SIAT^® Immunogenicity Analysis Service for Vaccine

Overview Platform Advantages FAQ Resources

Immunogenicity is the ability of an antigen to cause the humoral or cell-mediated immune response in humans or other animals. The vaccine is a type of biological preparation that can produce active acquired immunity to a particular disease. A vaccine could be made of monoclonal antibodies (mAbs), proteins, peptides, PEGylated proteins, all of which are likely to be antigenic and greatly impacts the design of biomedical products. As a well-known expert in immunologic analysis, Creative Biolabs has abundant resources to develop advanced platforms to study the immunogenicity of clinical samples from vaccine studies. Particularly, we offer a wide range of techniques and validated methods for vaccine immunogenicity analysis in preclinical and clinical stages.

Overview

A key aspect of developing a new biologic, like a vaccine, is precisely assessing whether or not it is immunogenic or is able to cause an immune response. Immunogenicity is a property that can either be a desirable trait, for example in the generation of a robust protective immunity against certain pathogens, or an undesirable trait, for example when it relates to therapeutic candidates, where the immunity needs to be prevented.

The vaccine is typically associated with desirable immunogenicity, which is being at the center of vaccine efficacy. The injection of an antigen (from vaccines) can provoke an immune response directed the pathogen (e.g. virus, bacteria) aiming at protecting the organism. Vaccine immunogenicity and response are determined by factors and characteristics of both vaccine and host, including self-proteins, dose schedule, presence of adjuvants, route and site of administration, and vaccine handling.

SIAT® Immunogenicity Analysis Platforms at Creative Biolabs

Vaccine immunogenicity assays are required to measure immune responses and identify correlates of protection. The potential adverse response due to immunogenicity makes it a critical part of vaccine development and functional evaluation. At Creative Biolabs, our group has extensive experience in the development and validation of a series of analytical assays that are implemented in different stages of vaccine development. Remarkably, we have established the proprietary Sensitive Immunogenicity Assessment Technology® (SIAT®) system to study the immunogenicity for a variety of biological products or therapeutic treatments. Our quality efficacy and safety vaccine testing services including but not limited to:

Enzyme-linked immunosorbent assay (ELISA)/Radioimmunoassay (RIA) - High sensitivity and specificity ELISA/RIA method can be used to test vaccine immunogenicity. Our ELISA is split into two types, solid-phase ELISA and solution ELISA, and RIA is classified into formats, antigen-binding assay (ABA) and two-site assay.
Surface plasmon resonance (SPR) - It is an optical biosensing technology that has been used to detect protein interactions, by immobilizing the ligand on a thin metal film and measuring the shift in refractive index on the binding of analytes. The tool is applied in the vaccine area because of its real-time, label-free, and noninvasive nature.
MSD-ECL assays - The test consists of mesoscale discovery (MSD) and electrochemiluminescence (ECL) technology. This unique detection combines MSD platform with specialized tags which emit light by electrochemical stimulation. The intensity of light is captured by a charge-coupled device (CCD) camera and pixel intensity quantified. The system is the basis of achieving measurement of a log range of protein expression levels in different matrices.
Lanthanide Fluorescence Immunoassay (LFI) - It makes use of a dissociation enhanced lanthanide fluorescence for the detection of anti-drug antibodies in samples. This technique is an upgrade version of traditional ELISA assays and doesn’t need an enzyme in operations.
In vitro cell-based NAb-assay - This cell-based assay is designed to detect the existence of neutralizing antibodies (NAb). If the biological activity of a biotherapeutic product is limited to protein-protein binding or ligand-receptor binding, an MSD-Nab assay can be coupled to identify the presence of neutralizing antibodies.
Reverse vaccinology (RV) - It is a multistep process that starts from the bioinformatic prediction of surface-expressed proteins, followed by their individual expression and evaluation of immunogenicity in a suitable vaccination model. The fulfillment of RV has driven the development of Bexsero, a vaccine composed of recombinant protein antigens and an outer membrane vesicle.
In silico screening - T cell epitope content, one of the factors that contribute to the risk of immunogenicity, can now be analyzed by immunoinformatic algorithms. The clinical immunogenicity of a novel vaccine can be measured relatively accurately using in silico tools. We have integrated in silico immunogenicity into the pre-clinical process of vaccine discovery and development.

Advantages

Advanced platforms for vaccine immunogenicity and efficacy studies
Full range of laboratory services to support vaccine trials
Project scope is fully defined and is reflected in our quotations
Accurate assessment results with reproducible protocols

Vaccine development is a complex multistep process and the concept of immunogenicity of an antigen is frequently encountered under this context. To test the efficacy and safety of a vaccine, evaluating the immunogenicity of a vaccine is necessary. As a reliable supplier in clinical vaccine development, Creative Biolabs always devotes to immunogenicity analysis of immune-related diseases. As immunoassays are constantly evolving, we provide clients custom services the level most suited to the clinical phase of vaccine immunogenicity analysis. For more information, please directly contact us or discuss with our experts today.

Other optional immunogenicity analysis services for immune-related diseases:

FAQ

What is immunogenicity analysis for vaccines?
Immunogenicity analysis for vaccines assesses the immune response generated by a vaccine against its target pathogen. It involves measuring specific antibodies and cellular immune responses to determine whether the vaccine can effectively induce immunity that protects against the disease.
Why is immunogenicity analysis critical for vaccine development?
Immunogenicity analysis provides essential data on the vaccine's ability to elicit protective immune responses. This analysis helps in optimizing vaccine formulations, determining dosing schedules, and ensuring that the vaccine meets safety and efficacy standards before it proceeds to larger clinical trials.
How do you measure immunogenicity in vaccines?
Immunogenicity in vaccines is typically measured using serological assays like enzyme-linked immunosorbent assay (ELISA) to detect antibodies, neutralization assays to assess the ability of these antibodies to inhibit virus replication, and cellular assays to evaluate T cell responses. These measurements help determine the qualitative and quantitative aspects of the immune response.
What are the key indicators of a successful vaccine immunogenicity?
Key indicators of successful vaccine immunogenicity include the generation of high titers of neutralizing antibodies, a robust T-cell response, and the establishment of memory immune cells. These indicators suggest that the vaccine can provide long-term protection against the disease.
Can immunogenicity analysis predict long-term vaccine effectiveness?
Immunogenicity analysis can provide indicators of long-term vaccine effectiveness, especially through the measurement of memory B and T cells. However, predicting long-term effectiveness also requires real-world efficacy data and continuous monitoring post-vaccination to understand the duration of protection.
What are the implications of low immunogenicity in vaccine trials?
Low immunogenicity in vaccine trials can indicate insufficient immune response, which may lead to poor protection against the disease. This may require reformulation of the vaccine, addition of adjuvants, or adjustments in the dosage and vaccination schedule to enhance immunogenicity.
What advancements are enhancing immunogenicity analysis for vaccines?
Recent advancements in immunogenicity analysis include the use of more sophisticated molecular and cellular techniques, such as flow cytometry and mass cytometry, which allow for detailed profiling of immune cell subsets. High-throughput and multiplex technologies also provide broader insights into immune responses, improving the predictive power of immunogenicity assessments.