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Nose drops of pneumonia bacteria could pave way for better vaccines

NCT ID NCT05535868

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study investigates how a specific strain of pneumococcus bacteria (serotype 3) colonizes the nose of healthy adults. Researchers will give volunteers nose drops containing the bacteria to see what dose leads to colonization and how long the bacteria stay before the immune system clears them. The goal is to develop a reliable model for testing future vaccines against pneumococcal infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Serotype 3 pneumococcal bacteria (nose drops)
What this could lead to
If successful, this model could help researchers test new vaccines that prevent pneumococcal infections more effectively.
What could go wrong
This is an early-stage model study, not a treatment trial. It may not translate into real-world vaccine success, and some participants may experience temporary nasal colonization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

91 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:• Healthy young adults aged 18-50 years (inclusive). This age range minimises the risk of invasive pneumococcal infection and allows comparison with previously published experimental work done by our group. * 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. Exclusion Criteria: * 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 * Adults with chronic ill health or immunosuppression * Hospital patients • Smoker: * Current or ex-smoker (daily cigarettes, daily e-cigarettes/vaping and daily smoking of recreational drugs) in the last 6 months. Participants who smoke \<5 cigarettes per week may be included. * Previous significant smoking history (\>20 cigarettes per day for 20 years or equivalent \[\>20 pack years\]). • Biologically female participants of child-bearing potential (WOCBP) who are: * Currently pregnant/lactating * Intending on becoming pregnant during the study * Not deemed to have effective birth control • History of or current drug or alcohol abuse: * Men should not drink \>3 units/day regularly * Women should not drink \>2 units/day regularly * Overseas travel planned in follow up period of study visits * Natural SPN 3 colonisation in baseline nasal wash - if a participant is colonised with non-SPN3 pneumococcus, they can be included as part of exploratory analyses, but would not be included in the primary analysis * STOP criteria - participants who meet STOP criteria at time of screening (Table 3) 6.3 Temporary Exclusion Criteria * Ongoing COVID-19 symptoms (fever, cough, shortness of breath, anosmia or ageusia) or confirmed current COVID-19 infection. Participants with resolved COVID-19 after their UKHSA determined isolation period has ended can be included. * Current/acute illness within 14 days prior to inoculation if COVID-19 negative * Positive COVID-19 swab whether symptomatic or asymptomatic within 10 days of inoculation * Currently isolating following exposure to COVID-19 as per UKHSA guidance * Antibiotic use within 28 days of inoculation. * Participants who have been temporarily excluded at screening may be re-screened at a later date to assess their eligibility at this time for inclusion into the study. At this point, the participant would be re-consented if their initial written consent was given \>4 months prior to this date. * Vaccination 21 days prior to inoculation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Liverpool School of Tropical Medicine

    Liverpool, L7 8XZ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.