Evidence map›Paper›PMID 41290307›Full record

ArticleBMJ open2025

Protocol for a phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate

Bruno Rocha de Macedo, Carla Solórzano, Angela Hyder-Wright, Julia Lustosa Martinelli, Hannah Robinson, Sanjita Brito-Mutunayagam, B C Urban, Tatiana Codreanu, Filora Elterish, Elena Mitsi and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06731374 (A Phase IV, Experimental Human Pneumococcal Challenge), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06731374 phase4recruitingnot on this map

A Phase IV, Experimental Human Pneumococcal Challenge (EHPC) Model to Investigate Streptococcus Pneumoniae Serotype 3 (SPN3) Colonisation Following PCV15, a Double Blind Randomised Controlled Trial (DBRCT) in Healthy Participants Aged 18 - 50 Years in the UK.

TypeinterventionalSponsorUniversity of OxfordRan2025 to 2026Enrolled106ConditionsPneumococcal Disease, Pneumococcal CarriageArmsPCV15, Streptococcus pneumoniae serotype 3, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Bruno Rocha de MacedoDepartment of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6210-6594
Carla SolórzanoDepartment of Paediatrics, University of Oxford, Oxford, UK.
Angela Hyder-WrightDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Julia Lustosa MartinelliDepartment of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0000-8241-3826
Hannah RobinsonDepartment of Paediatrics, University of Oxford, Oxford, UK.
Sanjita Brito-MutunayagamDepartment of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0009-0008-3715-2493
B C UrbanDepartment of Paediatrics, University of Oxford, Oxford, UK.
Tatiana CodreanuDepartment of Paediatrics, University of Oxford, Oxford, UK.
Filora ElterishDepartment of Paediatrics, University of Oxford, Oxford, UK.
Elena MitsiDepartment of Paediatrics, University of Oxford, Oxford, UK.
Ashleigh HowardDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Dima El SafadiDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Kiarash TanhaDepartment of Paediatrics, University of Oxford, Oxford, UK.
Xinxue LiuDepartment of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-1107-0365
Olga MazurDepartment of Paediatrics, University of Oxford, Oxford, UK.
Maheshi N RamasamyDepartment of Paediatrics, University of Oxford, Oxford, UK.
Andrea CollinsDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
D M FerreiraDepartment of Paediatrics, University of Oxford, Oxford, UK daniela.ferreira@paediatrics.ox.ac.uk.
Simon B DrysdaleDepartment of Paediatrics, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMETHODS AND ANALYSIS: Healthy adults aged 18-50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue. ETHICS AND DISSEMINATION: This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001). TRIAL REGISTRATION NUMBER: NCT06731374 - ISRCTN91656864.

Indexed as

Carrier StatePneumococcal InfectionsPneumococcal VaccinesStreptococcus pneumoniaeAdolescentAdultDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedRandomized Controlled Trials as TopicSerogroupUnited KingdomVaccines, ConjugatePneumococcal VaccinesVaccines, ConjugateImmunologyRespiratory infectionsVaccination

Identifiers

PMID41290307
PMCPMC12645660

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.