Preparing for Lassa vaccine clinical trials with targeted epidemiology studies

8th and 9th November 2018
Noguchi Memorial Institute for Medical Research, Accra, Ghana

Introduction

Given the current development of multiple vaccine candidates against Lassa Fever Virus (LASV), some of which will begin testing in phase I clinical trials at the beginning of 2019, the Coalition for Epidemic Preparedness Innovations (CEPI) organized a workshop on the “Preparing for Lassa vaccine clinical trials with targeted epidemiology studies”,
with the objectives to:

1. Identify data needs, objectives, case definition, study designs, laboratory confirmation and key harmonized elements of CEPI funded studies to facilitate vaccine development for Lassa
2. Discuss options for enhanced collaboration and set up of governance of the targeted epidemiology studies to be funded by CEPI

and to answer key questions:

1. What epidemiological research programs are needed in advance of potential phase I, II and III clinical trials in the next Lassa seasons?
2. What data is essential, and what should be standardized between studies?
3. What work is already underway, and what research gaps currently exist?
4. How can Lassa Fever (LF) research groups most effectively collaborate to address the unmet research needs on epidemiology data to facilitate future field evaluation of Lassa vaccines?

The essential question of the workshop was to discuss the ways to define areas where the incidence of symptomatic cases will be high enough to conduct a vaccine efficacy trial. The experts invited to the workshop were those shortlisted (7 of 10 received submissions) from the Lassa epidemiology Expression of Interest, LF subject matter experts and representatives from Ministries of Health (MoH) in affected countries (Nigeria, Guinea, Sierra Leone, Liberia and Benin), World Health Organization (WHO), Africa Center for Disease Control (CDC), non-governmental organizations (NGOs), academic institutions and groups working in collecting Lassa data, and individuals selected with specific expertise. All attendees provided insights to harmonize protocol elements for targeted epidemiology studies. The agenda of the meeting can be found in Annex 1. This report provides a brief overview of the presentations made at the workshop as well as the outcome of the breakout sessions and the ensuing plenary discussions.