ymph node flu and COVID-19 vaccine responses in younger or older adults
- Conditions
- Flu and COVID-19 vaccine responsesInfections and Infestations
- Registration Number
- ISRCTN12928349
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 48
1. Adults aged between 18 to 45 years (inclusive) OR aged 65 years and over
2. Medically stable (i.e., according to investigator's judgement, it is not anticipated that the participant will require hospitalisation within the study period or that they will need to withdraw from the study for medical reasons before completion of protocol-specified follow-up). A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 90 days prior to enrolment.
3. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diaries
4. Willing and able to give informed consent for participation in the study
5. Agree to allow study staff to contact his or her GP or equivalent NHS databases to access the participant’s vaccination records and medical history
6. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study
7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
8. Agree to refrain from blood donation whilst in the study
9. For participants of childbearing potential only (as defined by protocol). Willing to use effective contraception established for the duration of enrolment in the study AND have a negative pregnancy test on the days of screening and study injections.
10. Have received at least a primary (two-dose) schedule of any MHRA, UK-authorised or licenced COVID-19 vaccine.
1. Participation in another research study involving an investigational product, or which includes procedures that could compromise the integrity of this study (such as significant volumes of blood already taken), within the 12 weeks prior to enrolment, or planned participation in such a study within the study period.
2. Body mass index >=35 kg/m²
4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
5. Administration of regular anticoagulation medication likely to induce bruising or bleeding on fine needle aspiration.
6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months, or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within the previous 3 months).
7. History of anaphylaxis in relation to vaccination, or local anaesthetic such as lidocaine.
8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the experimental vaccine or to local anaesthetic such as lidocaine.
9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
10. History of cancer that is not resolved (except basal cell carcinoma of the skin and cervical carcinoma in situ).
11. History of any serious psychiatric condition likely to affect participation in the study.
12. For participants of childbearing potential only: participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study.
13. History of a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
14. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome, or history of heparin-induced thrombocytopenia.
15. History of episodes of capillary leak syndrome.
16. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled co-morbidities are acceptable)
17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units per week.
18. Suspected or known injecting drug use within the 5 years preceding enrolment.
19. Detectable circulating hepatitis B surface antigen (HBsAg).
20. Seropositive for hepatitis C virus (antibodies to HCV).
21. Seropositive for HIV.
22. A history of pericarditis, myocarditis or other cardiac inflammation deemed significant by the investigator
23. Any clinically significant finding on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study.
24. Member of the study team. This is deliberately loosely defined, but at a minimum will include: anyone on the delegation log; anyone who might be anticipated to be placed onto the delegation log in the course of the study; anyone who has access to personal data on study participants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency, phenotype, and function of immune cells in axillary secondary lymphoid tissue and blood after intramuscular immunisation, measured using single-cell ribonucleic acid sequencing (scRNA-seq) to measure cell-by-cell transcriptomes in lymph node cells and/or multiparameter flow cytometry, at Day 0, 7, Day 14 and Day 28 and Day 84 after the study injection
- Secondary Outcome Measures
Name Time Method Reactive lymph nodes defined using ultrasound measurements of secondary lymphoid tissue at Day 0, 7, Day 14, Day 28, and Day 84 after study injection