NCT05698225

Experimental Pneumococcal Carriage in People Living With HIV

Characterising Pneumococcal Carriage and Immunity in People Living With HIV in Blantyre, Malawi, Following Experimental Pneumococcal Inoculation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pneumococcus; Pneumonia
• Hiv

Interventions

Type	Name	Description
OTHER	Streptococcus pneumoniae serotype 6B	A controlled concentration of streptococcus pneumoniae serotype 6B is placed in both nares of participants

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: Malawi