VidPrevtyn Beta® vaccine effectiveness against COVID-19 hospitalisations in the UK
| ISRCTN | ISRCTN95900937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95900937 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Sanofi (France) |
| Funder | Sanofi Pasteur |
- Submission date
- 20/07/2023
- Registration date
- 24/07/2023
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This study aims to assess the vaccine effectiveness of VidPrevtyn Beta as a booster vaccine against severe COVID-19-related outcomes. This study additionally will assess the effectiveness of the vaccine in at-risk populations such as immunocompromised individuals, the elderly, and pregnant women (pending data availability).
Who can participate?
This study will use a series of de-identified patient datasets in England, accessible through National Health Service (NHS) England (formerly known as NHS Digital).
What does the study involve?
The data analysed will start on March 1, 2018, and end at the time of data extraction (i.e., the latest day of data overlap across required datasets). Two campaign periods will be assessed for this study: The spring campaign and the autumn campaign. Three cohorts will be constituted for both vaccine campaign periods:
1. VidPrevtyn Boosted Cohort: Patients who received VidPrevtyn Beta during the campaign
2. Boosted Cohort: Patients who received another vaccine other than VidPrevtyn Beta during the campaign
3. Un-Boosted Cohort: Patients who did not receive any vaccine during the campaign
Individuals in the VidPrevtyn Boosted Cohort will be matched to those in the Un-boosted Cohort. The follow-up period will begin on the index date and end at the earliest of death, the new vaccine, the outcome of interest, or 6-months after the index date. The index date for the VidPrevtyn Boosted Cohort will be 14 days after receiving the vaccine. The index date for the Un-Boosted Cohort will be the same date as their matched VidPrevtyn Boosted counterpart. Hazard Ratios (HR) of COVID-19-related hospitalization or COVID-19-related death following matching will be performed. Vaccine effectiveness (VE) will be calculated per each outcome. Analyses will be performed for the entire sample, as well as stratified by a selected set of measures which may include, age group, time since last vaccine dose immunocompromised status; groups at a greater risk of poor COVID-19 outcomes (e.g., immunosuppressed, liver cirrhosis, Down’s syndrome, diabetes mellitus), pregnancy status. Individuals in the VidPrevtyn Boosted Cohort will also be matched to those in the Boosted Cohort. HR and VE estimates will be calculated using the same methodology as described previously.
Where is the study run from?
Evidera (USA)
When is the study starting and how long is it expected to run for?
January 2023 to March 2025
Who is funding the study?
Sanofi Pasteur (France)
Who is the main contact?
Dr Mark Yates, mark.yates@evidera.com (UK)
Contact information
Principal investigator
The Ark
Talgarth Road
Hammersmith
London
W6 8BJ
United Kingdom
 ORCID ID |
0000-0001-5449-5211 |
|---|---|
| Phone | None provided |
| mark.yates@evidera.com |
Scientific
The Ark
Talgarth Road
Hammersmith
London
W6 8BJ
United Kingdom
| Phone | None provided |
|---|---|
| mark.yates@evidera.com |
Public
The Ark
Talgarth Road
Hammersmith
London
W6 8BJ
United Kingdom
| Phone | None provided |
|---|---|
| mark.yates@evidera.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational retrospective matched cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | VidPrevtyn Beta® vaccine effectiveness against hospitalization due to SARS-CoV-2 infection – a secondary database study in the UK |
| Study objectives | This is an observational study. It is anticipated that the findings from this study will: 1. Enhance the understanding of vaccine effectiveness of VidPrevtyn Beta as a booster vaccine against severe COVID-19-related outcomes 2. Help assess the effectiveness of the vaccine in at-risk populations such as immunocompromised individuals, the elderly and pregnant women. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The Health Research Authority (HRA) tool was used to assess the need for HRA approval. HRA approval is not required as this study utilized deidentified data and does not include any contact with patients or subjects. |
| Health condition(s) or problem(s) studied | COVID-19 |
| Intervention | This is an observational retrospective matched cohort study using a series of datasets in England, accessible through National Health Services (NHS) England (formerly NHS Digital). The overall study population will consist of individuals in England that were ≥18 years of age as of March 1, 2023. The study period will begin on April 1, 2018, and end six months after the end of the autumn 2023/2024 booster campaign (the study end date is the end of June 2024). Two campaign periods will be assessed for this study: The Spring campaign and the autumn campaign. Three cohorts will be constituted for both vaccine campaign periods: 1. VidPrevtyn Boosted Cohort: Patients who received VidPrevtyn Beta during the campaign 2. Boosted Cohort: Patients who received another vaccine other than VidPrevtyn Beta during the campaign 3. Un-Boosted Cohort: Patients who did not receive any vaccine during the campaign Individuals in the VidPrevtyn Boosted Cohort will be matched to those in the Un-boosted Cohort. The follow-up period will begin on the index date and end at the earliest of death, another COVID-19 vaccine administered, the outcome of interest, or 6-months after the index date. The index date for the VidPrevtyn Boosted Cohort will be 14 days after receiving the vaccine. The index date for the Un-Boosted Cohort will be the same date as their matched VidPrevtyn Boosted counterpart. Hazard Ratios (HR) of COVID-19-related hospitalization or COVID-19-related death following matching will be estimated. Vaccine effectiveness (VE) will be calculated per each outcome. Analyses will be performed for the entire sample, as well as stratified by a selected set of measures which may include, age group, time since last vaccine dose, immunocompromised status; groups at a greater risk of poor COVID-19 outcomes (e.g., immunosuppressed, liver cirrhosis, Down’s syndrome, diabetes mellitus), pregnancy status. Individuals in the VidPrevtyn Boosted Cohort will also be matched to those in the Boosted Cohort. HR and VE estimates will be calculated as described above. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | VidPrevtyn Beta |
| Primary outcome measure(s) |
Vaccine effectiveness of VidPrevtyn Beta against hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in patients who have received at least one additional dose of VidPrevtyn Beta as their last dose, compared with patients who have not received a booster dose measured using patient medical records within the same campaign period |
| Key secondary outcome measure(s) |
Secondary outcome measures are measured using patient medical records: |
| Completion date | 01/03/2025 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 617000 |
| Key inclusion criteria | This study will include all individuals aged 18 years or older who are eligible to receive a VidPrevtyn Beta vaccine. |
| Key exclusion criteria | Individuals <18 years and those who are ineligible to receive a VidPrevtyn Beta vaccine. |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. The data obtained from NHS England for this study will be accessed via a secure data environment (SDE), managed by NHSE. Access to the ‘raw data’ would therefore need to be requested from NHSE. Evidera does not hold or manage this data in-house, and thus cannot make this data publicly available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | Synopsis | 15/06/2023 | 24/07/2023 | No | No |
Additional files
- 43984_Protocol_15June2023.pdf
- Synopsis
Editorial Notes
12/09/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2024 to 01/03/2025.
2. The intention to publish date was changed from 01/09/2025 to 01/03/2026.
3. The plain English summary was updated to reflect these changes.
24/07/2023: Trial's existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA) (UK).
