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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.
De Rosa, Stephen C; Cohen, Kristen W; Bonaparte, Matthew; Fu, Bo; Garg, Sanjay; Gerard, Catherine; Goepfert, Paul A; Huang, Ying; Larocque, Daniel; McElrath, M Juliana; Morris, Daryl; Van der Most, Robbert; de Bruyn, Guy; Pagnon, Anke.
  • De Rosa SC; Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA.
  • Cohen KW; Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA.
  • Bonaparte M; Global Clinical Immunology Sanofi Pasteur Swiftwater PA USA.
  • Fu B; Biostatics Sanofi Pasteur Swiftwater PA USA.
  • Garg S; R&D Operations Sanofi Pasteur Swiftwater PA USA.
  • Gerard C; R&D GlaxoSmithKline Vaccines Rixensart Belgium.
  • Goepfert PA; Department of Medicine University of Alabama at Birmingham Birmingham AL USA.
  • Huang Y; Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA.
  • Larocque D; Research Department Sanofi Pasteur Marcy l'Étoile France.
  • McElrath MJ; Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA.
  • Morris D; Vaccine and Infectious Disease Division Fred Hutchinson Cancer Research Center Seattle WA USA.
  • Van der Most R; Translational Science GlaxoSmithKline Vaccines Rixensart Belgium.
  • de Bruyn G; Global Clinical Development Sanofi Pasteur Swiftwater PA USA.
  • Pagnon A; Research Department Sanofi Pasteur Marcy l'Étoile France.
Clin Transl Immunology ; 11(1): e1360, 2022.
Article in English | MEDLINE | ID: covidwho-1619419
ABSTRACT

OBJECTIVES:

We previously described the Phase I-II evaluation of SARS-CoV-2 recombinant protein candidate vaccine, CoV2-PreS-dTM, with AF03- or AS03-adjuvant systems (ClinicalTrials.gov, NCT04537208). Here, we further characterise the cellular immunogenicity profile of this vaccine candidate using a whole-blood secretion assay in parallel to intracellular cytokine staining (ICS) of cryopreserved peripheral blood mononuclear cells (PBMCs).

METHODS:

A randomly allocated subset of 90 healthy, SARS-CoV-2-seronegative adults aged ≥ 18 years who had received (random allocation) one or two separate injections (on study day [D]1 and D22) of saline placebo or CoV2-PreS-dTM formulated with AS03 or AF03 were included. Cytokine secretion was assessed using a TruCulture® whole-blood stimulation system in combination with multiplex bead array, and intracellular cytokine profiles were evaluated on thawed PBMCs following ex vivo stimulation with recombinant S protein at pre-vaccination (D1), post-dose 1 (D22) and post-dose 2 (D36).

RESULTS:

Both methods detected similar vaccine-induced responses after the first and second doses. We observed a Th1 bias (Th1/Th2 ratio > 1.0) for most treatment groups when analysed in whole blood, mainly characterised by increased IFN-γ, IL-2 and TNF-α secretion. Among participants aged ≥ 50 years, the Th1/Th2 ratio was higher for those who received vaccine candidate with AS03 versus AF03 adjuvant. ICS revealed that this higher Th1/Th2 ratio resulted from higher levels of IFN-γ expression and that the vaccine induced polyfunctional CD4+ T cells.

CONCLUSIONS:

The whole-blood cytokine secretion assay is a high-throughput alternative for assessing the quantity and character of vaccine-induced cellular responses.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Clin Transl Immunology Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Clin Transl Immunology Year: 2022 Document Type: Article