COV-COMPARE: A study to compare the VLA2001 and AZD1222 vaccines against COVID-19 in adults
| ISRCTN | ISRCTN79815558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79815558 |
| EudraCT/CTIS number | 2021-000522-97 |
| IRAS number | 294164 |
| Secondary identifying numbers | VLA2001-301, IRAS 294164 |
- Submission date
- 26/04/2021
- Registration date
- 27/04/2021
- Last edited
- 07/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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.
Valneva’s COVID-19 vaccine candidate is called VLA2001. The aim of this study is to compare the immune response to the VLA2001 vaccine to the AZD1222 vaccine in adults aged 30 and older, and to evaluate the safety and tolerability of VLA2001 in adults aged 18 and older.
Who can participate?
Adults aged 18 and older who have not received any COVID-19 vaccination yet, regardless of whether they had been infected by SARS-CoV-2 before or not. Please visit https://www.ukcovid19study.com for more information.
What does the study involve?
Participants are randomly allocated to receive either the VLA2001 or AZD1222 vaccine. The participants and treating doctors will not know which of the two vaccines will have been given. The aim is to compare the immune response and safety of the two vaccines, and to establish a robust safety database for VLA2001. Participants will receive VLA2001 at the dose selected based on the results of the first study. The vaccination schedule will be aligned between the two vaccines, i.e. vaccinations will occur on Days 1 and 29, and follow-up visits will be conducted for 1 year.
What are the possible benefits and risks of participating?
This is the second study in human participants and the clinical benefits of VLA2001 have not yet been established. Although the vaccine might induce immune responses that may be protective, participants might not experience any direct benefit from taking part in this study. The information obtained from this study may help prevent future participants from contracting COVID-19 and will provide important information about how well people respond to VLA2001. There may be risks to being in this study from the study vaccine or from some of the procedures or tests carried out in this study.
Where is the study run from?
Valneva (Austria)
When is the study starting and how long is it expected to run for?
July 2020 to June 2022
Who is funding the study?
Department of Health and Social Care (UK)
Who is the main contact?
Christian Taucher
VLA2001-301@valneva.com
Contact information
Scientific
Campus Vienna Biocenter 3
Vienna
1030
Austria
| Phone | +43 (0)1 206 20 2020 |
|---|---|
| VLA2001-301@valneva.com |
Study information
| Study design | Randomized observer-blind controlled superiority Phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Available at https://www.ukcovid19study.com |
| Scientific title | A randomized, observer-blind, controlled, superiority study to compare the immunogenicity against COVID-19 of the VLA2001 vaccine and the AZD1222 vaccine in adults |
| Study acronym | COV-COMPARE |
| Study hypothesis | The purpose of this study is to compare the immunogenicity of the VLA2001 vaccine to the AZD1222 vaccine in adults aged 30 years and older; and to evaluate the safety and tolerability of VLA2001 in adults aged 18 years and older. |
| Ethics approval(s) | Approved 20/04/2021, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8221, +44 (0)207 104 8063; gmsouth.rec@hra.nhs.uk), REC ref: 21/NW/0125 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | About 3000 participants aged 30 years and above will be randomized via an Interactive Response System (IRS) in a 2:1 ratio to receive two intramuscular recommended doses of either VLA2001 (n=2000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The two doses of vaccination for both vaccines will be administered 28 days apart on Days 1 and 29. Participants will be followed up in the study for approximately 11 months after their second vaccination. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | VLA2001, AZD1222 |
| Primary outcome measure | Immunogenicity: 1. Immune response after completion of a two-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies measured using a neutralization assay on Day 43 Safety: 2. Frequency and severity of any Adverse Events (AE) collected during study visits up to Day 43 post-vaccination |
