Development of an in vitro method to assess the immunogenicity of biologics in the prevention of infectious diseases.

Development of an in vitro method to assess the immunogenicity of biologics in the prevention of infectious diseases.

Publication date: Sep 03, 2025

We present a series of preclinical studies focused on developing in vitro 2D and 3D models for assessing immunogenic factors in preventing infectious diseases. Human peripheral blood mononuclear cells (PBMC) and Calu-3 cell lines (bronchial epithelial cells) were used to develop 2D and 3D models. Peptides: Spike-S1-His (S-His), nucleocapsid-His and adjuvants: human adenovirus five serotype-based viral vector (AdV-D24-ICOSL-CD40L), armed with inducible co-stimulator (ICOSL) and CD40 ligand (CD40L), and a vector lacking these transgenes (AdV5/3) were used due to their effective initial interaction with antigen-presenting cells (APC). Studying the potency of biologics in vitro revealed a significant increase in the percentage of CD4 TCM, CD4 TEMRA, and CD4 TEM lymphocyte subpopulations involved in memory cell generation after 24 h of treatment. Prolonging the exposure for 7 days, a significant increase in CD4 cells was observed when PBMCs were treated with AdV1 (56. 00 +/- 0. 26% vs. 48. 17 +/- 1. 10%). In contrast, a decrease in CD8 cells was observed in those treated with AdV1 (37. 93 +/- 0. 35%) compared to AdV1 + S-His + N-His (38. 47 +/- 0. 38%) versus the untreated group (44. 63 +/- 1. 07%). A decrease in EMRA was noted when PBMCs were treated with AdV1 + S-His + N-His (2. 97 +/- 0. 23% vs. 4. 50 +/- 0. 35%). Moreover, it was pointed out that PBMCs treated with AdV1 alone or in combination with S-His and N-His showed an elevated number of nacEFve CD4/CD8 and SCM CD4/CD8 cells. No changes in the number of EMRA CD4 subpopulations were detected when PBMCs were treated with AdV2 compared with untreated ones (4. 27 +/- 0. 06% vs. 4. 50 +/- 0. 35%). Analysis of the humoral response induced by AdV1, AdV2, S-His, N-His, AdV1 + S-His + N-His, and AdV2 + S-His + N-His showed that AdV1 alone (4. 17 +/- 0. 25% vs. 3. 17 +/- 0. 06%) and in combination with S-His and N-His (3. 87 +/- 0. 25 vs. 3. 17 +/- 0. 06%) slightly increased the number of CD19 cells. RNA-Seq analysis of PBMC cells in the 3D model revealed gene overexpression, including FGFR4, associated with the Rap1 pathway in samples exposed to AdV1 + S-His + N-His. Thus, the proposed platform’s impact on lymphocyte differentiation was confirmed, and cytokine profile analysis in this sample revealed elevated levels of IL-10, IL-12p70, and IL-8. All samples exposed to AdV showed increased levels of IFN-γ. The safety and biodistribution studies of the vaccine platform demonstrated that a 30-day exposure did not impact mice’s survival or organ morphology. Exploring the CD40 pathway notably reveals its significant impact on immune cell populations, suggesting potential therapeutic avenues.

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Concepts Keywords
7days 3D model
Biodistribution Biological Products
Cd40l Biological Products
Lymphocyte Calu-3
Viral CD4-Positive T-Lymphocytes
CD8-Positive T-Lymphocytes
Cell Line
Cytokines
Ex vivo
Humans
Immunogenicity
Immunology
Invivo
Leukocytes, Mononuclear
Lymphocytes
SARS-CoV-2
Vaccines

Semantics

Type Source Name
disease MESH infectious diseases
disease IDO blood
disease IDO cell
drug DRUGBANK Tretamine
drug DRUGBANK Spectinomycin
drug DRUGBANK Interleukin-10
drug DRUGBANK Aminosalicylic Acid
disease MESH viral infections
disease MESH emergency
drug DRUGBANK Trestolone
disease MESH blood clots
disease MESH COVID 19
pathway REACTOME Adaptive Immune System
disease MESH cytokine storm
pathway REACTOME Immune System
disease MESH infection
disease IDO immune response
pathway REACTOME Apoptosis
disease MESH Influenza
drug DRUGBANK Methylergometrine
drug DRUGBANK Streptomycin
disease MESH tumor
disease MESH mesothelioma
drug DRUGBANK Hepatitis B Vaccine (Recombinant)
drug DRUGBANK Dimethyl sulfoxide
disease MESH virus titer
disease IDO host
drug DRUGBANK Histidine
pathway KEGG Viral replication
drug DRUGBANK Sodium lauryl sulfate
disease IDO assay
disease IDO process
drug DRUGBANK Hyaluronic acid
disease MESH Delta Infection
drug DRUGBANK Trimebutine
disease IDO intervention
disease MESH necrosis

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