HIV Clinical Trial - Experimental Pneumococcal Carriage in People Living

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The EHPC has been established at the Malawi-Liverpool Wellcome centre (MLW) and demonstrated acceptability and feasibility in this setting. To date, over 250 participants have been enrolled on the EHPC at MLW without any study complications. Participants will be inoculated in both nostrils with a controlled concentration of penicillin-sensitive Streptococcus pneumoniae. Participants will be followed up for 25 days following inoculation during which sampling will occur at established time-points to establish pneumococcal carriage and immune cell/immunoglobulin dynamics. After 21 days, participants who demonstrate pneumococcal carriage will commence an antibiotic course to clear the bacteria (participants may be advised by the clinical study team to commence antibiotics earlier if they develop any symptoms of pneumococcal disease). Participants will remain under close observation in study accommodation for the first 3 days following inoculation, and will then be monitored daily at home via text message and telephone calls. A final health-check and exit interview will be conducted on day 25 to evaluate participant satisfaction with study participation. The overall objective is to characterise rates and determinants of experimental pneumococcal carriage in PLHIV in Blantyre, Malawi in order to inform vaccine evaluations and vaccine policy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05698225
Study type	Interventional
Source	Liverpool School of Tropical Medicine
Contact	Klara Doherty, MBChB
Phone	+265885908115
Email	klara.doherty@lstmed.ac.uk
Status	Not yet recruiting
Phase	N/A
Start date	January 2023
Completion date	January 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Experimental Pneumococcal Carriage in People Living With HIV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms