. 43(11): 2919-29.  doi: 10.1002/eji.201343630 
Plos one, 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726
Immunol. 2013 Feb 1;190(3):1038-47. doi: 10.4049/jimmunol.1202438. Epub 2012 Dec 21
PLoS One. 2012;7(12):e52870. doi: 10.1371/journal.pone.0052870. Epub 2012 Dec 27
PLoS One, 2012;7(12):e52939. doi: 10.1371/journal.pone.0052939. Epub 2012 Dec 26
Proc Natl Acad Sci USA. 2012 May 22;109(21):8247-52. doi: 10.1073/pnas.1200472109. Epub 2012 May7
International Innovation, Healthcare, May 2012, issue 15
Human Vaccines: 2010, Current Opinion, vol. 6, issue 6