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.
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
· 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-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.
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
· 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-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.
When you are ready to formally apply for sample testing, complete and submit the Sample Analysis Request Form (www.surveymonkey.com/r/8K2YWLC)