4th WHO R&D Blueprint Consultation on Vaccine evaluation in Public Health Emergencies

30 – 31 October 2017
On 30-31 October 2017, WHO convened about 30 experts in clinical trials, epidemiology, regulatory and infectious disease modelling to attend a 4th R&D Blueprint consultation on vaccine evaluation in Public Health Emergencies (PHEs). Since the first meeting in March 2016, the group has been working on a collaborative research preparedness workplan to improve the way we design, conduct and analyze vaccine efficacy studies in PHEs. The Blueprint priority pathogens were used to frame the conversation and illustrate the group’s thinking and rationale based on lessons learned from past and current outbreaks. Working groups are developing : (i) a comprehensive methodological discussion paper on vaccine study designs; (ii) a decision tree to guide methodology experts during the design of a vaccine trial and promote discussion around key methodological choices; (iii) a simulator using realistic outbreak scenarios to assess trials feasibility and; (iv) generic annotated protocols for various study designs.Summary of activities by Working Groups. The Boston meeting provided the opportunity to all groups to review all materials and tools being developed by each group, before WHO submits those for online public consultation in Q1 2018. In addition, a series of 4 manuscripts have been drafted, reflecting on each group’s work, and will be submitted to a peer-reviewed journal in January 2018.

Tools developed by the working group for vaccine evaluation

Tool #1

Under the Research & Development (R&D) Blueprint Plan of Action, the World Health Organization (WHO) has convened a group of experts in clinical trials, regulatory, and outbreak management, to agree on standard procedures to rapidly evaluate experimental vaccines during public health emergencies (PHEs) while maintaining the highest scientific and ethical standards. This guidance document details major vaccine study designs that could be used during outbreaks and PHEs of emerging and re-emerging pathogens for which there is no licensed vaccine.

This guidance outlines generic principles and methodological elements on how to best design, implement and analyse vaccine trials during PHEs. For each priority pathogen, WHO will convene experts to apply and tailor the proposed methodology to generate a pathogen-specific vaccine evaluation guidance. Advance planning for vaccine trial designs is critical for rapid and effective response to a PHE and to advance knowledge to address and mitigate future PHEs.

The current DRAFT guidance document “Design of Vaccine efficacy Trials to be used during public health emergencies “ is now posted for global online consultation. Please provide your edits/comments to the document and share your inputs to gsellp@who.int by COB August 31st.

Tool #2

As part of the working group, an interactive tool was developed to help diverse stakeholders design a vaccine efficacy trial and navigate the various options presented in the generic guidance document.

The InterVax Tool is an online visual, interactive tool developed to help diverse stakeholders navigate the various epidemiological, logistical and ethical decisions involved in the design of a vaccine efficacy trial during emerging epidemics.

The tool is not intended to provide a black box decision tree for identifying an optimal trial design, but rather a means of facilitating a transparent, collaborative and comprehensive discussion of the relevant decisions and for recording the decision process.