PCV13 and Pneumococcal Colonisation in Malawi
- Conditions
- Respiratory
- Registration Number
- PACTR202008503507113
- Lead Sponsor
- iverpool School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
Previous pneumococcal vaccination.
COVID-19 positive at time of screening tests
HIV-infection sero positive. HIV self-test kits will be used by participants to confirm infection status in the presence of the research team. Any seropositive participant will be referred to trained personnel certified in HIV Testing Services (HTS) for confirmatory Determine” and Unigold” tests. Any participants confirmed as HIV-infection positive will be referred to the governmental system for infection confirmation, treatment and follow up.
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.
Participant is positive for Streptococcus pneumoniae serotype 6B on nasal wash sample at visit C. Cur
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of Spn6B in nasal wash by classical microbiology
- Secondary Outcome Measures
Name Time Method Spn6B detected in nasal wash at day 2, 7 or 14 post inoculation. Carriage density by classic microbiology and PCR. Serum and nasal fluid evaluation by ELISA/multiplex and Ig functional assays. Antigen specific and non-specific cellular responses in blood and nasal cells. Participant exit interviews<br>