Comparing COVID-19 vaccine schedule combinations – stage 2
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN27841311
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34883053/ Immunogenicity, safety, and reactogenicity results (added 10/12/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37028454/ Persistence of immune response (added 11/04/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1072
1. Participant is willing and able to give written informed consent for participation in the trial
2. Male or female, aged 50 years or above and in good health as determined by a trial clinician. Participants may have well-controlled or mild-moderate comorbidity
3. Has received one dose of the prime/boost schedules being studied via the UK COVID-19 vaccination programme at a timing to allow boost dose given in the trial to fall between days 56-84 post-prime. Evidence of this will be gathered from medical history and/or medical records.
4. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation
5. In the Investigator’s opinion, is able and willing to comply with all trial requirements
6. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial
7. Willing to allow investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures
8. Agreement to refrain from blood donation during the course of the study
1. Receipt of any vaccine (licensed or investigational) within 30 days before enrolment (1 week for licensed seasonal influenza vaccine or pneumococcal vaccine)
2. Previous receipt of two or more COVID-19 vaccine doses
3. Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines other than ChAdOx1 nCoV-19)
4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines
5. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days)
6. History of anaphylaxis, allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Pfizer vaccine), as specified in the UK Immunisation ‘Green Book’ COVID-19 vaccine chapter
7. Pregnancy, lactation or willingness/intention to become pregnant within 3 months post boost vaccine
8. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). This does not include recurrence prophylaxis treatment in those who have no evidence of active disease e.g. hormonal therapy in hormone-sensitive cancers.
9. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
10. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
11. Suspected or known current alcohol or drug dependency
12. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
13. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, rheumatological disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed)
14. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion
15. History of laboratory-confirmed COVID-19 prior to enrolment (e.g. history of SARS-CoV-2 detection by PCR or antibody to SARS-CoV-2)
16. Significant renal or hepatic impairment
17. Scheduled elective surgery requiring overnight admission and/or general anaesthetic during the trial
18. Participant with a life expectancy of less than 6 months
19. Participants who have participated in another research trial involving an investigational product in the past 12 weeks
20. Insufficient level of English language to undertake all study requirements in the op
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The immune response to immunisation with a heterologous or homologous boost of a COVID-19 vaccine in participants seronegative to SARS CoV-2 nucleocapsid IgG at enrolment, measured with immunogenicity (quantity of anti-spike immunoglobulins measured with ELISA) at Day 28
- Secondary Outcome Measures
Name Time Method