UnknownNot Applicable

Experimental Pneumococcal Carriage in People Living With HIV

Malawi150 participantsStarted 2023-01

Plain-language summary

The goal of this experimental pneumococcal carriage study is to to characterise rates and determinants of experimental pneumococcal carriage in PLHIV. The main questions it aims to answer are: * can PLHIV be experimentally inoculated with pneumococcus in a safe manner? * what are the immunological determinants of pneumococcal carriage in PLHIV compared to HIV-negative participants? * how do the pneumococcal carriage dynamics differ between PLHIV and HIV-negative participants? Participants will be inoculated intranasally with a controlled concentration of pneumococcus after which they will be monitored for 21 days during which nasal and systemic immune dynamics and pneumococcal carriage dynamics will be evaluated. At the end of the study any participants exhibiting carriage will have the pneumococcus cleared with antibiotics.

Who can participate

Age range

25 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 25 to 45 years old * Fluent spoken and written Chichewa or English * Able to give informed written consent * Access to a functional mobile phone * Establish on antiretroviral therapy for ≥2 years (if PLHIV) * Viral load below the lower limit of detection (\<LDL) at screening (if PLHIV) * CD4 count over 350 cells/mm³ at screening (if PLHIV) Exclusion Criteria: * HIV-associated hospitalisation and/or treatment for major illness in preceding 2 years * Currently under investigation for HIV-associated weight-loss, chronic diarrhoea, chronic cough, or another unexplained symptom * Previous illness caused by pneumococcus * Additional condition or medication impairing immune response or increasing risk of pneumococcal disease * Living in close contact with an individual vulnerable to pneumococcal disease * Allergy to penicillin * Acute illness in 7 days preceding inoculation * Antibiotic course in last 2 weeks (excluding prophylactic co-trimoxazole in PLHIV) * Pregnant or trying to conceive * Involved in another clinical study (unless observational or in follow-up) * Current regular cigarette smoking (5+ cigarettes per week) * Natural carrier of pneumococcus serotype 6B at screening visit * Participants without a guardian

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants with pneumococcal carriage in the nasopharynx post-inoculation

Timeframe: From inoculation up to 21 days post-inoculation

Trial details

NCT IDNCT05698225

SponsorLiverpool School of Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

Klara Doherty, MBChB

+265885908115 klara.doherty@lstmed.ac.uk

View on ClinicalTrials.gov More Pneumococcus; Pneumonia trials