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hVIVO Laboratory Services for Human Challenge Studies

Human Challenge Study Laboratory Services
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hVIVO - Lab Work
hVIVO provides specialised laboratory services that underpin the scientific rigor, safety, and reliability of human challenge studies. Our integrated labs deliver high‑quality virology, immunology, molecular and bacteria data to accelerate vaccine and therapeutic development.

25+

years experience in challenge agent development and clinical virology

GLP/GCP‑aligned labs with validated assays across respiratory & infectious diseases

Rapid, high‑quality data turnaround, enabling faster decision‑making

Industry‑leading immunology & virology expertise supporting Phase I-III trials

GCLP and ISO 17025-2017 certified

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Start‑ups & Early‑stage Biotechs

Access high‑quality immunology & virology capabilities, accelerate decision‑making. 

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Emerging & Mid‑size Biotechs

Support IND/CTA filings with robust assay packages and validated data.
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Large Pharma

Scalable disease‑specific lab infrastructure ensuring consistency across challenge studies.
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The Service

End‑to‑end scientific and analytical support for human challenge trials, including challenge agent characterisation, sample testing, exploratory biomarkers, virology, immunology, molecular analysis, and bioanalysis.

The Process

  1. Assay Design & Feasibility – Identify the most appropriate assays and biomarkers for your model.

  2. Validation & Optimisation – Validate or transfer assays to meet regulatory and model‑specific requirements.

  3. Sample Collection & Processing – Integrated clinic‑to‑lab workflows ensure high integrity.

  4. Testing & Data Generation – Virology, immunology, and molecular assays conducted under GLP/GCP alignment.

  5. Data Reporting & Interpretation – High‑resolution datasets with expert interpretation. 

hVIVO Capabilities

Virology

  •  qPCR

  • Viral load

  • Viral kinetics

  • Infectivity assays

  • Viral culture

Immunology

  • ELISA

  • ELISpot

  • Flow cytometry

  • Serology

  • Cytokine multiplex

Molecular

  • PCR panels

  • Sequencing

  • Gene expression analysis

  • NGS and bioinformatics

  • Rapid PCR qualification of respiratory infections, through single and multiple target quantification at scale using RT-qPCR and ddPCR platforms underpinned by Hamilton automated platforms

  • Genotyping and variant analysis utilising NGS in accordance with FDA guidance. 

Bioanalytical

  • PK/PD assays

  • Host immune response markers 

Why hVIVO?

  • Purpose‑built labs for controlled infection models with disease‑specific assays
  • Integrated clinical and lab workflows ensure speed and accuracy
  • Experts in respiratory and infectious diseases across influenza, RSV, HRV, hMPV, SARS‑CoV‑2, malaria, and more
  • Regulatory‑aligned workflows designed for IND/CTA support
  • Large BSL-2 and BSL-3 facilities
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Related Resources

Explore our blogs and resources on Virus & Bacteria Production & Characterisation for Human Challenge Trials, covering GMP manufacturing and scientific characterisation approaches used to develop safe, infectious challenge agents for high-fidelity clinical studies.
View all
Blog Human challenge trials Infectious diseases

From RSV to hMPV: Building the Next Generation of Respiratory Challenge Models

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 7 min read
Blog Laboratory Human challenge trials

Controlled Human Infection Model's (CHIM) in your backpack: how Human Challenge Trials support regulatory approval of travel vaccines

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 5 min read
Blog Human challenge trials Trial design

Unravelling the hMPV Surge: From Media Attention to Vaccine Development

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 6 min read
Blog Human challenge trials Respiratory viruses

Why are Biotech’s & Pharma Using Human Challenge Studies for Drug Development?

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 4 min read
Blog Human challenge trials Infectious diseases

Tripledemic Takedown: How Human Challenge Trials are Ideal to Expedite Multivalent Vaccine Development

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 9 min read
Blog Laboratory Human challenge trials

Empowering Next‑Gen Infectious Disease & Vaccine Development

Elisa Masat
Elisa Masat
10 Apr 2026 3 min read
Blog Human challenge trials Trial design

Human Challenge Studies: Their Conduct and Safety Aspects

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 9 min read
Blog Human challenge trials Phase II

Human Challenge Trials as a tool in raising funding

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 3 min read
Blog Human challenge trials Respiratory viruses

UK Life Sciences Sector Plan 2025: What it Means for the Future of Clinical Research

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 9 min read
Blog Human challenge trials Infectious diseases

The UK Regulatory Competitiveness in an ever changing world

Andrew Catchpole
Andrew Catchpole Chief Scientific Officer
10 Apr 2026 4 min read

    Virology, immunology, molecular, and bioanalytical assays optimised for challenge models.

    Yes, with validation packages and regulatory‑ready reporting.
    Integrated clinical‑lab workflows ensure rapid processing and interim releases. 
    Yes, for emerging pathogens and new challenge models.
    Yes, ensuring high‑quality, reliable data.

    Meet our team

    hVIVO is led by a dynamic group of experts in their respective fields who are driving excellence throughout the organisation.

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    Elisa Masat

    Principal Development Scientist

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    Martin Larke

    Principal NGS Biostatistician

    Dariush Pashazadeh

    Cell Culture Manager

    Bring your challenge model to life with expert scientific support

    Contact Us