Pneumococcal disease MedDRA version: 15.1 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 15.1 Level: PT Classification code 10063430 Term: Hepatitis A immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Prevenar 13
Product Name: Prevenar 13
Product Code: EU/1/09/590/001
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 1
Concentration
Sponsors
Royal Liverpool University Hospital
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 yrs old (chosen to minimise the risk of pneumococcal infection post inoculation) 2. Fluent English spoken (to ensure a comprehensive understanding of the research project and their involvement - this is predominately for safety reasons). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Previously received PPV or any PCV vaccines (at any age) – full vaccine history obtained from General Practitioner as necessary • Previously lived in a hepatitis A endemic area • Previously received a complete course of hepatitis A vaccination • Previous significant adverse reaction to any vaccination/immunisation • Close contact with at risk individuals (children, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission • Current smoker or significant smoking history (>10 pack yrs) – to minimise risk of pneumococcal infection and optional bronchoscopy • Asthma (on regular medication) or respiratory disease – to minimise risk of bronchoscopy or pneumococcal infection • Pregnancy – to minimise risk of pneumococcal infection and no safety data exists for either vaccine in pregnancy • Breast-feeding mothers - no safety data exists for either vaccine in pregnancy • Women of child-bearing potential (WOCBP) who are deemed not to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination • Allergic to penicillin/amoxicillin • Involved in another clinical trial unless observational or in follow-up (non-interventional) phase • Previously been involved in a clinical trial involving experimental human pneumococcal carriage • Unable to give fully informed consent • Medication that may affect the immune system (e.g. steroids, steroid nasal spray) • Current acute severe febrile illness at the time of vaccination/inoculation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study aim is to determine whether PCV is protective against pneumococcal carriage in healthy adult volunteers.;Secondary Objective: The secondary aims are to examine the local and systemic innate, humoral and cellular immune responses to PCV +/- pneumococcal nasal carriage.;Primary end point(s): The primary endpoint is PCV-induced protection against pneumococcal carriage. Classical culture methods (and PCR techniques) will be used to detect the presence, density and duration of pneumococcal carriage in nasal wash post inoculation.;Timepoint(s) of evaluation of this end point: An interim analysis is planned after the first 50 volunteers have completed the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Important secondary endpoints including the immune responses, in particular humoral and cellular responses, will also be assessed.;Timepoint(s) of evaluation of this end point: An interim analysis is planned after the first 50 volunteers have completed the study. | — |
Countries
United Kingdom
Outcome results
None listed