ZIKAlliance is a multidisciplinary project with a global "One Health" approach, built on (i) a multi‐centric network of clinical cohorts in the Caribbean, Central and South America; (ii) associated research sites in countries where the virus has been or is currently circulating (Africa, Asia, Polynesia) or at high risk for emergence (Reunion Island); (iii) a strong network of European and Brazilian clinical and basic research institutions; (iv) multiple interfaces with other scientific and public health programmes. Twelve Work Packages have been designed to address the 4 key objectives, as summarised in the figure below (this includes WP10, 11 & 12 in common with ZikaPLAN and ZIKAction). A 13th one has been added on request by the European Commission in order to set out the “ethics requirements” the project must comply with.
In addition, a toolbox of biological resources (e.g., viral strains, antigens, antibodies) and techniques (e.g., reverse genetics, enzyme assays, structures) and methodologies (statistics, epidemiology, health economics) will be available and shared for facilitating research protocols in the different Work Packages under agreed conditions that take into account the Nagoya Protocol, and research ethics in line with the World Health Organization's policy of benefit sharing.
The research programme takes into account the fact that epidemics of the co‐circulating arboviruses complicate the situation in the region, and will pay close attention to the diagnosis of dengue and chikungunya (among other potentially confounding pathogens). Moreover, ZIKV prospective clinical research programmes all face the potential constraint that sites currently experiencing large ZIKV outbreaks may have a reduced number of incident cases available for inclusion at the time the ZIKAlliance research programme starts. We have addressed this challenging situation in the design of our research:
- Inclusion of patients before the start of the project. This will be made possible by the collaboration with currently active prospective clinical research cohorts (IDAMS: Brazil, Venezuela & El Salvador; but also Suriname and French territories) and by access to specific bridging funds provided by bioMérieux for Brazilian cohorts.
- Flexibility to follow the epidemiological spread. The consortium must be ready to follow the spread of the epidemic. This will be made possible by accessing new sites in Brazil, and a number of locations in South America through Consortium partners (IRD, Institut Pasteur, FIOCRUZ, EMC, in Bolivia, Peru, Uruguay, Argentina, Cuba, Colombia, Trinidad, Curacao etc..).
- Flexible budget pool. The consortium will set aside funds in a pool of patient costs to be provisioned at WP1 leader institution, UKL, but to be used in the disease endemic countries following the epidemiological spread.
- Anticipation of epidemic spread. Some sites have been selected in anticipation of epidemic spread during the course of the project (e.g., Sao Paulo region, Bolivia, Cuba). This will allow studying the viral, clinical and epidemiological characteristics of nascent epidemics and the potential impact of early response.
- Global harmonization of protocols. Harmonization of protocols (for pregnant women and natural history cohorts) has been ongoing between members of the ZIKAlliance consortium and international agencies/ stakeholders (WHO, CDC, Institut Pasteur, ISARIC, CONSISE), funding agencies (NIH) and currently active research programmes (IDAMS, PREPARE, EVAg, ISARIC). The benefit of this is that patients can be enrolled and studied outside of ZIKAlliance with compatible protocols, made publicly available and a pooled dataset may later be analyzed for the maximum benefit
Finally, it is important to note that around 1 million European citizens in American overseas territories live under the threat of Zika disease (nearly 2 million considering the risk of propagation in the Indian Ocean). The consortium will operate in European overseas territories to support ongoing research programmes and will also actively monitor the risk of importation into mainland Europe. Therefore, the overarching goal of implementing sustainable collaborative clinical and scientific networks to address future epidemic threats will benefit European citizens in overseas territories as well as in mainland Europe.