Developing a case definition for Aseptic Arthritis
The first reports of recombinant vesicular stomatitis virus (rVSV) Zaire ebolavirus (ZEBOV) Vaccine Phase 1 trials were published on April 2, 20151,2. In one trial 11 (22%) out of 51 previously healthy participants presented with arthralgia within 2 weeks following immunization. 9 of them were diagnosed to have (aseptic) arthritis. The WHO-GACVS is reviewing the evidence from the available trials.
Harmonisation of outcome definitions and minimal guidance for safety data collection, analysis, and publication will facilitate analysis and interpretation of the published data as well as future trials and observational studies during the life cycle of this and other candidate Ebola Vaccines.
The Brighton Collaboration is prepared to address this need in close collaboration with WHO and its partners. The Brighton Collaboration can leverage unique capacity for the achievement of these objectives. It will create an ad hoc Arthritis Working Group to develop a working definition by the end of June 2015. According to the standard process, a systematic literature review will be commissioned. Due to the urgent need for a working definition, this will be done with subject matter experts in parallel to definition development. The global consensus process following public consultation with the Brighton Collaboration Reference Group, will be after the submission of a working definition to the GACVS. The Brighton Collaboration Science Board, Clinical Advisory Forum of Experts, and the Reference Group will be engaged in a rapid turnaround approval process to rapidly achieve a working draft definition. Overall, the Brighton standard process will be tailored so that protocol development, data collection and preliminary data interpretation of Ebola vaccine safety data will be supported and availability of the final and standardized case definition will allow for updated and comparable data interpretation.