The VHFC will provide characterised recombinant antigens for LASV to NIBSC for production of the antigen standard. By carrying out cross-reactivity studies, the consortium will also provide information to guide the Programme Advisory Committee (PAC) on important decisions around antigen selection necessary for designing of assays for vaccine response evaluation.
The VHFC also plans to collect convalescent serum samples from different geographical areas, representing different clades of the Lassa virus. These serum panels (High, Medium, Low and Negative sera) will help to establish and fine-tune assays for vaccine-response measurements.
Interim standards that can be used as for assay development and standardization will initially be produced to support vaccine developers in the short term. The antibody standard will then be developed into a WHO International Standard. This process will involve co-ordination of collaborative studies to assure the suitability of these reference materials in standardizing assays used for measuring immune responses to candidate vaccines against Lassa fever.
“One of the key roadblocks to standards development in the past has been the access to patient samples. By working with organisations like ISTH and BNITM we hope that we’ll be able to get the samples we need more quickly, which ultimately means we can make our standards available to developers as soon as possible.”
Dr Mark Page, principal scientist at NIBSC
Piloting a new approach
By coordinating the steps in the standards production process, this programme aims to pilot a novel approach to development of biological standards that will lay the foundations for future biological-standards projects addressing other key public health areas.
NIBSC principal scientist Dr Mark Page commented:
“One of the key roadblocks to standards development in the past has been the access to patient samples. By working with organisations like ISTH and BNITM we hope that we’ll be able to get the samples we need more quickly, which ultimately means we can make our standards available to developers as soon as possible.”
“We also want to use our experience to streamline the standardisation process. For example, we’re hoping to produce an Interim Standard, like we did with Ebola, so we can give developers the tools they need faster.”
“Building connections across the Lassa fever field is critical for the success of the programme. We’re excited to work with other expert partners as part of this committee, and vaccine developers, to ensure we can deliver high-quality Biostandards that meet developer’s needs and will accelerate research into LASV vaccine candidates.”
Dr. Johan Holst, Senior Scientist at CEPI, Oslo said:
“There is currently no approved vaccine that protects against Lassa virus—CEPI hopes to change that. By bringing partners together in this pro-active way we hope to solve some of the current challenges to standards development such as sourcing material and the co-ordination of collaborative studies.”
“We see the Lassa Biostandards programme as a first step towards a more harmonised approach to making well characterised standards available early on for use in vaccine development and clinical evaluation.”
[1] Centers for Disease Control and Prevention. 2019. Lassa Fever. [ONLINE] Available at: https://www.cdc.gov/vhf/lassa/index.html. [Accessed 15 April 2019].