Does the current pneumococcal vaccine prevent experimental nasal carriage with pneumococcal bacteria?

Not Applicable

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN45340436
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)

Brief Summary

2014 results in: T4 Pneumococcal Conjugate Vaccine Reduces Rate, Density And Duration Of Experimental Human Pneumococcal Colonisation: First Human Challenge Testing Of A Pneumococcal Vaccine. Thorax 2014;69:A2 doi:10.1136/thoraxjnl-2014-206260.4 2021 results in https://pubmed.ncbi.nlm.nih.gov/34159375/ (added 24/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Study Completion: 2014-08-13
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adults, male and female aged 18-50 years 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).

Exclusion Criteria

1. Previously received PPV or any PCV vaccines (at any age) ? full vaccine history obtained from General Practitioner as necessary
2. Previously lived in a hepatitis A endemic area
3. Previously received a complete course of hepatitis A vaccination
4. Previous significant adverse reaction to any vaccination/immunisation
5. Close contact with at risk individuals (children, immunosuppressed adults, elderly, chronic ill health) ? to minimise risk of pneumococcal transmission
6. Current smoker or significant smoking history (>10 pack yrs) ? to minimise risk of pneumococcal infection and optional bronchoscopy
7. Asthma (on regular medication) or respiratory disease ? to minimise risk of bronchoscopy or pneumococcal infection
8. Pregnancy ? to minimise risk of pneumococcal infection and no safety data exists for either vaccine in pregnancy
9. Breast-feeding mothers no ? safety data exists for either vaccine in pregnancy
10. 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
11. Allergic to penicillin/amoxicillin
12. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase
13. Previously been involved in a clinical trial involving experimental human pneumococcal carriage
14. Unable to give fully informed consent
15. Medication that may affect the immune system (e.g. steroids, steroid nasal spray)
16. Current acute severe febrile illness at the time of vaccination/inoculation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pneumococcal bacteria detected by classical microbiology at either day 2, 7, 14 or 21 post inoculation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pneumococcal bacteria detected by qPCR at either day 2, 7, 14 or 21 post inoculation<br> 2. Pneumococcal bacteria density at day 2, 7, 14 or 21 post inoculation<br> 3. Pneumococcal bacteria duration of carriage as shown by detection at day 2, 7, 14 or 21 post inoculation<br>