Developing better pneumococcal vaccines to cover important disease-causing strains: a healthy volunteer challenge study

Not Applicable

Completed

• Conditions: Pneumococcus infection; Infections and Infestations

• Registration Number: ISRCTN17879306
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-04
• Study Completion: 2023-11-22
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Healthy young adults aged 18-50 years (inclusive). This age range minimises the risk of invasive pneumococcal infection and allows comparison with previously published experimental work done by our group.
2. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement, enabling valid consent to be given
3. Access to their own mobile telephone - to ensure safety and timely communication
4. Capacity to give informed consent

Exclusion Criteria

1. Currently involved in another study unless observational or non-interventional, excluding the EHPC bronchoscopy study (at the discretion of the study team). This is to ensure no harm comes to the participants through over-sampling.
2. Participant in any previous EHPC trial in the past year
3. Participant in previous EHPC trial inoculated with SPN3 in the last 3 years
4. Participant in EHPC Pneumo 2 trial
5. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in babies born in the UK since 2005) or PCV10. This can be self-reported or confirmed from GP questionnaire (GPQ) if deemed necessary at clinician discretion.
6. Allergy to penicillin/amoxicillin
7. Health history (self-reported or confirmed by GPQ or medical summary if felt to be necessary at clinician discretion):
8. Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
9. Medication that may affect the immune system e.g., steroids, inflammation altering or disease-modifying anti-rheumatoid drugs
10. Long term use of antibiotics for chronic infection
11. Major pneumococcal illness requiring hospitalisation in the last 10 years
12. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
13. Significant mental health problems (uncontrolled condition or requiring previous admission to a psychiatric unit) that would impair ability to participate
14. Direct caring role or close contact with individuals at higher risk of infection during the inoculation period if personal protective equipment (PPE) not worn:
14.1. Children under 5 years of age
14.2. Adults with chronic ill health or immunosuppression
14.3. Hospital patients
15. Current or ex-smoker (daily cigarettes, daily e-cigarettes/vaping and daily smoking of recreational drugs) in the last 6 months. Participants who smoke <5 cigarettes per week may be included.
16. Previous significant smoking history (>20 cigarettes per day for 20 years or equivalent [>20 pack years])
17. Biologically female participants of child-bearing potential (WOCBP) who are:
17.1. Currently pregnant/lactating
17.2. Intending on becoming pregnant during the study
17.3. Not deemed to have effective birth control
18. History of or current drug or alcohol abuse:
18.1. Men should not drink >3 units/day regularly
18.2. Women should not drink >2 units/day regularly
19. Overseas travel planned in follow up period of study visits
20. Natural SPN3 colonisation in baseline nasal wash – if a participant is colonised with non-SPN3 pneumococcus, they can be included as part of exploratory analyses, but would not be included in the primary analysis
21. STOP criteria – participants who meet STOP criteria at the time of screening:
21.1. Clinical history and examination: STOP if unexplained or concerning findings on history or examination
21.2. Severe adverse event (SAE) or research-related injury (RRI): STOP if related SAE or RRI reported
21.3. Engagement with research team: STOP if the research team have concerns about the participant’s ability to commit to frequent communication and safety checks
21.4. Full blood count (FBC):
21.5.1. STOP if Hb <10 g/l
21.5.2. STOP if total WCC <1.5 x 10e9/l
21.5.3. STOP if total WCC >12 x 10e9/l
21.5.4. STOP if platelets <75 x 10e9/l
21.6. Resting SpO2: STOP if <94%
21.7. Illness during the study: STOP if participant develops a me

Study & Design

• Study Type: Observational
• Study Design: Not specified