Experimental Human Pneumococcal Challenge With SPN3

NCT05535868 | Unknown DMC

• 1 other identifier: 22-003
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 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.

Conditions

Streptococcus Pneumonia

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with experimental SPN3 colonisation of the nasopharynx (assessing change from non carrier to carrier)

  change from non carrier to carrier 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.

  at any time point following one or two inoculations (combined and individually at day 0 or day 14 or both)) ie day 2,7,13,16,21 or day 28

Secondary Outcomes (18)

• The rate of occurrence of SPN3 experimental colonisation of the nasopharynx

  at any time point following one or two inoculations (combined and individually atday 0 or day 14 or both)) ie day 2,

• The rate of occurrence of SPN3 experimental colonisation of the nasopharynx

  at any time point following one or two inoculations (combined and individually at day 0 or day 14 or both)) ie day 7

• The rate of occurrence of SPN3 experimental colonisation of the nasopharynx

  at any time point following one or two inoculations (combined and individuallyat day 0 or day 14 or both) ) ie day 13

• The rate of occurrence of SPN3 experimental colonisation of the nasopharynx

  at any time point following one or two inoculations (combined and individually at day 0 or day 14 or both)) ie day 16

• The rate of occurrence of SPN3 experimental colonisation of the nasopharynx

  at any time point following one or two inoculations (combined and individually at day 0 or day 14 or both)) ie day 21

Study Arms (2)

SPN3.

EXPERIMENTAL

Inoculation with SPN3 at D0 visit. 0.1ml of pneumococcus is given

Other: SPN3 innoculation

SPN3 booster

EXPERIMENTAL

inoculation booster at day 14 This visit will only occur for participants who have tested negative for SPN3 at days 2 and 7. 0.1ml of pneumococcus is given

Other: SPN3 innoculation

Interventions

SPN3 innoculation OTHER

Healthy adult participants aged 18-50 (inclusive) will be inoculated with pure culture of well-characterised, fully sequenced amoxicillin-sensitive SPN3. They will be observed for safety and development of pneumococcal colonisation

SPN3 booster; SPN3.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

LSTM

Liverpool, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Collins, MBChB, PhD

  Senior Clinical Lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly L Davies, BSc

CONTACT

+44 151 702 9391; kelly.davies@lstmed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• 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: August 1, 2023
• Study Completion: August 31, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)