Guidance

Clinical evaluation for vaccines

The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)

The Vaccine Development and Evaluation Centre (VDEC) supports scientists at every stage of the vaccine and therapeutic medicine development process.

VDEC’s clinical evaluation team provides expertise in immunological and functional assays used to support clinical trials (Phase I to IV).

Speak to our clinical evaluation team

We work with industry, academia and government. Contact UKHSA today to see how we can help you.

Get in touch

What the clinical evaluation team does

We offer 3 main capabilities. These are:

  • expertise in the development and validation of analytical methods
  • the ability to be able to conduct analysis at high-containment biosafety level (BSL) 3, meaning that neutralisation assays can be conducted using a live virus rather than pseudovirus or surrogates
  • an enhanced quality management system which enables work to be performed to support good manufacturing practice (GMP) and good clinical practice (GCP) studies

These capabilities support the UKHSA’s science strategy. They position us uniquely to support the development of vaccines and therapeutics against potential pandemic threats, and contribute towards the 100 Days Mission.

Our work on COVID-19

We provide live virus neutralisation and other immunological assay data in support of SARS-CoV-2 GCP compliant clinical trials to inform UK government policy decisions, vaccine development and licensure.

We isolate and introduce SARS-CoV-2 variants of concern into our analytical methods, enabling an assessment of the potential for these variants of concern (VOCs) to escape vaccines currently in use in the UK.

How UKHSA’s Vaccine Development and Evaluation Centre use microneutralisation assays (MNA)

Current priorities

Our current priorities include:

  • the qualification of seasonal influenza assays (hemagglutination inhibition assay (HAI), microneutralisation, and enzyme-linked immunosorbent assay (ELISA)) to assist in preparedness to manage a potential avian influenza pandemic
  • qualifying assays for respiratory syncytial virus (RSV) to support the testing and deployment of current and new vaccines

How we work with partners

We have the ability to deploy our fully-trained workforce and GxP compliant facilities. We offer these services on a commercial basis to partners from non-governmental organisations (NGOs) and industry to support strategic product development goals.

Scientist evaluating the results from a qualified microneutralisation assay

Updates to this page

Published 20 May 2024
Last updated 16 July 2024 + show all updates
  1. Added the VDEC form link.

  2. Added video.

  3. First published.

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