A controlled human pneumococcal infection model

Completed

Conditions: nasal carriage of Streptococcus pneumoniae
pneumococcal infection
10004018

Registration Number: NL-OMON51807

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Participant is:
- Aged >= 18 and < 50 years on the day of screening.
- In good health as confirmed by review of medical history and physical
examination.
- Able to arrive within 3h at the Radboudumc at any time during the study
participation, and participant is able to arrive within 1h at the Radboudumc
from his/her home address.
- Willing to take a curative antibiotic course after inoculation with S.
pneumoniae, according to the study protocol.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>- Percentage of volunteers infected with S. pneumoniae</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- The number of solicited (S)AEs from baseline visit (day -1 to -6) till the<br /><br>end of the study (day 28±3)<br /><br>- Number of colony forming units detected in nasal wash of infected<br /><br>participants at various samples timepoints<br /><br>- Concentrations of S. pneumoniae-specific IgM, IgG and IgA in serum and<br /><br>mucosal lining fluid at the various sampling time points </p><br>