CEPI Centralized Laboratory for Measurement of Immune Responses Elicited by SARS-CoV-2 Vaccine Candidates

CEPI Centralized Laboratory for Measurement of Immune Responses Elicited by SARS-CoV-2 Vaccine Candidates

Friday, 24 April, 2020

Comparing immune responses against different vaccine candidates intended for the prevention of the novel virus responsible for Coronavirus Disease 2019 (COVID-19) - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - is challenging given the global complexity in the number of institutions now focusing on developing SARS-CoV-2 vaccines. Biological variation and technical differences (how and where specimens are collected, transported, stored, and analysed) impacts the quality and usefulness of the data produced and makes comparisons between measurements in individual laboratories difficult.

To help reduce some of this complexity, better compare the immunological profile of each vaccine candidate, and provide robust assays for regulatory purposes, CEPI is planning to measure the immune response elicited by different vaccine in preclinical studies as well as Phase I and II clinical studies in the same (centralized) laboratory, establishing a common protocol or providing the data package which allows formal bridging to a common protocol and information sharing.

In preparation, CEPI has launched a Request for Proposals to identify and select potential partners. The types of studies that pre-approved providers might be asked to perform could include, but are not limited to:

  • ELISA assays
  • Wild type (BSL-3)
  • Pseudo-virus neutralisation assays (BSL-2)
  • T-cells ELISPOT assays

The call is open to any laboratory worldwide that are able to perform one or more vaccine-relevant immunological assays for SARS-CoV-2 for preclinical and/or human samples under GLP/GCLP conditions. Applicants must have the assay(s) proposed already in place and be willing to run comparability studies with other laboratories in different geographical regions or able to fast tech transfer the assay(s) from other laboratories. In addition, applicants must be able and willing to prioritise SARS-CoV-2 work over other ongoing projects when samples are ready for testing.

Framework agreements will be implemented with successful applicants to cover potential future provision of services. Laboratories that are awardees or sub-awardees in consortia with pre-existing grants from CEPI to conduct a defined scope of work will not have that work affected by the new framework agreements.

The deadline for applications is 10 May 2020 (15:00 CET).

 

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