Adults receiving the influenza (flu) vaccine who may also need COVID-19 booster vaccines Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Study participants will be randomly allocated to receive one of the following at visit 1 at the same time as their second COVID-19 vaccine (either ChadOx1-nCOV-19 (AstraZeneca/Oxford) vaccine or BNT16
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Received one dose of either: 2.1. ChAdOx1 vaccine, 56 to 90 days prior to trial enrolment 2.2. BNT162b2 vaccine, 28 and 90 days prior to trial enrolment 3. Agree to refrain from blood donation in the 7 days following vaccination (at both visits 1 and 2) 4. Willing to allow their General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the trial 5. Willing to allow investigators to discuss their medical history and confirm vaccination status with their GP, and access all medical records when relevant to trial procedures 6. Willing and able to give written informed consent for participation in the trial 7. Able to use and has access to an electronic device (such as a laptop, tablet, or smartphone) to complete trial procedures (such as the e-diary) 8. Able and willing to comply with all trial requirements, in the Investigator’s opinion
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 07/05/2021: 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1 2. Administration of immunoglobulins and/or any blood products within three months before visit 1 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients) 4. Bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture and any history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome. Those who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca. 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban) 6. Suspected or known current alcohol or drug dependency 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data 8. Current, active, and progressive neurological disorders (such as multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion 9. Scheduled elective surgery during trial participation if this interferes with the study protocol 10. Participated in another research trial involving an investigational product in the 12 weeks prior to visit 1, or if receipt of any IMP is planned during the trial period 11. Acute, ongoing respiratory illness (moderate or severe illness, with or without fever) at visit 1 12. Fever (oral temperature >37.8°C) at visit 1 Previous exclusion criteria: 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1 2. Administration of immunoglobulins and/or any blood products within three months before visit 1 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients) 4. Bleeding disorder (for example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban) 6. Suspected or known current alcohol or drug dependency 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data 8. Current, active, and progressive neurological disorders (such as multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion. 9. Scheduled elective surgery during trial participation if this interferes with the study protocol 10. Participated in another research trial involving a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of =1 solicited systemic reaction measured using an electronic diary completed by participants in the 7 days following visit 1. Solicited systemic adverse events include fever, feverishness, chills, joint pains, muscle pains, fatigue, headache, malaise, nausea, vomiting, and diarrhoea. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Type and severity of solicited adverse reactions (systemic or local reaction) measured using an electronic diary completed by participants in the 7 days following visit 1 2. Unsolicited adverse reactions measured using an electronic diary completed by participants during trial participation 3. Medically attended events or serious adverse events (SAEs) measured using an electronic diary completed by participants during trial participation 4. Response to the second dose of COVID-19 vaccine measured using anti-spike protein immunoglobulins in blood samples taken at visit 1 and 2 5. Response to the second dose of COVID-19 vaccine measured using neutralising antibodies against SARS-CoV-2 in blood samples taken at visit 1 and 2 6. Response to influenza vaccine measured using haemagglutination inhibition assay in blood samples taken at visits 1, 2, and 3 7. Mucosal immune responses to COVID-19 vaccines in saliva measured using an assay of saliva samples collected at visits 1, 2, and 3 8. Success of participant blinding measured using the participant completed Bang Blinding Index at visit 3 9. Participant willingness to receive concomitant influenza and COVID-19 vaccinations in the future as reported by participants at visit 3 10. Days off work for participants in employment as reported by participants at visit 3 | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactRajeka Lazarus
Outcome results
None listed