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Experimental Human Pneumococcal Challenge With SPN3

NCT05535868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-06-29

Study results available
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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
  • Controlled Human Infection

Interventions

OTHER

Serotype 3 Experimental Human Pneumococcal Challenge - Liverpool Isolate (LIV014-S3)

Dose-ranging and reproducibility study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation

OTHER

Serotype 3 Experimental Human Pneumococcal Challenge - Malawi Isolate (MLW-10V)

Dose-ranging study of SPN3 inoculation AND targeted booster inoculation at day-14, where prime inoculation fails to lead to experimental colonisation

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • University of Oxford

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    lead OTHER

Principal Investigators

  • Andrea Collins, MBChB, PhD · Senior Clinical Lecturer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-11-21
Completion
2023-11-21

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535868 on ClinicalTrials.gov