| Secondary outcome measures | Immunogenicity: 1. Proportion of participants with seroconversion measured using a neutralization assay on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365 2. Immune response, as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies measured using a neutralization assay on Day 8 (age 55+ only), Day 29, Day 71, Day 208 and Day 365 3. Immune response, as determined by the GMT of IgG antibodies to SARS-CoV-2 S-protein measured using an Enzyme-Linked Immunosorbent Assay (ELISA) on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365 4. T-cell responses assessed using T-spot assay and/or intracellular cytokine staining at selected timepoints (yet to be defined) in a subset of participants Safety: 5. Frequency and severity of solicited injection site and systemic reactions captured using electronic diaries within 7 days after each and after any vaccination 6. Frequency and severity of any AE collected during study visits during the entire study period 7. Frequency and severity of any unsolicited AE collected during study visits until Day 43 8. Frequency and severity of any unsolicited vaccine-related AE collected during study visits until Day 43 9. Frequency and severity of any serious adverse event (SAE) collected during study visits during the entire study period 10. Frequency and severity of any adverse event of special interest (AESI) collected during study visits during the entire study period |
| Overall study start date | 20/07/2020 |
| Overall study end date | 30/06/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4000 |
| Participant inclusion criteria | 1. Participants must have read, understood, and signed the informed consent form (ICF) 2. Participants of either gender aged 18 years and older at screening 3. Medically stable 4. Must be able to attend all visits of the study and comply with all study procedures 5. Women of childbearing potential (WOCBPs) must be able and willing to use at least one highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine 6. WOCBPs must have a negative pregnancy test prior to each vaccination |
| Participant exclusion criteria | 1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration 2. History of allergy to any component of the vaccine 3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever >100 °F (>37.8 °C) 48 hours before vaccination 4. Participant has a known or suspected defect of the immune system 5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome 6. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site 7. History of drug dependency or current use of drug abuse or alcohol abuse at screening 8. Significant blood loss (> 450 ml) or has donated one or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1) 9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture 10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition 11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer Prior/concomitant therapy: 12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study 13. Receipt of medications and or vaccinations intended to prevent COVID-19 14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1) Others: 15. Any member of the study team or sponsor 16. An immediate family member or household member of the study’s personnel |
| Recruitment start date | 28/04/2021 |
| Recruitment end date | 03/06/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
60 St Michaels Hill
Bristol
BS2 8DX
United Kingdom
Edgbaston
Birmingham
B15 2WB
United Kingdom
Level 6, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE1 4LP
United Kingdom
Southampton
SO16 6YD
United Kingdom
Derriford
Level 2
MSCP
Bircham Park Offices
Plymouth
PL6 5FP
United Kingdom
Jenner Wing, St George’s
Cranmer Terrace
London
SW17 0RE
United Kingdom
Chelsea
London
SW10 9NH
United Kingdom
170 Tottenham Court Road
London
W1T 7HA
United Kingdom
London
NW3 2QG
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Walsgrave
Coventry
CV2 2DX
United Kingdom
Cottingham Road
Corby
Northampton
NN17 2UR
United Kingdom
Queen's Medical Centre Campus
Derby Road
Nottingham
NG5 1PB
United Kingdom
Prescott Street
Liverpool
L7 8XP
United Kingdom
Salford
M6 8HD
United Kingdom
Gawber Road
Barnsley
S75 2EP
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
5th Floor
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
London
EN3 4GS
United Kingdom
Rochdale
OL11 4AU
United Kingdom
Preston
PR1 6YA
United Kingdom
Guildford
GU2 7XX
United Kingdom
Ward 3
Royal Walk
Cheadle
ST10 1NS
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Bristol
BS10 5NB
United Kingdom
Sponsor information
Industry
Campus Vienna Biocenter 3
Vienna
1030
Austria
| Phone | +43 (0)1 206 20 0 |
|---|---|
| info@valneva.com | |
| Website | http://www.valneva.com/en/ |
"ROR" |
https://ror.org/03xk4a758 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Health & Social Care, DH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data-sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
07/06/2021: The recruitment end date was changed from 27/05/2021 to 03/06/2021.
12/05/2021: The trial participating centres Western General Hospital and North Bristol NHS Trust were added.
26/04/2021: Trial's existence confirmed by the Health Research Authority.
