PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2) (Pneumo 2)

This is an interventional prevention trial for Streptococcus Pneumonia Read More

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.