PCV and EHPC Study

Phase 1

• Conditions: Pneumococcal disease; MedDRA version: 15.1Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 15.1Level: PTClassification code 10063430Term: Hepatitis A immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005141-20-GB
• Lead Sponsor: Royal Liverpool University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-26
• Study Completion: 2014-11-07
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.