SARS-CoV-2 vaccination for COVID-19 disease safety study
| ISRCTN | ISRCTN95881792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95881792 |
| IRAS number | 286051 |
| Secondary identifying numbers | IRAS 286051 |
- Submission date
- 03/12/2020
- Registration date
- 21/12/2020
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
This is an online study created by MEMO (Medicines Monitoring Unit) Research at the University of Dundee to track any vaccines that are being used to prevent COVID-19 infection. All vaccines are tested for safety and effectiveness on human volunteers in large clinical trials. There are some things that we can only find out once vaccines are being used widely. Initially launching in the UK, and expanding to more countries around the globe, this study will track vaccines to check they are working well. It will be big enough to detect any rare unexpected vaccine side effects. Participation in this study is voluntary and it will not interfere with normal care from participants' GP practices.
Who can participate?
Patients aged 18 or older who have access to a desktop computer, laptop or smartphone or tablet device, and who have a valid unique email address that only they use.
What does the study involve?
Participants sign up to a secure website and consent to take part both before and after they are vaccinated. They provide information about themselves (e.g. demographics, past medical history, medication) and then receive reminder emails monthly (or weekly for 4 weeks after they receive a vaccination or booster) asking them to provide information about their health and wellbeing. Any events of interest will be followed up with the participant, their emergency contact and/or their healthcare professionals.
What are the possible benefits and risks of participating?
There is no immediate benefit for the participants, but they will be contributing to improving the knowledge about the safety and effectiveness of COVID-19 vaccinations.
Where is the study run from?
University of Dundee (UK)
When is the study starting and how long is it expected to run for?
June 2020 to December 2023
Who is funding the study?
University of Dundee (UK)
Who is the main contact?
Wendy Saywood
vac4covid@dundee.ac.uk
Contact information
Scientific
MEMO Research
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 383119 |
|---|---|
| vac4covid@dundee.ac.uk |
Study information
| Study design | Prospective active observational post-authorisation surveillance safety study (PASS) |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | https://www.vac4covid.com |
| Scientific title | SARS-CoV-2 Vaccination for COVID-19 Disease Safety Study (VAC4COVID Study): a prospective, active observational, post-authorisation surveillance safety study (PASS) of vaccines for COVID-19 disease |
| Study acronym | VAC4COVID |
| Study hypothesis | The aim of the study is to monitor the safety and effectiveness of COVID-19 vaccines by gathering information from a large number of participants about their health before and after they are vaccinated. We will do this by collecting health information from study participants. Participants will provide information before and after vaccination. |
| Ethics approval(s) | Approved 28/01/2021, NHS Berkshire B Committee (Reading Business Centre, Fountain House, 2 Queens Walk, Reading, Berkshire, RG1 7QF, UK; +44 (0)207 1048226; berkshireb.rec@hra.nhs.uk), ref: not provided |
| Condition | Safety monitoring for all COVID-19 (SARS-CoV-2 infection) vaccinations |
| Intervention | Participants will be recruited pre and post COVID-19 vaccination and will include people who decide not to be vaccinated. It is an online, observational study where patients fill in initial health and demographic information, details of their vaccination and then complete regular follow-ups recording any serious adverse events. Everything will be done online on a secure website. Follow up will be for at least 1 year but can be extended if required by regulatory authorities or the Sponsor. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | BNT162b2 vaccine (Pfizer-BioNTech) ChAdOx1 vaccine (AstraZeneca vaccine) |
| Primary outcome measure | SAEs reported by participants, emergency contacts and healthcare professionals both prior to and after vaccination for the whole vaccinated and unvaccinated population, as well as for predefined subgroups, during the study observation period. Special attention will be given to AESI, updated lists of which may be produced by regulators/health authorities during the study based on the most recent updates regarding vaccine development and safety. |
| Secondary outcome measures | Reported by participants, healthcare professionals, medical records (including written and electronic records, and national databases, where possible), and emergency contacts during the study observation period: 1. Adverse events prior to and after vaccination for the whole vaccinated and unvaccinated population and in predefined subgroups 2. All-cause mortality rate for the whole study population and predefined subgroups 3. Rates and severity of participant-reported symptomatic COVID-19 infection in vaccinated and unvaccinated cohorts 4. Reported reasons for non-vaccination |
| Overall study start date | 22/06/2020 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20,000 |
| Total final enrolment | 21104 |
| Participant inclusion criteria | 1. Adults aged 18 years and over (participants with primary caring responsibilities for children under the age of 18 may submit information on the child’s behalf with age-appropriate agreement) 2. Valid email address (per adult participant) and able to access and use the internet 3. Subjects willing to nominate at least one, preferably two, emergency contact(s) |
| Participant exclusion criteria | 1. No access to internet enabled devices to enable participation 2. Unable to consent due to incapacity 3. Unwilling or unable to nominate at least one emergency contact |
| Recruitment start date | 03/02/2021 |
| Recruitment end date | 31/01/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
TASC
Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)138 383297 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk/ |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Dundee University, Oilthigh Dhùn Dè
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Stored in repository |
| Publication and dissemination plan | 1. A paper relating to the study protocol will be published in a peer-reviewed journal during the course of the study 2. Planned publication in a high impact, peer-reviewed journal and presented at an international research meeting |
| IPD sharing plan | Current participant level data sharing statement as of 17/01/2025: The dataset will be stored within a user-access controlled database on the MEMO Research server which is part of the University of Dundee secure servers. At the end of the study, it will be archived according to UoD guidelines and accessible on request to Professor I.M.Mackenzie (vac4covid@dundee.ac.uk), for the purpose of audit and regulatory inspection. The analysed data will be part of the publication of the results at the end of the study. Individual-level data will not be made available to ensure that anonymity is maintained. Participants consented to their submitted data being analysed in this way with no individual data being released to avoid identification. Any research group wishing to use the data should apply to the Steering Committee who will have to approve the proposal and ensure that there are no data breaches. Data will be archived for 5 years after the end of the study (31/12/2028). _____ Previous participant level data sharing statement: The dataset will be stored within a user-access controlled database on the MEMO Research server which is part of the University of Dundee secure servers. At the end of the study, it will be archived according to UoD guidelines and accessible on request for the purpose of audit and regulatory inspection. The analysed data will be part of the publication of the results at the end of the study. Individual-level data will not be made available to ensure that anonymity is maintained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Adverse events and overall health and well-being after COVID-19 vaccination results | 01/06/2022 | 08/06/2022 | Yes | No |
Editorial Notes
17/01/2025: The participant level data sharing statement was changed.
30/12/2024: The intention to publish date was changed from 31/12/2024 to 30/04/2025.
16/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 31/01/2023.
2. The overall end date was changed from 31/12/2025 to 31/12/2023.
3. The intention to publish date was changed from 31/12/2026 to 31/12/2024.
4. The target number of participants was changed from 1,000,000 to 20,000.
5. The total final enrolment was added.
6. The plain English summary was updated to reflect these changes.
08/06/2022: Publication reference added.
16/02/2021: The contact email was changed.
09/02/2021: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 15/01/2021 to 03/02/2021.
04/01/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2021 to 15/01/2021
2. The ethics committee details were added.
21/12/2020: Trial's existence confirmed by the University of Dundee.
