Duration of natural and hybrid immunity in response to various viruses, including SARS-CoV-2, RSV, and influenza in the nose and airways Infections and Infestations
Conditions
Interventions
This study will recruit up to 200 adults (aged 18 to 85 years) within 8 weeks following a laboratory-confirmed respiratory infection and consent them into the study. The study will include three (3) g
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-85 years of age (inclusive, at the time of consent) 2. Medically healthy, such that according to the investigator's judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable. 3. Fluent in English, ability to understand the procedures and convey any adverse events effectively to the research team 4. Willing and able to provide written informed consent before any study procedures are performed and can understand and comply with the requirements of the study 5. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS) 6. Agree to allow study staff to contact his or her GP or equivalent NHS databases to access the participant’s vaccination records, medical history 7. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study 8. Individuals with laboratory-confirmed respiratory viral infection of interest (swabs to be provided to volunteers by the corresponding site). The viral infections of interest are SARS-CoV-2, hCOV, RSV, Influenza, Rhinovirus and HMPV 9. Agreement to refrain from blood donation during the study 10. For participants of childbearing potential only *: willing to use effective contraception** for the duration of the study AND to have a pregnancy test at screening and bronchoscopy visits
Exclusion criteria
Exclusion criteria: 1. Currently involved in another study unless observational or non-interventional. Exceptions may be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling or nasal sampling. 2. Participants with uncontrolled medical or surgical conditions that may preclude nasal or oral intubation with a bronchoscope or the bronchoscopy itself, in the opinion of the investigator. 3. Participants who have received anti-viral medication or convalescent plasma to treat their respiratory viral infection. 4. 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. 5. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 6. History of any serious psychiatric condition likely to affect participation in the study. 7. Participants who have had previous adverse reactions to benzodiazepines or anaesthetic agents (lidocaine) including reversal agents such as flumazenil. 8. Participants with a full blood count, clotting or renal function level outside of local laboratory reference ranges and deemed as clinically significant by the investigator. 9. Any medication that may affect the coagulation system in the last 7 days (excluding low dose 75 mg aspirin). 10. Participants with very poor venous access. 11. Receipt of blood products or immunoglobulins within 3 months prior to screening. 12. Participants who, in the opinion of the Investigator (or designee), should not participate in this study. 13. Participants with asthma, medicated with steroid inhalers. 14. On long term oxygen therapy (LTOT). 15. Oxygen saturations on screening of 1. 27. Participants with a >20-year smoking pack history. 28. Diagnosis of chronic respiratory disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and breadth of antigen-specific T and B cell responses in the respiratory mucosa and blood after re-stimulation measured using flow cytometry and ELISPOTs at 35 days post infections | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sustainability of T and B cells in the respiratory mucosa and blood measured using flow cytometry and ELISPOTs for 12 months post-infection at 35,126 and 322 days post-infection 2. Assess the cross-reactive potential of T and B cells in respiratory mucosa and blood after stimulation with heterologous antigens measured using flow cytometry at 35-126 post-infection 3. Quantify antibody levels (IgA, IgG, IgM) in respiratory mucosa and blood using MSD/ELISA assays and describe their time kinetics at 35, 126 and 322 days post-infection 4. Frequency of antigen-specific T cells and antibody titres measured using flow cytometry assays, ELISA, and MSD (comparison of generated data primary and secondary objectives 1 and 2) at 35, 126 and 322 days post-infection 5. Levels and type of immunity in individuals with recurrent infection and those with only one infection within the period of participation in the study measured using flow cytometry assays, ELISA, and MSD at 35, 126 and 322 days post-infection 6. Participants age stratification in 2 groups (15-60 years of age and >60 years) measured using data collected in study records and comparison of cellular and humoral immune responses using flow cytometry assays, ELISA, and MSD at 35, 126 and 322 days post-infection | — |
Countries
United Kingdom
Contacts
Public ContactReyna Sara Quintero Barceinas
Outcome results
None listed