Phase I Vaccine Study of pEVAC-PS

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the Data Controller, University Hospital Southampton NHS Foundation Trust, by NHS Digital as a Data Processor for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by University Hospital Southampton NHS Foundation Trust.

The following provides background to the Permission to Contact (PtC) Service:

NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020.

This Service enables participants to:

• Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials.

• Provide their permission to be contacted by NHS Digital about progress and outcomes from COVID-19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research.

The data collected from individuals who sign up includes sufficient information to achieve the following purposes:

• Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number of health questions e.g. about whether they have long-term health conditions.

• Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial.

• NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service.

The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as Data Processor acting on behalf of University Hospital Southampton NHS Foundation Trust, will be sending the communication to eligible participants.

This request relates specifically to a vaccine trial. The full title for this study is "A phase I safety, immunogenicity and dose escalation study of the candidate pan-Sarbeco Coronavirus vaccine pEVAC-PS in SARS-CoV-2 immunised UK healthy adult volunteers"

Vaccines that protect against multiple related viruses have been developed using DIOSynVax technology. This broadly protective approach is needed for Coronaviruses such as SARS-CoV-2 and SARS-CoV, two of numerous related viruses that have the potential to cause future outbreaks from zoonotic reservoirs, where pathogens (viruses in this case) in animals can cross over to humans. The pEVAC-PS vaccine was designed to induce highly focussed immune responses against key neutralising antibody targets of the Sarbeco Coronaviruses in order to protect against SARS-CoV-2, SARS-CoV and potential future outbreaks of related Coronaviruses. pEVAC-PS is well-positioned to boost existing, licenced SARS-CoV-2 vaccines and to induce SARS-CoV antibody responses.

DNA code for the virus protein components to be part of the vaccine are processed before being made as plasmid DNA for the vaccine. Plasmid DNA is different to human chromosomal DNA that carries the human genetic code. This vector is a flexible vaccine platform and any combination of antigens can be inserted to produce a different vaccine. DIOSynVax antigen inserts are engineered to be readily transferable to other scale-able vaccine delivery systems, such as Adenoviral or mRNA vectors

This study will use an established needleless vaccine delivery technology to assess the optimal dose required to trigger patients’ cells to produce the antigens, be recognised by participants immune systems and boost antibody titres that will induce durable protection against SARS-CoV-2 and SARS-CoV. Combined with needleless and powerless (no electrical source required) delivery, this platform offers a safe, widely deployable pan-Sarbeco Coronavirus vaccine for large scale immunisation programmes.

The aim is to recruit a total of 36 participants. The initial mailout aimed for around four / five times the number of potential participants to be recruited and therefore the estimate was for around 180 individuals to be contacted via the Permission to Contact (PtC) Service. The aim is still to recruit a total of 36 participants and as of 2nd November 2022, 3,215 invites had been sent via the registry over a period of 10-11 months.

The GDPR legal basis for processing the data is GDPR Article 6 (1) (e). Processing is carried out by an NHS organisation in the public interest, in order to understand and help this patient population in the future. Additionally, under GDPR Article 9(2)(j) processing of Special Category Personal Data is necessary for archiving for research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects.

NHS Digital is content that the purpose of this study is the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in the UK.

However, in the interests of full transparency, it is noted here that the data will be used in support of the development of a commercial vaccine(s) that, should the research prove successful, will generate income for the commercial companies involved, to cover the development costs of the vaccine and also generate profit for that organisation.

This study includes the involvement of the following commercial companies:

- DiosCoVax: is the grant lead and owner of Dios platform technology IP.

- Symbiosis: this is the product manufacturer for this study.

- PHARMExcel: this organisation is the Contract Research Organisation for this study.

None of the above organisations will have access to NHS Digital record-level data. As a result, none of these organisations are considered a Data Controller or Data Processor for this agreement.

NHS Digital will extract a list of patients meeting the following criteria, where that criteria can be ascertained using the NHS Digital COVID-19 Vaccine Research Registry:

Personal Information:

Age

Location

Sex at birth

Ethic Group

Health questions:

Flu Jab

Diabetes

Asthma

Lung conditions

Liver conditions

Heart conditions

Cancer treatment

Bleeding disorders

Immune system disorders

The inclusion and exclusion criteria noted above is based on the information provided by members on the NHS Digital COVID-19 Vaccine Research Registry (where it can be obtained from this dataset ), and is not collected from other NHS data sources. Some of the above inclusion and exclusion criteria will be used by the recruitment sites during the Screening phase. During the screening phase, the study team will use further inclusion and exclusion criteria in order to further filter the potential participants to undertake consent and discuss the trial.

NHS Digital will identify the required number of individuals within the NHS Digital COVID-19 Vaccine Research Registry meeting the relevant criteria and will extract their names, date of birth, email addresses and postcodes.

It is not known in advance how many individuals meeting the above criteria will respond to the invitation. The process may be repeated, with amended numbers, depending on the level of response. This could encompass any part of the criteria, depending on how the recruitment progresses.

NHS Digital will contact individuals in the subset inviting them to participate within the trial using ethically approved text provided by University Hospital Southampton NHS Foundation Trust. The communication will remind the individuals of the background of the Permission to Contact programme and give them the opportunity to state that they do not wish to be contacted again. The communication will also direct volunteers to NIHR’s Be Part of Research website to access study information and regional contact information. Individuals will not be contacted multiple times under this Agreement and NHS Digital will record the fact that the individuals have been contacted to ensure compliance with the maximum number of contacts outlined as part of consent. Furthermore, in order to ensure that NHS Digital are able to update the registry with which participants are registered with an active trial, and therefore prevent them from being invited to any further trials, NHS Digital will be provided with regular updates of those registered participants who have consented. This sharing of information is built into the Permission to Contact signing up information and will also be added to the trial consent and participant information.

Individual trial recruitment sites will supply NHS Digital with details of those who have signed up to take part in their trial so that NHS Digital can suitably capture this information within the NHS Digital COVID-19 Vaccine Research Registry. All data that flows to NHS Digital in this context falls under the controllership of the Data Controller, regardless of whether they themselves are specifically involved in the processing of that data as it flows to NHS Digital. For this agreement there may be flows from each individual recruitment site. Once the data is received at NHS Digital then NHS Digital become controller for that data in their existing role as Data Controller of the NHS Digital COVID-19 Vaccine Research Registry.

No other processing of the data will take place and the data will not be linked with information from any other sources.

University Hospital Southampton NHS Foundation Trust will not have access to any of the data being disseminated by NHS Digital under this agreement.

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

This is expected to result in individuals entering the trials screening process with a view to them participating in the trial with fully informed consent.

The main results from this trial are expected to inform development of a safe and effective multiple vaccine combination against COVID 19.

The primary benefit of using the data will be to allow researchers to identify a suitable cohort and recruit them quickly into the vaccine trial – thus reducing the overall time to recruit into the trials. This is expected to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.

It is expected that this will reduce the burden on research staff in identifying and contacting potential clinical trial participants. It is anticipated this will also support the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.

COVID vaccine trials are ongoing, some progress quickly whereas others (phase 1 trials) are slower as depend on both the phase of pandemic and the speed of regulatory agency approvals – there are currently delays with MHRA approvals and studies will recruit/progress when the protocol amendments have progressed. All studies will generate benefit – either directly impacting the national programme, or via development of future vaccines.