COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222 (COV-COMPARE)
SARS-CoV-2 Virus Infection
About this trial
This is an interventional prevention trial for SARS-CoV-2 Virus Infection focused on measuring VLA2001, SARS-CoV-2 Virus Infection, COVID-19, inactivated-adjuvanted SARS-CoV-2 virus vaccine
Eligibility Criteria
Inclusion Criteria:
- Participants must have read, understood, and signed the informed consent form (ICF).
- Participants of either gender aged 12 years and older at screening.
- Medically stable
- Must be able to attend all visits of the study and comply with all study procedures,
- Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine.
- WOCBPs must have a negative pregnancy test prior to each vaccination.
Exclusion Criteria:
- Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration.
- History of allergy to any component of the vaccine.
- 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.
- Participant has a known or suspected defect of the immune system
- Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- 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.
- History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
- Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1).
- History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition.
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:
- 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.
- Receipt of medications and or vaccinations intended to prevent COVID-19.
- Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1).
- Any member of the study team or sponsor.
- An immediate family member or household member of the study's personnel.
Booster Vaccination (Adolescents)
In addition to the above described eligibility criteria, the following criteria must be met:
- Participant has completed the primary vaccination schedule per protocol (i.e. has received 2 study vaccinations within protocol windows).
Sites / Locations
- Barnsley Hospital NHS FT
- University Hospitals Birmingham NHS Foundation Trust
- Blackpool Teaching Hospitals NHS Foundation Trust
- North Bristol NHS Trust
- University Hospitals Bristol and Weston NHS Foundation Trust
- Cambridge Biomedical Research Centre
- Cheadle Community Hospital
- University Hospitals Coventry & Warwickshire
- Western General Hospital, Edinburgh - NHS Lothian
- Epsom and St. Helier University Hospitals NHS Trust
- Queen Elizabeth University Hospital-Glasgow- NHS Greater Glasgow
- Royal Surrey County Hospital NHS Foundation Trust
- University Hospitals of Leicester NHS Trust
- NHS Foundation Trust Royal Liverpool University Hospital
- Barts Health NHS Trust
- Panthera London
- Royal Free London NHS Foundation Trust
- King's College Hospital, Trust College HOspital NHS Foundation Trust
- Chelsea and Westminster Hospital NHS Trust
- St George's University Hospitals NHS Foundation Trust
- NIHR UCLH Clinical Research Facility
- The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital Newcastle
- Northumbria Healthcare NHS Foundation Trust - North Tyneside General Hospital
- Lakeside Healthcare Research
- Nottingham University Hospitals NHS Trust
- University Hospital Plymouth NHS Trust
- Panthera Biopartners Preston
- Panthera Biopartners Manchester
- Northern Care Alliance NHS Group, Salford Royal NHS Foundation Trust
- Southampton University Hospitals NHS Trust
- Royal Cornwall Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Placebo Comparator
VLA2001
AZD1222
VLA2001 - adolescent part
Placebo
<30 years will receive VLA2001; participants aged ≥30 years will be randomised 2:1 to receive VLA2001 or AZD1222
<30 years will receive VLA2001; participants aged ≥30 years will be randomised 2:1 to receive VLA2001 or AZD1222
≥12 to < 18 years will be randomized 1:1 to receive VLA2001 or Placebo
≥12 to < 18 years will be randomized 1:1 to receive VLA2001 or Placebo