Description of the project:
Background and the problem addressed in the study
Malaria remains one of the world’s greatest public health challenges. Globally malaria affects 40% of the world’s population, causing tremendous human suffering and substantial hindrance to the economic striving of the affected endemic countries. To date there is no licensed malaria vaccine. This project aims to set out on quest for safe and efficacious malaria vaccine.
The main objective of this project is to develop malaria vaccine that is safe, efficacious, and can be integrated into the expanded programme on immunisation within African countries. This task is envisaged to be implemented in four work packages:
This package will drive clinical trials of GMZ2, improve partnerships through coordination, capacity building and networking. Through this process we aim at enhancing the capacity of AMANET as a sponsor for GCP clinical trials in Africa
This package will specifically contribute to the fight against malaria through accelerated development of candidate malaria vaccine GMZ2 through age de-escalation safety, immunogenicity and limited efficacy trials at the four African trial sites. In addition, this will develop sustainable clinical trial capability that will contribute to other clinical research activities of public health benefit in Africa
Collectively, partners involved contributes to capacity development of African sites able to undertake GCP trials through human resource training, mentorship, infrastructural development and implementation of clinical studies. The consortium mutually benefits other EDCTP African projects involved in Capacity Building in Africa to the cross-fertilisation of experience from other PRD vaccines projects (HIV, tuberculosis) or other malaria prevention tools/malaria treatment projects to the training of clinical trialists (project management, financial management, GCP training, GCLP training, monitoring training). Similarly, participation with other EDCTP projects in capacity building of Ethical review of clinical trials is also enhanced
To enhance pre-existing collaboration and information sharing among partners involved through specific project activities where a platform and modalities for new networks within the host country of the trials and the regions at large are being established. This creates attachment opportunities for sharing best research practices and enhanced networking among trial sites in Africa.
Successful implementation of this project will allow us to have an established network with efficient project management capabilities, clinical trial results from phase I and II of a promising candidate malaria vaccine and at least three PhDs and three MScs. Additionally, clinical trial sites located in five different African countries (Uganda, Gambia, Gabon, Burkina Faso and Ghana) will have sufficient infrastructure and skills to conduct malaria vaccine trials as well as vaccines for other diseases to GCP standards.
This project hopes to conclude with a safe, immunogenic candidate malaria vaccine with proof of preliminary efficacy and ready to undergo phase III clinical trial. Moreover, efficient project management capacity will also be built both at the coordinating institution and participating African institutions. The capacity of the African institutions in terms of performing GCP compliant clinical trials is also expected to improve tremendously. Moreover, we are aspiring for improvement of already existing networks within institutions participating in the consortium.
The GMZ2 consortium comprises of eight partners namely African Malaria Network Trust (AMANET) in Tanzania, Statens Serum Institut (SSI) in Denmark, Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, University of Tübingen in Germany, Albert Schweitzer Hospital in Gabon, Makerere Universit in Uganda, Medical Research Council (MRC) Laboratories in The Gambia and Navrongo Health Research Centre in Ghana. It is envisaged that the existing networks between European and African institutions participating in the consortium will be be further strengthened. In addition, new networks among participating institutions will be created. These networks will be harnessed through sharing of experience where more advanced sites will provide guidance for the less developed sites.
Relevance to the EDCTP objectives and mission
EDCTP aims to accelerate the development of new of products against HIV/AIDS, tuberculosis and malaria, with a focus on phase II and III clinical trials in sub-Saharan Africa, and the main objective of this project is development of GMZ2 malaria vaccine through a multicentre Phase IIb clinical trial in African countries, including age de-escalating clinical trials that assess safety, immunogenicity and efficacy in target populations. We hope to take our product through rigorous clinical evaluation in malaria endemic countries to produce evidence of the candidate vaccine’s safety, immunogenicity and efficacy. Furthermore, our proposed activities are very much in line with EDCTP’s initiative to integrate European national research programmes into Joint Programme activities involving at least two European member states and five African institutions under the umbrella of an existing pan-African network.
If the GMZ2 candidate malaria vaccine is proved to be safe and to have the required preliminary efficacy according to the target set in the Clinical Development Plan, we will continue developing the product through the same platform and ensure its availability for those who most need it. Moreover, the capacity built at the African institutions and the network will be crucial for further development of GMZ malaria vaccine and other products of important public health relevance in those countries.