Challenge 3
Research type
Research Study
Full title
Serotype 3 Experimental Human Pneumococcal Challenge; Dose ranging and reproducibility in a healthy volunteer population
IRAS ID
306700
Contact name
Andrea Collins
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Streptococcus pneumoniae (SPN) is a major cause of morbidity and mortality from a lower respiratory tract infection globally, causing pneumonia, meningitis and sepsis. Since the introduction of pneumococcal conjugated vaccines, the rates of pneumococcal disease have declined for many of the serotypes of SPN covered by the vaccine. However, serotype 3 (SPN3) continues to cause significant disease. The Experimental Human Pneumococcal Challenge (EHPC) model has been developed over 10 years as a unique method of determining rates of nasal colonisation with SPN, understanding the impact of colonisation on immunity and for testing vaccines against SPN. In order to increase the relevance of the EHPC model and its use for vaccine development, we will develop an EHPC model for SPN3.
In this stay, we aim to determine the optimal dose and isolate of SPN3 to establish nasopharynx colonisation of healthy adults, using the Experimental Human Pneumococcal Challenge model.
Healthy adults aged 18-50 years of age will be recruited. A recruitment target of up to 117 participants with an approximate screen failure/dropout rate of 20% will ensure up to 93 participants complete the trial.
We will use a human challenge study to establish an SPN3 EHPC model, consisting of two parts. The first part is a dose ranging and safety study whereby sequential cohorts of 10 healthy participants are challenged with escalating doses of SPN3. Up to two isolates of SPN3 will be tested in this part of the study. Colonisation will be determined using nasal wash sampling. Using the dose and isolate that results in optimal colonisation, we will complete the cohort with another 33 participants to check for reproducibility of attack rate. In the reproducibility study, various samples will be taken for determination of both local and systemic immunological responses to pneumococcal challenge.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0051
Date of REC Opinion
7 Mar 2022
REC opinion
Favourable Opinion