Biobank

OVG has been collecting samples from trial participants for 30 years, and over this time a huge library of retained samples has been kept and used for future research. Since the introduction of the Human Tissue Act in 2006 explicit consent for this storage and use has been essential. OVG began obtaining consent for storage of leftover serum samples shortly before the act was introduced, and setup a research protocol for use of the samples for ongoing research into immune responses. In 2009 the Oxford Vaccine Centre Biobank was initiated (replacing the previous protocol), with the primary objective of retaining a DNA sample paired to the serum samples to facilitate investigation of the genetic polymorphisms involved in immune responses. This is an ethically approved Research Tissue Bank (RTB), which in 2016 was amended to include biological samples containing cells and was registered under University Human Tissue Authority (HTA) licence 12217. RTB approval is granted for 5 years at a time, and has been successfully renewed twice, in 2016 and 2021. The OVC Biobank protocol can only retain leftover samples which were collected for the purpose of the clinical trial participants were taking part in.

The Jenner Institute Vaccine Trials unit (JVT) are also able to take consent from their trial participants to store samples under the OVC Biobank, as are OVG study sites. The Biobank has ethical approval to release samples to Oxford researchers for projects meeting the objectives of the Biobank without further ethical review. Researchers external to the University wishing to use samples are able to do so, but must have their own ethical approvals in place for the use of the samples. In either case, research requests require an internal review and approval process by the Biobank team. Once approved, the sample management team co-ordinate the physical release and shipment of the samples.

In addition to samples adopted under Biobank, samples containing cellular material which are imported for use or storage must be registered under HTA licence. This requires confirmation of the purpose of holding the samples and confirmation that consent is in place for that purpose. The majority of the samples held directly under the licence are from studies conducted by OVG in Nepal and Brazil.

The Biobank Team is comprised of a number of Biobank investigators, Senior QA and Sample Compliance Manager (also collection responsible officer under HTA licence), and a Project Manager, working closely with the Sample Management Team at OVG, Human Tissue Governance (HTG) at RGEA, a Sample Compliance manager at JVT and the Senior Nursing team at OVG for consent training.

Sample Management

The Oxford Vaccine Group has a Sample Management Team made up of 5 sample management technicians and a Clinical Trial Sample Manager. In addition, there are two Laboratory database managers who are overseeing the implementation of the new OpenSpecimen database for the cataloging and tracking of all clinical trial sample holdings. The team is responsible for the oversight of all OVG freezers and Liquid nitrogen tanks. Currently there 50 freezers and 4 LN2 tanks that are located across several locations including Milton Keynes, Osney Meade, Distribution Centre on Old Road Campus, CCVTM building Level 1 and 2 and the IDRM building Level 2. The holdings contain samples from current studies managed by the research teams, historical study samples managed through the OVC Biobank team and imported human samples held under HTA licence.