Respiratory
Conditions
Interventions
Placebo
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults aged 18-40 years - ages chosen to minimise the risk of pneumococcal infection • Fluent spoken and written Chichewa or English - to ensure a comprehensive understanding of the research project, their proposed involvement and communication with all members of the research team • Access to refrigerator or able to come to clinic daily to take dose of drug at study site
Exclusion criteria
Exclusion criteria: • Previous pneumococcal vaccination/Immunotherapy or involvement in pneumococcal controlled human infection studies (inoculation with bacteria may confer immunity) • HIV-infection seropositive. HIV self-test kits will be used by participants to confirm infection status in the presence of the research team. • Close physical contact (e.g. sleeping in the same room or nursing) with at-risk individuals (children under 5 years age, immunosuppressed adults, elderly, chronic ill health) • Allergy to penicillin/amoxicillin • Acute illness (Current illness, Acute illness within 3 days prior to inoculation, Antibiotic treatment within 2 weeks of inoculation) • Chronic illness that may impair immune response or impair ability to comply with study procedures and safety monitoring (e.g. HIV, diabetes) • Taking immunosuppressive medication that may include but is not limited to steroids and steroid nasal spray. • Pregnancy - minimise risk of pneumococcal disease • Involved in another clinical trial unless observational or in follow-up (non-interventional) phase • History of drug or alcohol abuse. This is very difficult to ascertain in a history therefore we will exclude people reporting drinking alcohol more than twice per week. • History of Smoking (Current regular smoker, smokes daily/ smokes > 5 cigarettes per week - minimise risk of pneumococcal disease. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease) • Unable to give informed consent • In case of any uncertainty or concern, the PI will take clinical responsibility for the decision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil count and T cell lymphocytes measurement in the nasal mucosa after 14 days of MV130 treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pneumococcal carriage density and duration will also be measured. Innate, humoral, and cellular responses to pneumococcal colonisation will be assessed by immunological assays on collected samples. These data will allow us to define the host variables that predict colonisation and protection due to MV130 administration.;Perceptions of and concerns about controlled human infection; experience of engagement activities and consent processes; and participant recommendations for future research. | — |
Countries
Malawi
Contacts
Public ContactNeema Toto
Project Coordinator
Outcome results
None listed