Experimental Human Pneumococcal Challenge With SPN3 (Challenge3)

This is an interventional prevention trial for Streptococcus Pneumonia Read More

Inclusion Criteria:• Healthy young adults aged 18-50 years (inclusive). This age range minimises the risk of invasive pneumococcal infection and allows comparison with previously published experimental work done by our group.

• Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement, enabling valid consent to be given.
• Access to their own mobile telephone - to ensure safety and timely communication.
• Capacity to give informed consent.

Exclusion Criteria:

• o Currently involved in another study unless observational or non-interventional, excluding the EHPC bronchoscopy study (at the discretion of the study team). This is to ensure no harm comes to the participants through over-sampling.

  • Participant in any previous EHPC trial in past year
  • Participant in previous EHPC trial inoculated with SPN3 in the last 3 years

  • Participant in EHPC Pneumo 2 trial

    • Vaccination: Previous pneumococcal vaccination PPV23 or PCV13 (routine in babies born in the UK since 2005) or PCV10. This can be self-reported or confirmed from GP questionnaire (GPQ) if deemed necessary at clinician discretion.
    • Allergy: to penicillin/amoxicillin
    • Health history (self-reported or confirmed by GPQ or medical summary if felt to be necessary at clinician discretion):
  • Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease.
  • Medication that may affect the immune system e.g., steroids, inflammation altering or disease-modifying anti-rheumatoid drugs.
  • Long term use of antibiotics for chronic infection.
  • Major pneumococcal illness requiring hospitalisation in the last 10 years.
  • Other conditions considered by the clinical team as a concern for participant safety or integrity of the study

  • Significant mental health problems (uncontrolled condition or requiring previous admission to a psychiatric unit) that would impair ability to participate

    • Direct caring role or close contact with individuals at higher risk of infection during the inoculation period if personal protective equipment (PPE) not worn:

  • Children under 5 years age
  • Adults with chronic ill health or immunosuppression

  • Hospital patients

    • Smoker:

  • Current or ex-smoker (daily cigarettes, daily e-cigarettes/vaping and daily smoking of recreational drugs) in the last 6 months. Participants who smoke <5 cigarettes per week may be included.

  • Previous significant smoking history (>20 cigarettes per day for 20 years or equivalent [>20 pack years]).

    • Biologically female participants of child-bearing potential (WOCBP) who are:

  • Currently pregnant/lactating
  • Intending on becoming pregnant during the study

  • Not deemed to have effective birth control

    • History of or current drug or alcohol abuse:

  • Men should not drink >3 units/day regularly

  • Women should not drink >2 units/day regularly

    • Overseas travel planned in follow up period of study visits
    • Natural SPN 3 colonisation in baseline nasal wash - if a participant is colonised with non-SPN3 pneumococcus, they can be included as part of exploratory analyses, but would not be included in the primary analysis
    • STOP criteria - participants who meet STOP criteria at time of screening (Table 3) 6.3 Temporary Exclusion Criteria
    • Ongoing COVID-19 symptoms (fever, cough, shortness of breath, anosmia or ageusia) or confirmed current COVID-19 infection. Participants with resolved COVID-19 after their UKHSA determined isolation period has ended can be included.
    • Current/acute illness within 14 days prior to inoculation if COVID-19 negative
    • Positive COVID-19 swab whether symptomatic or asymptomatic within 10 days of inoculation
    • Currently isolating following exposure to COVID-19 as per UKHSA guidance
    • Antibiotic use within 28 days of inoculation.
    • Participants who have been temporarily excluded at screening may be re-screened at a later date to assess their eligibility at this time for inclusion into the study. At this point, the participant would be re-consented if their initial written consent was given >4 months prior to this date.
    • Vaccination 21 days prior to inoculation