Many investigational therapies directly or indirectly affect the immune system. Whether the objective is immune activation, immune suppression, immune restoration, or immune reconstitution, sponsors are increasingly expected to demonstrate not only biological activity, but functional immune competence.
Traditional biomarkers such as lymphocyte counts, cytokine levels, immune phenotyping, and gene expression signatures provide important mechanistic insights. However, they do not necessarily answer a critical clinical question:
An approved seasonal influenza vaccine provides a safe, standardized, and widely accepted immune stimulus that can be incorporated into clinical studies with minimal operational burden. By collecting a small number of serum samples before and after vaccination, sponsors can generate valuable exploratory data on the functional status of the immune system.
Seasonal influenza vaccination is routinely administered to millions of individuals every year across a broad range of patient populations. As a result, it offers a real-world assessment of the immune system's ability to recognize an antigen and generate a protective antibody response.
When paired with established assays such as Hemagglutination Inhibition (HAI), influenza vaccination can provide evidence of:
Adding an influenza vaccine response assessment does not require a separate clinical study.
|
Pre-vaccination |
Vaccination |
Post-vaccination |
| Baseline serum sample | Administration of approved standard-of-care seasonal influenza vaccine | Serum collection approximately 21-28 days later |
| Baseline immune profiling (optional) | HAI and/or microneutralization testing | |
| Optional cellular immunology assessments |
The result is a low-burden exploratory endpoint capable of generating meaningful translational evidence from a limited number of additional samples.
Demonstrate recovery or restoration of immune function following chemotherapy, immune-modulating treatments, or novel oncology therapies.
Evaluate whether disease control is achieved while maintaining the ability to generate protective immune responses rather than inducing broad immunosuppression.
Provide functional evidence of immune reconstitution following conditioning regimens, stem cell transplantation, gene therapy, or cell-based therapies.
Generate interpretable functional immune biomarkers in studies where traditional efficacy endpoints may be limited or difficult to evaluate.
Influenza vaccine response assessments are not intended to replace efficacy endpoints.
Instead, they can provide supportive evidence regarding:
For therapies that affect the immune system, these data can help bridge the gap between mechanistic biomarkers and clinically meaningful immune performance.
hVIVO combines expertise in influenza, clinical research, immunology, and specialty laboratory testing to deliver integrated influenza vaccine response assessments within existing clinical development programs.
Our capabilities include:
The Opportunity
With only a standard influenza immunization and a small number of strategically timed serum samples, sponsors can gain valuable insight into whether their therapy leaves the immune system functional, responsive, and capable of mounting a protective immune response.
A simple addition to study design. A meaningful addition to the scientific story.
This article was written by hVIVO Associate Maria Menikou, reviewed by Dr Andrew Catchpole.