Whole‐blood cytokine secretion assay as a high‐throughput alternative for assessing the cell‐mediated immunity profile after two doses of an adjuvanted SARS‐CoV‐2 recombinant protein vaccine candidate

Author:

De Rosa Stephen C1,Cohen Kristen W1,Bonaparte Matthew2,Fu Bo3,Garg Sanjay4,Gerard Catherine5,Goepfert Paul A6,Huang Ying1,Larocque Daniel7,McElrath M. Juliana1,Morris Daryl1,Van der Most Robbert8,Bruyn Guy9,Pagnon Anke7ORCID

Affiliation:

1. Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA

2. Global Clinical Immunology Sanofi Pasteur Swiftwater PA USA

3. Biostatics Sanofi Pasteur Swiftwater PA USA

4. R&D Operations Sanofi Pasteur Swiftwater PA USA

5. R&D GlaxoSmithKline Vaccines Rixensart Belgium

6. Department of Medicine University of Alabama at Birmingham Birmingham AL USA

7. Research Department Sanofi Pasteur Marcy l’Étoile France

8. Translational Science GlaxoSmithKline Vaccines Rixensart Belgium

9. Global Clinical Development Sanofi Pasteur Swiftwater PA USA

Publisher

Wiley

Subject

General Nursing,Immunology,Immunology and Allergy

Reference48 articles.

1. Regulatory Affairs Professionals Society (RAPS).COVID‐19 vaccine tracker.2021. Available athttps://www.raps.org/news‐and‐articles/news‐articles/2020/3/covid‐19‐vaccine‐tracker. Accessed on 27 April 2021.

2. Gavi The Vaccine Alliance.Four reasons why we need multiple vaccines for Covid‐19. Available athttps://www.gavi.org/vaccineswork/four‐reasons‐why‐we‐need‐multiple‐vaccines‐covid‐19. Accessed 06 July 2021.

3. European Medicines Agency.Committee on human medicinal products: Guideline on clinical evaluation of vaccines (draft).2018. Available athttps://www.ema.europa.eu/en/documents/scientific‐guideline/draft‐guideline‐clinical‐evaluation‐vaccines‐revision‐1_en.pdf. Accessed 19 July 2021.

4. World Health Organization.Guidelines on clinical evaluation of vaccines: regulatory expectations: Revision of WHO TRS 924 Annex 1.2016. Available athttps://www.who.int/biologicals/expert_committee/Clinical_changes_IK_final.pdf. Accessed 19 July 2021.

5. Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus

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