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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Carla
Solórzano Gonzalez
+44 (0)1865 611400
carla.solorzanogonzalez@paediatrics.ox.ac.uk
Prof
Maheshi N
Ramasamy
+44 (0)1865 611400
Maheshi.Ramasamy@paediatrics.ox.ac.uk
Prof
Daniela
Ferreira
+44 (0)1865 611400
Daniela.Ferreira@paediatrics.ox.ac.uk
Respiratory infections, respiratory syncytial virus and pneumococcus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This study is looking at two different germs: a bacterium called Streptococcus pneumoniae (‘pneumococcus’, Spn) and a virus called Respiratory syncytial virus (RSV). These germs can cause a variety of symptoms from cold-like illnesses to chest infections or sepsis. When someone is exposed to both, which is very common in winter, it might affect how likely they are to develop an infection or how serious their symptoms are. It is important to understand this relationship better so that future studies on treatments or vaccines can be performed.
The study aims to understand how RSV and pneumococcus interact in the nose of healthy adult volunteers. The knowledge generated in this project could be used to help develop new interventions such as anti-virus agents and drugs targeting the host body response.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Research participant:1.1. 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) 1.2. Participated in a previous Spn6B EHPC study < = 3 years or an Spn3 EHPC study < = 1 year before screening 2. Unable to travel to outpatient clinic for visits without using public transport3. Unable to wear an FFP2 mask4. Nasal carriage: Participants who have natural pneumococcal or RSV-A nasal carriage identified at visit 1 will be excluded before randomisation (see table 2A).5. Vaccination: 5.1. No live vaccination within four weeks prior to enrolment (defined as time of first inoculation)5.2. Previous pneumococcal or (investigational) RSV vaccination (including in a research study)6. Allergy to beta-lactam antibiotics (including penicillin and amoxicillin)7. Medical history leading to increased risk of severe infection, illness including but not limited to:7.1. Asplenia or dysfunction of the spleen7.2. Chronic respiratory disease (e.g. asthma [requiring medication (including salbutamol inhaler) within last 12 months], COPD, bronchiectasis and sleep apnoea)7.3. Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) – controlled and stable hypertension may be included7.4. Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, requires dialysis)7.5. Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis)7.6. Chronic neurological disease that limits mobility, bulbar or respiratory function (including stroke, Parkinson’s disease, dementia and multiple sclerosis)7.7. Diabetes mellitus (including diet controlled)7.8. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid, Roaccutane, or disease modifying anti-rheumatoid drugs therapy (for more than 7 consecutive days within the 3 months prior to enrolment).7.9. Individuals with cochlear ear implants7.10. Individuals with major cerebrospinal fluid leaks (e.g. following traumatic, major skull surgery, or requiring CSF shunts)7.11. Subjects with known or suspected immune deficiency (e.g. known IgA deficiency, immotile cilia syndrome, or Kartagener’s syndrome)7.12. History of frequent nose bleeds 7.13. Bleeding disorders8. Current medical issues8.1. Acute upper respiratory tract infection in the four weeks preceding recruitment (as per definition in Annex 1)8.2. Any uncontrolled medical or surgical condition (e.g. mental health conditions, epilepsy, narcolepsy or chronic pain) at the discretion of the study doctor9. Any major pneumococcal illness or pneumonia requiring hospitalisation in the last 10 years10. Medication10.1 Any medication that may affect the immune system in the last 3 months (e.g. systemic steroids [IM/IV], Roaccutane, disease modifying anti-rheumatoid drugs)10.2 Long-term antibiotic use10.3 Recipient of monoclonal antibodies for any indication10.4 Recipient of blood transfusion products within the last year10.5 Any medication that may affect the coagulation system in the last 3 months (excluding aspirin)10.6 Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 1 month11. Maternal 11.1. Female participants who are pregnant11.2. Female participants who are lactating11.3. Female participants who intend to become pregnant during the study11.4. Female participants unable to take contraception measures during the study (from consent to final study visit at day 60)12. Direct caring role or share living accommodation with individuals at higher-risk from infection12.1. Children < = 3 years of age12.2. Adults > 65 years old12.3. Adults with chronic ill health or immunosuppression12.4. Adults classified as clinically extremely vulnerable by the NHS13. Health-care worker14. Smoking14.1. Current or ex-smoker (regular cigarettes/cigars/e-cigarette/vaping/smoking of recreational drugs) in the last 6 months14.2. Previous significant smoking history (more than 5 cigarettes per day for 20 years or the equivalent [i.e. > 5 pack years]). 15. Current alcohol and recreational drug use15.1. Regularly drinks > = 3units/day (male) or > = 2units/day (female)15.2. Regularly uses recreational drugs15.3. Participants may be excluded at the discretion of the research clinician16. Significant mental health disorders: Uncontrolled condition or previous admission to a psychiatric unit (at the discretion of the research clinician) which would impair the participants ability to safely participate in the study17. Overseas travel planned within the study period (60 days after primary challenge)18. Participants FBC results do not meet the required criteria on screening bloods
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Daniela
Ferreira
+44 (0)1865 611400
Daniela.Ferreira@paediatrics.ox.ac.uk
Prof
Maheshi N
Ramasamy
+44 (0)1865 611400
Maheshi.Ramasamy@paediatrics.ox.ac.uk
Dr
Carla
Solórzano Gonzalez
+44 (0)1865 611400
carla.solorzanogonzalez@paediatrics.ox.ac.uk
The study is sponsored by University of Oxford and funded by Pfizer.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.