At a glance
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Serotype 3 Experimental Human Pneumococcal Challenge; Dose Ranging and Reproducibility in a Healthy Volunteer Population
In Brief
A clinical study evaluating Serotype 3 Experimental Human Pneumococcal Challenge - Liverpool Isolate (LIV014-S3) and Serotype 3 Experimental Human Pneumococcal Challenge - Malawi Isolate (MLW-10V) for Streptococcus Pneumonia and Controlled Human Infection. Completed, enrolled 91 participants across 1 site.
Signals
Detailed Summary
The 'Experimental Human Pneumococcal challenge' (EHPC) model is a way of putting drops of bacteria into the nose. Investigators have studied this model of putting bacteria in the nose safely in over 1500 volunteers over the past decade with no serious side effects and now want to test the model using a different strain of the bacteria that is commonly found in the community, SPN3. The aim of this study is to determine how much pneumococcus is needed to achieve nasal colonisation and how long the bacteria live in the nose for before natural immune responses eradicate them. By doing this, Investigators will then be able to test how well future vaccines prevent colonisation with pneumococcus. Investigators want to learn more about how the immune system responds to nasal colonisation with pneumococcus, again to help with development of new vaccines.
Study Details
Timeline
Arms & Interventions
Malawi isolate, low dose
Malawi isolate, intermediate dose
Malawi isolate, higher dose
Liverpool isolate, low dose
Liverpool isolate, intermediate dose
Liverpool isolate, higher dose (includes dose-ranging and reproducibility study participants, since the reproducibility study only included this isolate and dose)
Interventions
Dose-ranging and reproducibility study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation
Dose-ranging study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation