ISRCTN15728847
Completed
Phase 4
A phase IV double-blind randomised controlled trial (DBRCT) to investigate the effect of PCV-13 and PPV-23 on pneumococcal colonisation using the experimental human pneumococcal challenge (EHPC) model in healthy adults
iverpool School of Tropical Medicine0 sites516 target enrollmentJune 18, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pneumonia
- Sponsor
- iverpool School of Tropical Medicine
- Enrollment
- 516
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35798520/ (added 08/07/2022)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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