WHO
© Credits

Accelerating the licensure of Lassa vaccines: Generating robust evidence on vaccine efficacy and safety

25 – 26 October 2022

Date: Tuesday 25 October, 2022 & Wednesday 26 October, 2022

 

Location: Abuja, Nigeria

Hybrid Meeting: In-person & Online

The WHO R&D Blueprint Team and Coalition for Epidemic Preparedness Innovations (CEPI) together with the co-hosting partner organisations Nigeria Centre of Disease Control (NCDC) and Africa Centres for Disease Control and Prevention (ACDC), are organising a workshop on "Accelerating the licensure of Lassa vaccines Generating robust evidence on vaccine efficacy and safety".

The workshop will bring together Lassa fever disease experts, epidemiologists, clinical researchers, public health and regulatory authorities, vaccine developers as well as many other experts in the field.

The objectives of the workshop are:

  • To discuss Lassa virus disease, epidemiology and immunology.
  • To present current vaccine candidates under development.
  • To outline the design options for clinical efficacy trials for Lassa vaccines.
  • To develop a collaborative approach with key stakeholders to advance Lassa vaccine development and evaluation.

Presentations will be available

PRESENTATIONS

Objectives of meeting

Session 1: Lassa fever disease, epidemiology, and immunology 

Clinical Features of Lassa Fever in Nigeria  

Clinical management of Lassa fever Disease 

A Brief overview of Lassa fever epidemiology and current surveillance systems - LIBERIA

Overview of Lassa fever epidemiology and current surveillance systems in Guinea

Overview of Lassa fever epidemiology and current surveillance systems in Nigeria

Overview of Lassa Fever Epidemiology and Surveillance System in Sierra Leone

Preliminary data from ENABLE: A multi-country Lassa fever epidemiology study

Review of Lassa fever host immune response and protective immunityReview of Lassa fever host immune response and protective immunity

Session 2: Overview Lassa fever vaccine development programs 

A global TPP: What do we want to achieve with a Lassa vaccine? 

PADOVAX- Lassa Overview

IAVI VSV Lassa Fever Vaccine Candidate Development Overview

CEPI-WHO LASSA Workshop INO-4500 and CELLECTRA 2000

EBS-LASV, a dual-attenuated rVSV-vectored vaccine candidate for Lassa fever

Potential regulatory pathways towards vaccine licensure

Session 3: Designing Phase 3 efficacy trials for Lassa fever vaccines 

Efficacy trials of Lassa Vaccines: endpoints, trial design, site selection (Objectives, endpoints and success criteria, trial populations)

Considerations on case definitions and potential secondary / exploratory objectives & endpoints 

Statistical considerations: Trial design and sample size

Some examples of statistical issues in the efficacy trial

Considerations for Vaccine Safety Assessment​

Experiences in multi-country trials and platform trial approaches

Ebola Virus Disease in Liberia: Strategic Approach to EVD Vaccine Trials

Multinational cooperation for vaccine development

Multi-national consortiums to coordinate and facilitate vaccine(s) evaluation –Experience with the Meningitis Vaccine Project

Session 4: Working group sessions 

Proposed trial design and implementation and Regulatory and policy considerations

Collaborative approach to evaluate Lassa fever vaccines

Session 5: Ways forward and opportunities for collaboration

Community engagement and good participatory practices: lessons learned and existing tools

A transparent framework for selecting vaccines to be evaluated in Phase 2b/Phase 3 trials – experience from COVID vaccines 

The role of a single DSMB and the outline of the governance framework for the trials 

Accelerating the licensure of Lassa vaccines Generating robust evidence on vaccine efficacy and safety

CEPI Equitable Access Provisions

Présentation de la fièvre de Lassa, Guinée

Session 6: Other enabling activities 

Effectiveness of Ribavirin for Lassa Fever: Systematic Review 

Towards use of standardized assays: the role of a central lab 

Diagnostics: performance evaluation and access 

Other Lassa fever research priorities relevant for vaccine evaluation

 

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