nderstanding how two common respiratory infections interact in the nose of healthy adults: Respiratory Syncytial Virus and Streptococcus pneumoniae
- Conditions
- Respiratory infections, respiratory syncytial virus and pneumococcusInfections and Infestations
- Registration Number
- ISRCTN12036902
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 113
1. Healthy adults aged 18-55 years (inclusive, at the time of consent)
2. Fluent spoken English – to ensure a comprehensive understanding of the research project
3. Capacity to provide written informed consent in English
4. Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate contraceptive measures as per UK Clinical Trial Facilitation Group during the study.
5. Willing to provide their household contacts with the Close Contact Screening Information Letter
6. For Phase C, RSV neutralising antibody titre in the lowest 10th percentile of screened participants
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 transport
3. Unable to wear an FFP2 mask
4. 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 spleen
7.2. 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 included
7.4. 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 implants
7.10. 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 disorders
8. Current medical issues
8.1. 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 doctor
9. Any major pneumococcal illness or pneumonia requiring hospitalisation in the last 10 years
10. Medication
10.1 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 use
10.3 Recipient of monoclonal antibodies for any indication
10.4 Recipient of blood transfusion products within the last year
10.5 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 month
11. Maternal
11.1. Female participants who are pregnant
11.2. Female
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of Spn6B detected by classical microbiology in at least one nasal wash sample at any timepoint following Spn6B challenge: e.g Day 2, Day 6, Day 9, Day 14, Day 21 and Day 60
- Secondary Outcome Measures
Name Time Method