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European network for harmonisation of malaria vaccine development

Final Report Summary - EURHAVAC (European network for harmonisation of malaria vaccine development)

Basic research in the field of malaria parasitology has allowed several research groups to discover numerous malaria antigens that may be considered for formulation as potential vaccine candidates. From this initial stage of vaccine development, a finite set of well defined guidelines are missing which support and guide the development of experimental vaccines towards a safe, efficacious, affordable and widely available malaria vaccine. Consequently, the global portfolio of experimental malaria vaccines is very unbalanced, as shown by the status of the commonly studied MSP1 and CSP antigens. In 2004, among the 90 ongoing malaria vaccine projects, these two antigens represent 40 % of the global portfolio, and 56 % of the projects in phase I clinical trials. Thus, the limited research funding available for malaria vaccine development is dispersed over several similar projects and handled by different groups without concert or collaboration resulting in a questionable cascade of phase I clinical trials. This problem is further compounded as poor clinical design provides non-comparable results due to the lack of harmonisation on design, methodology and evaluation criteria. This fragmentation is continually increasing, and is currently a major issue for global and European malaria vaccine development. Therefore, we are working in collaboration with the World Health Organisation (WHO) and the malaria vaccine community to concentrate on formulating decision making processes for supporting the development of more innovative and rationale-based vaccines that are carefully guided through design and production into clinical trials and so are not hampered by inexperience or competition.

The EURHAVAC project brought together and synergised numerous groups of global experts and organisations, from a diverse range of disciplines, in order to address the current challenges facing the development of a safe and effective malaria vaccine. The main achievements of EURHAVAC were to orchestrate and guide three workshops focusing on:

- Copenhagen workshop
Developing a set of criteria to allow the assessment / evaluation of new experimental malaria vaccines and to propose how decisions should be made on whether or not to continue their development into clinical trials.

- Brussels workshop
To report on safety assessment in pre-licensure clinical trials, highlighting weaknesses and areas in need of review.

- Siena workshop
To report on the standardisation and harmonisation of assays commonly used in the development of experimental malaria vaccines and to identify exactly what is needed to advance the field. In addition, the project disseminated the findings of each workshop in an open and accessible manner, endeavouring to reach as wide an audience as possible.

All three workshops were successfully organised and completed with a high level of engagement and interest from the vaccine development community. Three reports are now publically available and have been fed into larger ongoing EC-funded projects which are engaging the EURHAVAC recommendations and applying then in a practical way. The achievements of EURHAVAC have provided a strong foundation for larger initiatives to build upon (initiatives holding adequate funding to practically implement the findings of the EURHAVAC workshops). For example, the EC-funded OPTIMALVAC project has taken the recommendations from the Siena workshop and is now initiating the practical laboratory work to develop harmonised laboratory assays. EURHAVAC has also engaged various organisations not previously involved in the EU malaria vaccine development field (e.g. US FDA) and formed strong collaborations with numerous groups inside and outside of Europe, thus further supporting the development of a safe and efficacious malaria vaccine on a wider scale.

The reports produced by EURHAVAC were complied during a series of meetings. A panel of experts was first assembled to discuss and agree upon items for a draft agenda, to identify potential speakers for the workshops, and to prepare a provisional list of delegates to be invited to participate. Using these recommendations the EURHAVAC secretariat then compiled the agenda and invited speakers and participants. All delegates and speakers were invited to comment on the agenda. The secretariat then organised all of the necessary travel and accommodation for the experts to attend the meeting. In addition, the secretariat minuted the discussions which took place at each meeting and subsequently prepared draft reports. Experts were invited to comment on the draft reports before they were made publically available by posting on EMVI's website, as well as dissemination by publication or presentation. In addition, the secretariat engaged numerous groups (e.g. AMANET, Brighton collaboration) working in areas relevant to EURHAVAC's aims. This allowed EURHAVAC to avoid duplicating the efforts already completed and enabled the development of collaborations to strengthen and support EURHAVAC's influence.

The Brussels workshop, which reported on safety assessment in pre-licensure clinical trials, was the first known workshop discussing safety in malaria clinical trials. At the time, the Siena workshop was the most advanced effort to standardise and harmonise various malaria vaccine assays and the findings have now fed into the EC-funded OPTIMALVAC project which is supporting the laboratory development of assays and reagents as recommended at the Siena workshop. The Copenhagen workshop provided a report detailing a set of criteria that can be used to assess the quality of an experimental vaccine candidate allowing decision to be made on whether or not to continue its development through the vaccine pipeline. This is currently the most advanced and detailed set of recommendations of its kind and is currently being applied to the EC-funded EMVDA project.

The workshops provided the establishment of a collaborative environment encompassing EMVDA, the European Commission, industry, academia and WHO. Prior to the workshops, there had been extensive collaboration and contact with other organisations resulting in the strengthening of EURHAVAC's position and mission.

Another significant achievement of EURHAVAC has been in laying excellent foundations for the EC-funded INYVAX and OPTIMALVAC projects. Not only has EURHAVAC highlighted and clarified the technical issues that need to be addressed but it has also inspired and motivated many of the EURHAVAC workshop participants to become involved in the INYVAX and OPTIMALVAC projects (at no cost additional to either projects). Thus, EURHAVAC has successfully synergised with INYVAX and OPTIMALVAC, strengthening both projects and further united experts from cross disciplinary groups. In addition, the clarification of many issues by the EURHAVAC workshops has allowed both projects to initiate activities much more efficiently than would have occurred otherwise. The selection criteria from the Copenhagen workshop are currently being applied to the EC-funded project EMVDA, in order to allow the selection for funding of the most superior experimental vaccine candidates to enter into further development.

EURHAVAC has also been a pioneer in the establishment of links between European and US Food and Drug Administration (FDA) / Centers for Disease Control (CDC) efforts to standardise and harmonise within the malaria vaccine field. Two of the three workshops involved the US CDC and FDA.

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