Pneumonia Respiratory Pneumonia
Conditions
Interventions
The PPV-23 vaccine is a 23-valent pneumococcal polysaccharide vaccine produced by Merck Sharp & Dohme Limited. It has marketing authorisation and is licensed for activate immunisation against pneumoco
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/04/2022: 1. Aged 18 to 50 years 2. Speak English fluently (to ensure a comprehensive understanding of the research project and proposed involvement) 3. Have the capacity to give informed consent 4. Have a urine pregnancy test and agree to use adequate contraception during the study (if able to bear children) _____ Previous inclusion criteria: 1. Aged 60 to 69 years 2. Speak English fluently (to ensure a comprehensive understanding of the research project and proposed involvement) 3. Have the capacity to give informed consent 4. Have a urine pregnancy test and agree to use adequate contraception during the study (if able to bear children)
Exclusion criteria
Exclusion criteria: 1. Currently involved in another research study (unless observational or non-interventional) 2. Involved in a previous EHPC study in the last 3 years involving exposure to pneumococcus 3. Previously received a pneumococcal vaccination 4. Allergy to penicillin or amoxicillin 5. Have had a severe, life-threatening allergic reaction to a vaccine 6. Chronic ill-health, including but not limited to problems with the immune system, diabetes, asthma requiring regular medication, recurring ear infections, COPD, major heart/lung disease, cancer, and rheumatoid arthritis 7. Taking medication that may affect the immune system, including but not limited to steroids, nasal steroids, Roaccutane, and anti-rheumatoid drugs 7. Recent antibiotics, either within the last 28 days or long-term for a chronic infection 8. Pneumococcal illness requiring a stay in a hospital within the last 10 years 9. Any other condition that is deemed to possibly put personal safety or the study at risk as decided by the clinical team 10. Employed in a direct caring role or close contact with individuals at higher risk of infection on a regular basis during the study, including but not limited to children under 5, and people with chronic ill-health or immunosuppression 11. Current smoker, or ex-smoker who has quit within the last 6 months, of regular cigarettes, cigars, e-cigarettes, vapes, and/or recreational drugs 12. Previous significant smoking history of >20 pack-years (20 cigarettes per day for 20 years or equivalent) 13. Pregnant, lactating or intending on becoming pregnant during the study 14. History or current drug or alcohol abuse as assessed by the clinical team 15. Overseas travel planned during the exposure stages of the study which is defined as the time of inoculation until the use of antibiotics 16. Natural pneumococcal carriage. It is anticipated that 10-15% of participants will have a natural pneumococcal carriage at the time of recruitment. Testing will be repeated a few weeks after the initial screening appointment to check if carrier status has changed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of experimental pneumococcal colonization (SPN6B) determined by the presence of pneumococcus in nasal wash (NW) by classical culture at any time point following pneumococcal challenge (7-month challenge, Day 2 to Day 22) at 7, 23, 30, 35, 42, 50, 191, 203, 210 and 218 days following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Experimental pneumococcal colonization (SPN3) determined by the presence of pneumococcus in nasal wash (NW) by classical culture and throat, saliva, urine, and blood samples at any time point following pneumococcal challenge (1-month challenge, Day 2 to Day 22) at 7, 23, 30, 35, 42, 50, 191, 203, 210 and 218 days following vaccination 2. Experimental SPN3 in one or more ‘friends and family’ saliva samples at any time point following study participant inoculation requested at a single timepoint if the participant becomes carriage positive | — |
Countries
England, United Kingdom
Contacts
Public ContactKelly Davies
Outcome results
None listed