Beyond Influenza: Measuring Immune Function in Trials

Move Beyond Measuring Immune Cells. Measure Immune Function

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:

Can the patient still mount an effective immune response?

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. 

Why Influenza Vaccination?

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:

• • Immune competence
  • Immune restoration
  • Preservation of protective immunity
  • Immune reconstitution
  • Pharmacodynamic activity
  • Biological effect of immune-modulating therapies

Simple to Integrate into Existing Clinical Trials

Adding an influenza vaccine response assessment does not require a separate clinical study.

The result is a low-burden exploratory endpoint capable of generating meaningful translational evidence from a limited number of additional samples.

Applications Across Immune-Modulating Therapeutic Areas

Oncology

Demonstrate recovery or restoration of immune function following chemotherapy, immune-modulating treatments, or novel oncology therapies.

Autoimmune and Rheumatology

Evaluate whether disease control is achieved while maintaining the ability to generate protective immune responses rather than inducing broad immunosuppression.

Cell and Gene Therapy

Provide functional evidence of immune reconstitution following conditioning regimens, stem cell transplantation, gene therapy, or cell-based therapies.

Rare Diseases

Generate interpretable functional immune biomarkers in studies where traditional efficacy endpoints may be limited or difficult to evaluate.

Additional Evidence for Development and Regulatory Discussions

Influenza vaccine response assessments are not intended to replace efficacy endpoints.

Instead, they can provide supportive evidence regarding:

• Functional immune status
• Mechanism of action
• Target engagement
• Dose selection
• Infection risk assessment
• Long-term immune competence
• Benefit-risk characterization

For therapies that affect the immune system, these data can help bridge the gap between mechanistic biomarkers and clinically meaningful immune performance.

How hVIVO Can Help

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:

• HAI assays
• Microneutralisation assays
• Serological testing
• B-cell and T-cell immunophenotyping
• Cytokine profiling
• Translational immunology support

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.

Talk to our team.

This article was written by hVIVO Associate Maria Menikou, reviewed by Dr Andrew Catchpole.