Serotype 3 Experimental Human Pneumococcal Challenge; Dose Ranging and Reproducibility in a Healthy Volunteer Population (Challenge3)

  • STATUS
    Recruiting
  • days left to enroll
    84
  • participants needed
    117
  • sponsor
    Liverpool School of Tropical Medicine
Updated on 18 October 2022
Accepts healthy volunteers

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.

Description

In this study, investigators propose to determine the optimal dose and isolate of SPN3 to establish colonisation in the human nasopharynx, as well as improving knowledge of immune responses to SPN3 colonisation. The results from this study will be used to inform development of improved SPN3 vaccines and to inform design of future pneumococcal vaccine RCTs.

To increase the relevance of the EHPC model and its use for assessing future vaccines such as V114, investigators are proposing here to set up an EHPC model with carefully selected non-proprietary SPN3 strains. Investigators will conduct a safety and dose-ranging study to determine the optimum SPN3 strain and dose for colonisation acquisition and confirm the dose in a subsequent larger cohort in a reproducibility study and will study mucosal and systemic immune responses to this serotype and their association with protection against colonisation acquisition and clearance.

Details
Condition Streptococcus Pneumonia
Treatment SPN3 innoculation
Clinical Study IdentifierNCT05535868
SponsorLiverpool School of Tropical Medicine
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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