Real-world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England
| ISRCTN | ISRCTN87123098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87123098 |
| IRAS number | 300259 |
| Secondary identifying numbers | D8111R00007, IRAS 300259 |
- Submission date
- 22/06/2021
- Registration date
- 24/08/2021
- Last edited
- 19/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The Oxford/Astrazeneca COVID-19 vaccine has shown to be highly effective in studies before it used widely. This study aims to find the effectiveness of the vaccine in England.
The UK has been one of the most significantly affected countries, with over four million cases and over 150,000 deaths at the time of writing. Vaccines against COVID-19 are an important measure in reducing the ongoing spread and severity of the disease in England. The Oxford/Astrazeneca vaccine against COVID-19 has been widely used but limited data exists on its real-world effectiveness, particularly amongst different age groups. Also the impact of a single dose compared to two doses and the time interval between each dose will be studied.
Who can participate?
Data used for the study will include all the individuals in England.
What does the study involve?
During the study GP data will be combined with hospital data to get an understanding of hospitalisations and deaths due to COVID-19 in people who have received the Oxford/Astrazeneca vaccine compared to those who have not received the Oxford/Astrazeneca vaccine.
What are the possible benefits and risks of participating?
The results of the study will give a better understanding about how to administer the vaccine in the English population in the future.
Where is the study run from?
Nuffield Department of Primary Health Care Sciences of the University of Oxford (UK)
When is the study starting and how long is it expected to run for?
January 2021 to November 2022
Who is funding the study?
AstraZeneca (UK)
Who is the main contact?
Prof Simon de Lusignan, simon.delusignan@phc.ox.ac.uk
Contact information
Public
Nuffield Department of Primary Care Health Sciences
Radcliffe Primary Care Building, Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0002-8553-2641 |
|---|---|
| Phone | +44 (0)1865617283 |
| simon.delusignan@phc.ox.ac.uk |
Study information
| Study design | Observational retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available (retrospective study) |
| Scientific title | Real-world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England: an observational retrospective cohort study using secondary databases to establish the effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England |
| Study acronym | RAVEN |
| Study hypothesis | AZD1222 has been shown to be highly efficacious in pivotal randomized clinical trials (RCT), demonstrating 82% overall efficacy against symptomatic infection and 100% efficacy against severe infection. Recent unpublished data from the phase 3 pivotal trial in the US showed high efficacy (85%) in people 65 years of age or older, and again confirmed 100% efficacy in preventing severe cases. Although a high level of single-dose efficacy has been demonstrated in clinical trials between 3 and 12 weeks and confirmed in early effectiveness studies conducted in the UK, clinical trials and effectiveness study so far have not included detailed vaccine-specific analysis by age group, co-morbidities, nor have they assessed vaccine impact on critical care admission, mortality, and overall outcomes. Thus, it remains important to better understand vaccine effectiveness by ages, time intervals between doses, and also to determine if single-dose effectiveness may extend beyond 12 weeks. It’s also important to assess vaccine effectiveness by age groups and comorbidities for best guidance for COVID-19 immunization programs. The UK is one of the first countries that are introducing mass vaccination campaign for COVID-19 and is currently vaccinating the elderly population starting from the oldest age groups (JCVI advice 2020). Three COVID-19 vaccines were licensed and are being used including the Moderna, the BioNTech/Pfizer, and the Oxford/AstraZeneca vaccines. Vaccination with the BioNTech/Pfizer vaccine started in December 2020 and with the Oxford/AstraZeneca vaccine started in early January 2021. This study is to primarily assess the effectiveness of the Oxford/AstraZeneca COVID-19 vaccine. Given the known high efficacy of the Pfizer vaccine in RCT and RWE studies, the study is also to evaluate the Pfizer vaccine effectiveness as a validation of the study’s methods. |
| Ethics approval(s) | Approved 23/05/2021, London - Bromley Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 (0)207 104 8000; bromley.rec@hra.nhs.uk), ref: 21/HRA/1971 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | This is a retrospective cohort study using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE). The primary care data will be linked with vaccination, hospitalization, COVID-19 test results, mortality data at the national level for the capture of key study variables. Individuals of all ages will be included. People in the vaccinated arm will be compared with two comparator cohorts: a) The concurrent control arm (primary): People not vaccinated with any COVID-19 vaccine from January 2021 onward (for the Oxford/AstraZeneca arm) or from December 2020 onward (for the Pfizer arm) b) The historical control arm (secondary): People during the period from July-December 2020 for primary outcomes or from March-December 2020 for secondary outcomes, before the COVID-19 vaccine was available in England Only the first outcome event, i.e. hospitalization, ICU admission will be considered in the analysis. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxford/AstraZeneca COVID-19 vaccine |
| Primary outcome measure | Measured using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE) at a single time point: 1. Rate of hospitalizations associated with COVID-19 2. Rate of admission to ICU associated with COVID-19 3. Rate of mortality associated with COVID-19 |
| Secondary outcome measures | Measured using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE) at a single time point: 1. Rate of any hospitalizations 2. Rate of any admission to ICU 3. Overall mortality rate |
| Overall study start date | 01/01/2021 |
| Overall study end date | 30/11/2022 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | All patients in England who are present in the integrated health records of NHS Digital TRE and/or Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) database at the start of study period. |
| Participant inclusion criteria | 1. People in England who have received at least one dose of the Oxford/AstraZeneca COVID-19 vaccine (the AstraZeneca vaccine arm) or at least one dose of the Pfizer COVID-19 vaccine (the Pfizer vaccine arm) 2. People in England who were not vaccinated with any COVID-19 vaccine during the same time period (concurrent control arm) or during March-December 2020 (historical control arm) who were matched to the vaccinated individuals by age, gender, region, and comorbidity 3. All ages |
| Participant exclusion criteria | Primary analysis: People with a history of COVID-19 infection (confirmed by RT-PCR or not) prior to vaccination. This group of people is not excluded in the sensitivity analysis. |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 30/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Chancellor, Masters and Scholars of the University of Oxford
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor information
Industry
Biopharmaceutical Medicine, Respiratory and Inflammation
One MedImmune Way
Gaithersburg, MD
20878
United States of America
| Phone | +1 (0)3013985406 |
|---|---|
| trung.tran1@astrazeneca.com | |
| Website | http://www.astrazeneca-us.com/home/ |
"ROR" |
https://ror.org/043cec594 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We anticipate to disseminate the study findings to the public in the format of abstract /poster / presentation at congresses, peer-reviewed scientific manuscripts, and press releases as appropriate. Results will also be shared with relevant public health bodies such as JCVI/PHE. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. The participant level data will be securely hosted within the NHS Digital Trusted Research Environment. The data cannot be shared according to the data sharing agreement between NHS Digital and University of Oxford. Researchers interested in the participant data can obtain the data from NHS digital using their Data Access Request Service. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 30/08/2022.
2. The overall trial end date has been changed from 01/06/2022 to 30/11/2022 and the plain English summary updated accordingly.
02/08/2021: Trial's existence confirmed by London - Bromley Research Ethics Committee.
