caret

CEPI Networks: Centralised Labs and Preclinical Models

CEPI has set up two networks for researchers to assess their vaccine candidates under development:

  1. Centralised Labs Network
  2. Preclinical Models Network

 

Centralised Labs Network

Comparing immune responses against different COVID-19 vaccine candidates is challenging. To provide a more uniform evaluation of COVID-19 vaccine candidates in preclinical and clinical testing (up to Phase II), CEPI established a Centralised Labs Network, located across multiple regions globally, using the same testing reagents and following common protocols to measure the immunogenicity of multiple COVID-19 vaccine candidates.

The network is open for use to all COVID-19 vaccine developers (both CEPI-supported and non-CEPI-funded vaccine developers).

In order to monitor interest and adjust the testing capacity, we are requesting that all COVID-19 vaccine developers interested in using CEPI’s centralised laboratory network, please complete this short survey.

For any COVID-19 vaccine developer ready to submit their samples to the network, please complete this form.

 

Preclinical models network

CEPI has established a network of high-containment laboratories (BSL-3 and -4) for testing of vaccines against our priority pathogens in preclinical models.

Our laboratory partners have been selected based on their scientific excellence, their robust quality systems, and their strong ethical practices. To date, we have established partnership agreements with UK Health Security Agency, NIBSC, Wageningen Bioveterinary Research (WBVR), University of Pittsburgh, Boston University National Emerging Infectious Diseases Laboratories (NEIDL), and CSIRO, and have a number of other partnerships under negotiation.

CEPI commissions the laboratories to establish preclinical models of infection/disease. These preclinical models are made available to CEPI-supported vaccine developers to test their vaccine candidates. This will allow vaccine developers to have their candidates rapidly assessed. It also allows CEPI and potential future vaccine regulators to be sure that the vaccine has been assessed in its early stages under rigorous quality standards.

The majority of the work in this area has focused on preclinical models for COVID-19, but we have also commissioned work on Nipah, Lassa fever, and Chikungunya, and will look to start work on MERS, and Rift Valley fever preclinical models in the near future.

Find out more

Researcher preparing a DNA analyser. Image credit: James Gathany

Collecting vaccine pipeline data

Vaccines can be powerful tools for preventing outbreaks of infectious diseases becoming humanitarian crises. However, developing these vaccines requires significant investment and evidence on what it would cost to successfully develop an effective vaccine against such diseases are scarce.

We assessed 224 vaccine candidates from preclinical through to phase 2 for 11 priority epidemic infectious diseases. Our study showed that the cost of progressing at least one vaccine through to the end of phase 2a for each of the 11 diseases would cost a minimum of $2.8-$3.7 billion ($1·2 billion–$8·4 billion range). By comparison, the global cost of a moderately severe to severe pandemic is thought to be as much as $570 billion.

You can read the full research paper in The Lancet Global Health.

224

Number of vaccine candidates against 11 priority epidemic infectious diseases identified through CEPI research.

$2.8 billion

The minimum average cost for progressing one vaccine against each of WHO’s 11 priority epidemic infectious diseases

$570 billion

The estimated annual global cost of moderately severe to severe pandemics

We are continuing to map available vaccine candidates against emerging infectious disease and their associated costs, concentrating on the vaccine research and development pipelines for diseases listed in the World Health Organisation’s R+D Blueprint (ie, Crimean Congo haemorrhagic fever, Lassa fever, MERS-CoV, Severe Acute Respiratory syndrome, Nipah, Rift Valley Fever,  Zika, Ebola and Marburg).

We are also mapping vaccine candidates for other diseases that have epidemic potential not included in the R+D Blueprint priority list, including Chikungunya and Severe Fever with Thrombocytopaenia Syndrome.

If you are working within this space and would like to contribute information about your vaccine candidate against epidemic disease threats, please email us [email protected].

Researching emerging infectious diseases

LassaEbola
Lassa
Ebola

Lassa

We currently have six Lassa vaccine candidates within our portfolio. While all candidates are currently in preclinical phase or Phase 1 studies, clinical trials in countries with outbreaks of Lassa could start over the next few years.

In order to run these clinical trials, epidemiological data is essential, however the data currently available is not sufficient. We will be funding epidemiological studies of Lassa fever in West Africa to inform future trial design, endpoints and site selection for Lassa vaccine development.

Research groups interested in performing such studies initially expressed their interest through an online application form. Some of those applicants were then selected for prequalification and invited to apply for funding through a formal request for proposals launched at the end of 2018. In order to determine how these epidemiological studies should be conducted, prequalified applicants were invited to a Lassa workshop in November 2018 to discuss the core protocol needed for these studies.

Ebola

In addition to conducting research to support our priority diseases, we are also working on improving the understanding into other diseases with epidemic potential, such as Ebola.

At the time of the 2014-15 Ebola outbreak in West Africa, a handful of vaccine candidates were in the pipeline, and while data on safety and effectiveness of the Merck VSV vaccine was gained from clinical trials conducted in 2015 and 2016, no vaccine has yet been licensed.

Because the human response to vaccines is different than the response to natural infection, and the non-human primate model does not mirror the human response, we are working to further support the scientific underpinning of Ebola vaccine development by helping animal model developers, vaccine developers, and regulators better understand and collate what is known about the human immune response.

In October 2018, we issued a request for proposals for the compilation of Ebola survivor data and literature.

We aim to produce a succinct and easily accessible summary, along with presentation of underlying data, to contribute to our understanding of the human immune response to Ebola virus infection and vaccination with Ebola vaccine candidates. We also will use this data to develop additional animal models that could be used by regulators to assess the likely safety and immunogenicity of vaccine candidates.

©2023 CEPI. All rights reserved