PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2) (Pneumo 2)
Streptococcus Pneumonia
About this trial
This is an interventional prevention trial for Streptococcus Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 18-50 years (inclusive)
- Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- Capacity to provide written informed consent
- Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
Exclusion Criteria:
- Be currently involved in another study unless observational or non-interventional. Exceptions are the EHPC bronchoscopy study and COVID-19 observational and interventional trials. The exceptions will be applied at the discretion of the Chief Investigator to ensure no harm comes to the participants (e.g. excessive blood sampling)
Be a participant in a previous EHPC trial within the last 3 years (at the discretion of the study team).
- Vaccination (self-reported or confirmed from GP questionnaire [GPQ] or medical summary if deemed necessary at clinician discretion): Have had any previous pneumococcal vaccination (including in a research study).
- Allergy:
- Have allergy to penicillin or amoxicillin.
Have previous anaphylaxis or severe adverse reaction to any component/excipient of the vaccines or to any vaccine.
• Health history (self-reported by the participant or confirmed in GPQ or medical summary if deemed necessary at clinician discretion): Ill health including but not limited to:
- Asplenia or dysfunction 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 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.
- Individuals with cochlear implants.
- Individuals with major cerebrospinal fluid leaks (e.g. following trauma, major skull surgery, or requiring CSF shunt).
Recurrent otitis media.
- Have any uncontrolled medical/surgical conditions (such as but not restricted to mental health conditions, epilepsy, narcolepsy or chronic pain) at the discretion of the study doctor.
- Major pneumococcal illness requiring hospitalisation within the last 10 years
- Other conditions considered by the clinical team as a concern for participant safety or integrity of the study.
- Taking medication:
- That may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, Roaccutane) or disease-modifying anti-rheumatoid drugs.
- Long-term use of antibiotics (see also section 6.3 Temporary exclusion criteria).
- Nitroglycerin
That affects blood clotting (any oral/injectable anticoagulants [except aspirin]).
- 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 (during the challenge period)
- Children under 5 years age.
- Chronic ill health or immunosuppressed adults.
People that are part of the extremely vulnerable group as defined by Public Health England (PHE)
• 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]).
- History or current drug or alcohol abuse (frequently drinking alcohol): men and women should not regularly drink >3 units/day and >2 units/day respectively) at discretion of the clinician.
- Significant mental health problems (uncontrolled condition or previous admission in a psychiatric unit, at the discretion of the clinician) that would impair the participant's ability to participate in the study
- Overseas travel planned: Overseas travel during the follow-up period Part A or Part B.
- Participants who meet STOP criteria at the time of screening, as detailed in Table 4.
- 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.
Sites / Locations
- Liverpool School of Tropical MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
PPV23
PCV13
Saline placebo