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Immunomonitoring made simple

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Vaccine Applications Include

  • Antigen recall

  • Early safety studies

  • Profile the functional immune status of clinical trial participants

 

The use of TruCulture for vaccine development has been highlighted by two key examples:

 

  • 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. (2022) De Rosa SC, et al. Clinical & Translational Immunology. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8752373/

  • Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomized, placebo-controlled, phase 1-2, dose-ranging study. (2021) Goepfert PA, et al. Lancet Infectious Disease. https://doi.org/10.1016/S1473-3099(21)00147-X

 

Supplementary Material including TruCulture details and figures, view here.

 

For the two-dose cohort, pre-vaccination and post-vaccination blood samples (D1, D22, D36) were collected into three types of TruCulture tubes:

 

  1. Recombinant SARS-CoV-2 spike protein

  2. Negative control (TruCulture media only)

  3. Positive control (SEB + CD28)

 

Cytokines from supernatants were measured at Rules-Based Medicine. Production of Th1 associated cytokines (IFNg, IL-2 and TNFa) were elevated compared to Th2 associated cytokines (IL-4, IL-5, IL-13) on D22 and D36 whereas neutralizing antibodies were not significantly detected until D36. The AS03 adjuvant formulation generated stronger humoral and cell mediated immunity signals relative to the AF03 adjuvant. This study illustrates that TruCulture can be a vital tool for vaccine clinical trials to profile antigen specific T cell responses.

 

2. Flu Antigen Recall Responses using TruCulture with OptiMAP and SIMOA Analysis(2019) Hwang SA, et al.

The recall response of flu hemagglutinin (HA) antigens was examined in healthy adults vaccinated with the 2018-2019 annual flu vaccine. The TruCulture tubes used were:

 

  1. Null (TruCulture media only)

  2. Staphylococcal enterotoxin B (SEB)

  3. Null tubes spiked with 1.25mg each of 4 different recombinant HA proteins.

 

All samples were incubated for 48 hours at 37oC. Supernatant were collected and analyzed using the OptiMAP panel. No inflammatory cytokines were detected in the null tubes from either the baseline or 2 weeks post-vaccination samples. There were no differences in cytokine production in the SEB stimulated samples between the baseline and 2 weeks post-flu vaccination timelines. For flu HA stimulated samples, there was a significant increase in production of GM-CSF, IFN-­, IL-1‑, IL-6, IL-12p70, IL-23, and TNF-a at 2 weeks post-flu vaccination compared to samples collected at baseline. Additionally, flu HA stimulated samples post vaccination also demonstrated increased production of type I inteferons, as analyzed by SIMOA. These data demonstrate that TruCulture in conjunction with OptiMAP and SIMOA are useful tools for investigating antigen specific responses.