Experimental Human Pneumococcal Challenge With SPN3
Challenge3
Serotype 3 Experimental Human Pneumococcal Challenge; Dose Ranging and Reproducibility in a Healthy Volunteer Population
1 other identifier
interventional
91
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2023
CompletedResults Posted
Study results publicly available
June 29, 2026
CompletedJune 29, 2026
June 1, 2026
1.3 years
April 14, 2022
February 24, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Determine the Optimal SPN3 Dose and Isolate to Establish Colonisation of the Nasopharynx in Healthy Adults
The proportion of participants with experimental SPN3 colonisation of the nasopharynx, determined by SPN3 presence in classical microbiological culture in at least one nasal wash (NW) sample, at any time point following one or two inoculations (combined and individually). This will be assessed for each isolate and dose separately.
From inoculation (day 0) to the final visit for each participant (28 days post-inoculation)
Secondary Outcomes (2)
To Determine the Density of Experimental SPN3 Colonisation of the Nasopharynx.
From inoculation (day 0) to the final visit for each participant (28 days post-inoculation)
To Determine the Duration of Experimental SPN3 Colonisation of the Nasopharynx.
From inoculation (day 0) to the final visit for each participant (28 days post-inoculation)
Study Arms (6)
MLW-10V, 10000 CFU/ml
EXPERIMENTALMalawi isolate, low dose
MLW-10V, 20000 CFU/ml
EXPERIMENTALMalawi isolate, intermediate dose
MLW-10V, 80000 CFU/ml
EXPERIMENTALMalawi isolate, higher dose
LIV014-S3, 10000 CFU/ml
EXPERIMENTALLiverpool isolate, low dose
LIV014-S3, 20000 CFU/ml
EXPERIMENTALLiverpool isolate, intermediate dose
LIV014-S3, 80000 CFU/ml
EXPERIMENTALLiverpool isolate, higher dose (includes dose-ranging and reproducibility study participants, since the reproducibility study only included this isolate and dose)
Interventions
Dose-ranging study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation
Dose-ranging and reproducibility study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool School of Tropical Medicinelead
- Malawi-Liverpool-Wellcome Trust Clinical Research Programmecollaborator
- Liverpool University Hospitals NHS Foundation Trustcollaborator
- University of Oxfordcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Liverpool School of Tropical Medicine
Liverpool, L7 8XZ, United Kingdom
Related Publications (1)
Hazenberg P, Robinson RE, Farrar M, Solorzano C, Hyder-Wright A, Liatsikos K, Brunning J, Fleet H, Bettam A, Howard A, Kenny-Nyazika T, Urban B, Mitsi E, El Safadi D, Davies K, Lesosky M, Gordon SB, Ferreira DM, Collins AM. Serotype 3 Experimental Human Pneumococcal Challenge (EHPC) study protocol: dose ranging and reproducibility in a healthy volunteer population (challenge 3). BMJ Open. 2024 Jan 10;14(1):e075948. doi: 10.1136/bmjopen-2023-075948.
PMID: 38199622BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was conducted in a healthy UK volunteer populatio (so potentially less translatable to those with chronic illnesses or of different ages or from different countries), used one serotype and two isolates only. Data collected for a few e-diary symptoms carried a high degree of subjectivity, such as trouble concentrating; these will be reconsidered in future studies.
Results Point of Contact
- Title
- Dr Andrea Collins ( Chief Investigator)
- Organization
- Liverpool School of Tropical Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Collins, MBChB, PhD
Senior Clinical Lecturer
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2022
First Posted
September 10, 2022
Study Start
August 1, 2022
Primary Completion
November 21, 2023
Study Completion
November 21, 2023
Last Updated
June 29, 2026
Results First Posted
June 29, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share