Ear, Nose and Throat Respiratory
Conditions
Interventions
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy adults aged 18-50 years. • Fluent spoken English and/or Chichewa. • Capacity to give informed consent • HIV negative • Access to their own mobile telephone
Exclusion criteria
Exclusion criteria: • Currently involved in another study unless observational or non-interventional. • Participant in any previous EHPC trial in past year • Previous pneumococcal vaccination. This can be self-reported or confirmed from the health passport if deemed necessary at clinician discretion. • HIV positive • Allergy to penicillin/amoxicillin • Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease. • Medication that may affect the immune system e.g., steroids, inflammation altering or disease-modifying anti-rheumatoid drugs. • Long term use of antibiotics for chronic infection. • Major pneumococcal illness requiring hospitalisation in the last 10 years. • Other conditions considered by the clinical team as a concern for participant safety or integrity of the study • Significant mental health problems (uncontrolled condition or requiring previous admission to a psychiatric unit) that would impair ability to participate • Direct caring role or close contact with individuals at higher risk of infection; Children under 5 years age, adults with chronic ill health or immunosuppression, hospital patients • Current or ex-smoker (daily cigarettes, daily e-cigarettes/vaping and daily smoking of recreational drugs) in the last 6 months. Participants who smoke 20 cigarettes per day for 20 years or equivalent [>20 pack years]. • Currently pregnant/lactating/ Intending on becoming pregnant during the study • History of or current drug or alcohol abuse; Men should not drink >3 units/day regularly. Women should not drink >2 units/day regularly. • Overseas travel planned in follow up period of study visits • Natural SPN3 colonisation in baseline nasal wash
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of SPN3 in nasal wash by classical microbiology at any time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Carriage duration and density by classical microbiology and PCR. Pneumococcal carriage rate following experimental pneumococcal inoculation with different doses. Musocal immune cell populations and dynamics in nasal cells. Mucosal and systemic SPN3 polysaccharide-specific antibodies at baseline and after SPN3 experimental inoculation. Participant exit interviews | — |
Countries
Malawi
Contacts
Public ContactNeema;Anthony Emeritus Toto;Chirwa
Senior Study coordinator. Malawi Liverpool Wellcome Programme.;Study Physician. MARVELS. Malawi Liverpool Wellcome Programme
Outcome results
None listed