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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Intranasal inoculation of Streptococcus pneumoniae serotype 6B, 160,000 colony forming units (CFU)
Amoxicillin, 7 days, 2x 500 mg
Radboudumc
Nijmegen, Netherlands
Percentage of volunteers infected with S. pneumoniae serotype 6B following inoculation.
Time frame: up to 4 weeks after inoculation
The number of participants with sollicited AEs that are related to infection
Time frame: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
The number, type and severity of sollicited AEs that are related to infection
Time frame: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
Number of sampling timepoints with S. pneumoniae culture-positive nasal wash samples post-inoculation
Time frame: On day 3, 7, 14 and 28 after inoculation
Number of colony forming units (CFUs) per ml detected in nasal wash of infected participants at each sampling timepoint
Time frame: On day 3, 7, 14 and 28 after inoculation
Concentrations of S. pneumoniae-specific antibodies in blood and mucosal samples at the various sampling time points
Time frame: On day 3, 7, 14 and 28 after inoculation
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