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New treatment option for Pneumococcal Disease
Official title Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15
ClinicalTrials.gov ID: NCT06731374
What this study is testing
What is PCV15?
PCV15 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pneumococcal disease.
Also referred to as VAXNEUVANCE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Streptococcus pneumoniae (pneumococcus) is a bacterium that causes just under four million serious infections every year. It is normal for pneumococcus bacteria to live in the noses of healthy adults and children as part of the nasal microflora without causing harm.
- Phase 4: studies an already-approved treatment
- Time commitment: about 2 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Adults between 18 to 50 years old (inclusive) at the time of enrolment.
- Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant...
- Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement.
- Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diary after...
- Willing and able to give informed consent for participation in the study.
You likely can't join if
- Research Participants:
- Participation in another research study, in which procedures performed could compromise the integrity of this study (such as significant volumes of...
- Currently a participant in a previous EHPC trial within the last 2 years or at the discretion of the study team
- Vaccination (self-reported or confirmed from GP questionnaire or medical records/summary if deemed necessary at clinician discretion):
- Have had any previous pneumococcal vaccination in the past 5 years (including in a research study)
- Planned vaccination during the study
See the full eligibility criteria
Who can join
- Adults between 18 to 50 years old (inclusive) at the time of enrolment.
- Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through to the...
- Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement.
- Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diary after inoculation.
- Willing and able to give informed consent for participation in the study.
- Willing to allow confirmation of past medical history either through provision of, or access to, a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical...
- Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study.
- Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS).
- For participants of childbearing potential only: willing to use effective contraception for the duration of the study AND to have a pregnancy test on the day of screening and challenge.
What rules you out
- Research Participants:
- Participation in another research study, in which procedures performed could compromise the integrity of this study (such as significant volumes of blood taken), or are planning to do so within the trial period
- Currently a participant in a previous EHPC trial within the last 2 years or at the discretion of the study team
- Vaccination (self-reported or confirmed from GP questionnaire or medical records/summary if deemed necessary at clinician discretion):
- Have had any previous pneumococcal vaccination in the past 5 years (including in a research study)
- Planned vaccination during the study
- Allergy:
- Have an allergy to penicillin or amoxicillin (for main study cohort only)
- History of a bleeding disorder (e.g., Factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- Have previous anaphylaxis or severe adverse reaction to any component/excipient of the vaccine or to any vaccine
- Allergy to Lidocaine local anaesthetic (for nasal biopsy cohort only)
- Health History (self-reported or confirmed from GP questionnaire or medical records/summary if deemed necessary): moderate ill health including but not limited to:
- Asplenia or dysfuction of the spleen
- Chronic respiratory disease (e.g. asthma [on medication], COPD, emphysema, bronchiectasis)
- Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) [controlled stable hypertension +/- angina may be included].
- Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, on dialysis)
- Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis)
- Chronic neurological conditions
- Connective tissue disease
- Dementia
- Diabetes mellitus (including diet controlled)
- Immunosuppression or history of receiving immunosuppressive therapy - at the discretion of the investigator
- Individuals with cochlear implants
- Individuals with major cerebrospinal fluid leaks (e.g. following trauma, major skull surgery, or requiring CSF shunt)
- Recurrent otitis media.
- History of significant unexplained bleeding after a surgical or dental procedure (for nasal biopsy participants only)
- Have any uncontrolled medical/surgical/mental health conditions at the discretion of the study doctor.
- Major pneumococcal illness requiring hospitalisation within the last 10 years.
- Significant mental health condition (e.g previous admissions in a psychiatric unit, at the discretion of the clinician) that would impair the participant's ability to participate in the study
- Taking Medications:
- Any medication that may affect the immune system in the last 3 months (e.g. systemic steroids [IM/IV], Roaccutane, disease modifying anti-rheumatoid drugs)
- Long-term use of antibiotics (see also section of Temporary Exclusion Criteria)
- Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 1 month
- Use of any medication affecting blood clotting (any oral/injectable anticoagulants)
- Female participants who are pregnant, lactating or intending on becoming pregnant during the study
- Direct caring role or close contact with individuals at higher risk of infection (for main study cohort only):
- Children under 5 years of age
- Chronic ill health or immunosuppressed adults
- Older adults
- Smoker:
- Current or ex-smoker (regular cigarettes/cigars/e-cigarette/vaping/smoking of recreational drugs) in the last 6 months
- Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [\>20 pack years])
- Suspected or known current alcohol or drug abuse, as per investigators discretion
- Overseas travel during the follow-up period (from the time point of inoculation to antibiotic treatment or completion of the 28 day follow up period post inoculation)
- Any other issue which, in the opinion of the study staff, may:
- Put the participant or their contacts at risk because of participation in the study
- Adversely affect the interpretation of the study results, or
- Impair the participant's ability to participate in the study
- Study site staff or a partner or dependent child of study site staff
The study team makes the final eligibility decision.
Where it's taking place
- Liverpool, North West, United Kingdom
- Oxford, Oxfordshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liverpool, North West, United Kingdom; Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.