A Controlled Human Pneumococcal Infection Model (PIM) Study (NCT05361499) | Clinical Trial Compass
CompletedNot Applicable
A Controlled Human Pneumococcal Infection Model (PIM) Study
Netherlands20 participantsStarted 2022-05-31
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is aged ≥ 18 and \< 50 years on the day of the baseline visit.
. Participant is in good health as confirmed by review of medical history and physical examination.
. Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
. Participant has a home address within the Netherlands.
. Participant is fully conversant in the Dutch language
. Participant is able to communicate easily by both mobile telephone and text messaging
. Participant is available to attend all study visits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of volunteers infected with S. pneumoniae serotype 6B following inoculation.
. Participant agrees to inform his/her general practitioner (GP), in case applicable, about participation in the study and signs a request to release any relevant medical information concerning possible contra-indications for participation in the study by the GP.
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: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
. Previous pneumococcal vaccination or infection with the pneumococcus at screening or inclusion visit
. Close physical contact with at risk individuals, i.e. children under 5 years of age, immunosuppressed adults, frail elderly, chronically ill individuals. Close physical contact is defined as:
. Illness at screening visit, illness at baseline (including mild upper respiratory tract infection, common cold, running nose), acute illness within 3 days prior to inoculation
. Any antibiotic treatment within 2 weeks before inoculation
. For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study.
. Known hypersensitivity to or contra-indications (including co-medication) for use of penicillin