NHS Digital Data Release Register - reformatted
Valneva Austria Gmbh projects
- A PHASE I/II RANDOMIZED, TWO PARTS, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF AN INACTIVATED, ADJUVANTED SARS-COV-2 VIRUS VACCINE CANDIDATE (VLA2001), AGAINST COVID-19 IN HEALTHY SUBJECTS
19 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
A PHASE I/II RANDOMIZED, TWO PARTS, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF AN INACTIVATED, ADJUVANTED SARS-COV-2 VIRUS VACCINE CANDIDATE (VLA2001), AGAINST COVID-19 IN HEALTHY SUBJECTS — DARS-NIC-418208-J1Y6J
Type of data: information not disclosed for TRE projects
Opt outs honoured: No - consent provided by participants of research study, Identifiable (, )
Legal basis: Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 s261(2)(c)
Purposes: Yes (Commercial)
Sensitive: Non Sensitive, and Non-Sensitive
When:DSA runs 2020-12-01 — 2021-11-30 2020.12 — 2021.02.
Access method: One-Off
Data-controller type: VALNEVA AUSTRIA GMBH
Sublicensing allowed: No
- Permission to Contact
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, Valneva Austria GmbH, by NHS Digital as a data processor for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by Valneva Austria GmbH.
Data secured from individuals as a result of being contacted by the study is not covered within this agreement. This data relates solely to Valneva and not NHS Digital.
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 (PtC) 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 CV19 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 health question 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 Valneva Austria GmbH, will be sending the email to eligible participants.
This request relates specifically to a vaccine trial.
This is a multi-center, 3-arm randomized dose finding Phase I/II study in UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against COVID-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. The results will provide valuable information on safety and best dosage for optimal immune response.
The primary objective of this study is to evaluate the tolerability, safety and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 vaccine candidate VLA2001 up to 14 days after completion of a two-dose schedule in healthy adults aged 18 to 55 years.
The secondary objectives are to determine the optimal dose level of the inactivated, adjuvanted SARS-CoV-2 vaccine candidate VLA2001 in healthy adults aged 18 to 55 years and to evaluate tolerability, safety and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 vaccine candidate VLA2001 up to 6 months after the last vaccination in healthy adults aged 18 to 55 years.
The exploratory objective is to evaluate cellular immune response after vaccination with the inactivated, adjuvanted SARS-CoV-2 vaccine candidate VLA2001 up to 6 months after the last vaccination in healthy adults aged 18 to 55 years.
The initial mailout will aim for around four / five times the number of potential participants to be recruited and therefore the estimate is for 600 / 750 to be contacted.
The data will be used in support of the development of a commercial vaccine that, should the research prove successful, will generate income for Valneva Austria GmbH to cover both the development costs of the vaccine and also generate profit for that organisation.
The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which:
• Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent.
• Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials – thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.
• Reduces burden on research staff in identifying and contacting potential clinical trial participants.
• Supports 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.
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 vaccine against COVID 19.
NHS Digital will extract a list of patients meeting the following criteria, where that criteria can be ascertained using the PtC registry:
Subjects who meet ALL of the following criteria are eligible for the study:
* Subject is 18 to 55 years of age on the Day of screening (Visit 0).
* Subject who has a smart phone and is willing and able to install and use the eDiary.
* Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
* Subject is generally healthy as determined by the Investigator’s clinical judgement based on medical history, physical examination and screening laboratory tests.
* Subject has a Body Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at screening (Visit 0).
* If subject is of childbearing potential:
* Subject has practiced an adequate method of contraception (see below) during the 30 days before screening (Visit 0).
* Subject has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively.
* Subject agrees to employ adequate birth control measures up to Day 106 (Visit 5). This includes one of the following measures:
* Hormonal contraceptives (e.g. implants, birth control pills, patches).
* Intrauterine hormone-release systems and intrauterine device.
* Barrier type of birth control measure (e.g. diaphragms, cervical caps).
* Vasectomy in the male sex partner ≥ 3 months prior to first vaccination.
* Same sex relationships.
Subjects who meet ANY of the following criteria are NOT eligible for this study:
1. Clinically significant infection or other acute illness, including fever ≥ 38°C within 48 hours prior to the planned study vaccination.
2. History of laboratory-confirmed SARS-CoV-2 infection.
3. Subject had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0).
4. Subject has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
5. Subject has an acute or recent infection not due to SARS-CoV-2 (and who is not symptom-free in the week prior to the Screening Visit (Visit 0).
6. Subject has a history of SARS-CoV-1 or MERS infection (self-reported)
7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
8. Subject has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination. Subjects will be encouraged to receive this vaccination at least 7 days after their study vaccine.
9. Subject has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.
10. Subjects with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions (e.g. cardiovascular, respiratory, neurologic, psychiatric, or rheumatologic conditions) that pose a risk for participation or completion of the study, based on Investigator’s clinical judgement. Examples include subjects with poorly controlled or unstable underlying disease, ongoing suspected or active inflammation, poor compliance with pharmacologic treatment, or presence of high-risk comorbidities (e.g. significant cardiopulmonary disease).
11. Subjects with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected, including those with any of the following risk factors:
• Diabetes mellitus.
• Chronic liver disease.
• Chronic pulmonary disease.
The inclusion and exclusion criteria noted above is based on the information provided by cohort members on the permission to contact dataset (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 sites during the Screening phase.
NHS Digital will identify all individuals within the PtC dataset meeting the relevant criteria and will extract their names, email addresses and postcodes.
It is not known in advance how many individuals meeting the above criteria will have records in the PtC dataset. The number may be amended and the process may be repeated depending on the level of response. In the event of the trial not achieving a suitable balance in recruited participants, such as an uneven ratio of males to females, subsequent mail outs may restrict the required criteria to a greater degree than previously, for example, only requesting details for male participants as opposed to both males and females. This could encompass any part of the criteria, such as age, gender, ethnicity or location and various others, depending on how the recruitment progresses.
NHS Digital will write to the individuals in the subset inviting them to participate within the trial using ethically approved text provided by Valneva Austria GmbH. The email 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 email 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 register 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 Permission To Contact 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 site. Once the data is received at NHS Digital then NHS Digital become controller for that data in their existing role as controller of the Permission To Contact Registry.
Due to the nature of trial recruitment sites, they often only become confirmed as sites very close to recruitment, and so NHS Digital will leave the responsibility with the lead site / data controller to appointment data processors themselves under their own due diligence. This practice aligns with their obligations under GDPR as a data controller and the emphasis will be on the lead site / data controller to appoint appropriate data processors on their behalf. Ordinarily NHS Digital would carry out these checks, but attempting to do so for this service would cause unnecessary delay to the initial application, as well as potentially multiple and costly amendments thereafter. Therefore all recruitment sites / data processors and their processing activities will be covered under a suitable processing agreement between themselves and the lead site / data controller which does not require NHS Digital’s inclusion. Specific details of recruitments sites, such as key contact, location, will therefore not be made known to NHS Digital unless there is a specific reason to do so.
Additionally, Valneva Austria GmbH have an appropriate data processing agreement in place with Pharm-Olam to support the recruitment into the trial under Valneva Austria GmbH’s controllership. Pharm-Olam will not have access to any of the data being disseminated by NHS Digital under this agreement.
No other processing of the data will take place and the data will not be linked with information from any other sources.
Valneva Austria GmbH will not have access to any of the data being disseminated by NHS Digital under this agreement.