Table 2.
Exclusion criteria
| Research participant | Currently involved in another study unless observational or non-interventional, excluding the EHPC bronchoscopy study and COVID-19 observation and interventional trials |
| Participant in any previous EHPC trial in past 1 year | |
| Previous EHPC trial inoculated with SPN3 in last 3 years | |
| Vaccination | Previous pneumococcal vaccination PPV23 or PCV13 or PCV10. |
| Allergy | Allergy to penicillin |
| Comorbidities | Chronic respiratory, cardiac, kidney, liver or neurological disease |
| Connective tissue disease | |
| Diabetes | |
| Immunosuppressive disease | |
| Recurrent otitis media | |
| Asplenia or spleen dysfunction | |
| Cochlear Implants | |
| Major cerebrospinal fluid leak | |
| Uncontrolled medical/surgical conditions (at discretion of study doctor) | |
| Major pneumococcal illness requiring hospitalisation within the last 10 years | |
| Other conditions considered by clinical team as a concern for safety/integrity of the study | |
| Significant mental health problems (uncontrolled or previous admission to psychiatric unit) | |
| Medications | Immunosuppressive medication |
| Long-term antibiotic use or use of antibiotics in 28 days prior to inoculation | |
| Direct caring role or close contact with individuals at higher risk of infection (during the EHPC period) unless wearing personal protective equipment | Children aged under 5 |
| Chronic ill health or immunosuppressed adults | |
| People that are part of extremely vulnerable group as defined by Public Health England | |
| Smoking/drug/alcohol use | Current or ex-smoker (daily cigarettes/e-cigarettes/smoking of recreational drugs) in the last 6 months. Participants who smoke<5 cigarettes per week may be included |
| Previous significant smoking history (>20 pack years) | |
| History or current drug or alcohol abuse (frequently drinking alcohol): men and women should not regularly drink>3 units/day and >2 units/day, respectively) at discretion of the clinician | |
| Biologically female participants of childbearing potential who are currently pregnant/lactating, intending on becoming pregnant or not on effective birth control | |
| Overseas travel (involving air travel) planned in follow-up period of study visits | |
Participants who meet following criteria at time of screening:
| |
EHPC, Experimental Human Pneumococcal Challenge; SPN3, Streptococcus pneumoniae serotype 3.