ArticleClinical & translational immunology2022
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.
Article in Clinical & translational immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04537208 (Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations), which is not on this map. Cited by 16 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older
Who cites it
16 citing papers in PubMed, 25 citations in OpenAlex.
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- Comparative molecular, innate, and adaptive impacts of chemically diverse STING agonists.Vaccine · 2025Review
- Prior human endemic coronavirus exposure does not affect humoral responses to SARS-CoV-2 protein vaccines.NPJ vaccines · 2025Article
- Construction and Immune Strategy Optimization of a Vaccine Strain for Influenza A (H5N8) Subtype.Viruses · 2025Article
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- The contributions of T cell-mediated immunity to protection from vaccine-preventable diseases: A primer.Human vaccines & immunotherapeutics · 2024Review
- Beta-variant recombinant booster vaccine elicits broad cross-reactive neutralization of SARS-CoV-2 including Omicron variants.Heliyon · 2024Article
- Non-Invasive Vaccines: Challenges in Formulation and Vaccine Adjuvants.Pharmaceutics · 2023Review
- A first-in-human germline-targeting HIV nanoparticle vaccine induced broad and publicly targeted helper T cell responses.Science translational medicine · 2023Article
- The Immune Response to SARS-CoV-2 Vaccine in a Cohort of Family Pediatricians from Southern Italy.Cells · 2023Article
- Integrated antibody and cellular immunity monitoring are required for assessment of the long term protection that will be essential for effective next generation vaccine development.Frontiers in immunology · 2023Review
- SARS-CoV-2 sublingual vaccine with RBD antigen and poly(I:C) adjuvant: Preclinical study in cynomolgus macaques.Biology methods & protocols · 2023Article
- Immunocytometric analysis of patients with thymic epithelial tumors revealed that COVID-19 vaccine booster strongly enhanced the immune response.Frontiers in immunology · 2023Article
- Host genetics impact on SARS-CoV-2 vaccine-induced immunoglobulin levels and dynamics: The role ofFrontiers in genetics · 2022Article
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Authors and funding
14 authors at 5 institutions in 3 countries.
Funding
Abstract
objectivesWe 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).
methodsA 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
resultsBoth 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
conclusionsThe whole-blood cytokine secretion assay is a high-throughput alternative for assessing the quantity and character of vaccine-induced cellular responses.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.