Rationale
The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting different vaccine candidates targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Comparing immune responses against different vaccine candidates intended for the prevention of SARS-CoV-2 is challenging. Biological variation and technical differences (how and where specimens are collected, transported, stored, and analyzed) impacts the quality and usefulness of the data produced and makes comparisons between measurements in individual laboratories difficult. Moreover, due to the fact that SARS-CoV-2 vaccine candidates worldwide make use of different technology platforms (e.g. recombinant viral vectors, live attenuated vaccines, recombinant proteins and nucleic acids), the evaluation of the true potential for each of the vaccine formulations becomes very complex.

The Service
In order to reduce some of this complexity, better assess the immunological profile of each vaccine candidate, and provide robust assays for regulatory purposes, CEPI is funding the testing of the immune response elicited by different vaccine in preclinical studies and Phase I and IIa clinical studies using validated assays in the same Centralized Laboratory.  This service will be available from September 2020 for any vaccine developer working on a SARS-CoV-2 vaccine worldwide, regardless of whether your vaccine development program is funded by a CEPI contract.
All samples will be blinded and after sample testing the Laboratory will provide you with the raw data as well as an analytical report. CEPI will make no claim to the data ownership but would require the use for CEPI-internal purposes only.

Centralized Laboratory Network
The CEPI Centralized Laboratory Network currently includes 7 laboratories:
·        2 in North America
·        3 in Europe
·        2 in Asia
The 7 Laboratories have extensive track records, appropriate quality systems and project management capabilities. They will perform the assays listed below using harmonised protocols, reagents and data handling.

Available assays
Types of assays that the Centralized Laboratory will perform include the following:
·        ELISA assay
Coating antigens: stabilized pre fusion full S, RBD; (NP will be available but not prioritized)
Total IgG in serum
Antibody Standard (provided by NIBSC[AS1] )) used as control
·        Virus neutralization assays, based on wild-type virus (BSL-3) and pseudotyped virus (BSL-2)
·        T-cells ELISPOT assay
Peptide pool of the whole S protein
Cytokines: IFNy (Th1), IL-2 (Th1), IL-5 (Th2)

Costs
CEPI will fully fund the testing of the immune response elicited by different vaccine in preclinical studies and Phase I and IIa clinical studies for any vaccine developer working on a SARS-CoV-2 vaccine worldwide.
Sample shipment costs and documentation related to the shipment is the Vaccine Developer’s responsibility.

In order to monitor the interest for the CEPI Centralized Laboratory Network worldwide and adjust the testing capacity, we are requesting Vaccine Developers to please answer a short Survey. 

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* 1. Please, fill in here your name, email address and the name of your organization:

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* 2. At what stage of development is your SARS-CoV-2 vaccine candidate?

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* 3. Are you already working with any Lab for immunogenicity sample measurement for the above mentioned assays?

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* 4. Are you interested in sending samples to the CEPI Centralized Laboratory Network for analysis?

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* 5. Which Phase the samples you are planning to send belong to?

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* 6. How many samples are you planning to send? Please, specify for each Phase

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* 7. In which country are your samples located? Please, specify for each Phase

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* 8. Which assays are you interested in?

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* 9. When are you planning to be ready to ship the samples? Please, specify for each Phase

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* 10. CEPI will review the data generated from the analysis of your samples for internal purposes upon signature of a Memorandum of Agreement. Are you comfortable with that?

0 of 10 answered
 

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