nasal carriage of Streptococcus pneumoniae
Conditions
Interventions
Participants will be inoculated intranasally with strain BHN418, a penicillin
sensitive serotype 6B strain of S. pneumoniae that was previously isolated from
a healthy carrier and characterized by B
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Participant is: - Aged >= 18 and
Exclusion criteria
Exclusion criteria: - Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. - Smoking - Previous pneumococcal vaccination or infection with the pneumococcus at screening or inclusion visit - Close physical contact with at risk individuals (>15 min within 1.5m distance) - For female participants: pregnancy, lactation or intention to become pregnant during the study. - Known hypersensitivity to or contra-indications (including co-medication) for use of penicillin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: - Percentage of volunteers infected with S. pneumoniae | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - The number of solicited (S)AEs from baseline visit (day -1 to -6) till the end of the study (day 28±3) - Number of colony forming units detected in nasal wash of infected participants at various samples timepoints - Concentrations of S. pneumoniae-specific IgM, IgG and IgA in serum and mucosal lining fluid at the various sampling time points | — |
Countries
Netherlands
Outcome results
None listed