NCT05361499

A Controlled Human Pneumococcal Infection Model (PIM) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia, bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although pneumococcal vaccines exist, they do not provide complete protection and new strategies to combat this pathogen are urgently needed. Asymptomatic infection of S. pneumoniae in the human nasopharynx precedes the development of pneumococcal disease. Previously, an Experimental Human Pneumococcal Carriage (EHPC) model has been developed at the Liverpool School of Tropical Medicine (LSTM). The current study entails to establish this model in healthy adults living in the Netherlands using the inoculation dose currently used at LSTM. Healthy adult participants (M/F) will be inoculated intranasally with strain BHN418, a penicillin sensitive serotype 6B strain of S. pneumoniae that was previously isolated from a healthy carrier. Following inoculation, participants will be monitored and blood and nasal samples will be collected over a period of 28 ± 3 days. Participants will receive a course of amoxicillin to eradicate infection on or shortly after the last visit at day 28 ± 3, unless S. pneumoniae is not detected on both day 14 and 28 ± 3 post-inoculation.

Conditions

• Streptococcus Pneumoniae Infection

Interventions

Type	Name	Description
BIOLOGICAL	Sp_6B	Intranasal inoculation of Streptococcus pneumoniae serotype 6B, 160,000 colony forming units (CFU)
DRUG	Amoxicillin 500 mg	Amoxicillin, 7 days, 2x 500 mg

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2022-05-04
• Last updated: 2023-02-22

Locations

1 site across 1 country: Netherlands