Condition category
Infections and Infestations
Date applied
26/06/2017
Date assigned
27/06/2017
Last edited
26/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pneumococcus is a bacteria found in the nose. Small numbers of these bacteria are often found in the nose. Usually, the carrier does not know the bacteria are there. In most adults this is present at least once per year and more often in children. It could be that a small number of bacteria present in the nose (“nasal carriage”) can help to protect people against disease. Mild infections with pneumococcus are very common, such as ear infections in children. But pneumococcus can also infect the lung (causing pneumonia) or the brain (causing meningitis) or the blood (causing sepsis). These severe infections are very uncommon in healthy adults. Very young children and adults who are elderly or those who have other illnesses are more likely to become ill. In future we may be able to protect people against severe disease from pneumococcus using a vaccine. In order to develop a vaccine, there is a need to understand how the bacteria spread. This study looks at what happens when the hands of healthy volunteers are exposed to small numbers of the bacteria and they are asked to touch their noses. This aims to mimic the possible transmission route of this bacteria from people’s hands into their noses. The aim of this study is to determine the feasibility of Experimental Pneumococcal Carriage acquisition following pneumococcal transmission from hand to nostrils in order to reduce transmission.

Who can participate?
Healthy adults 18-50 years of age.

What does the study involve?
Participants are screened in order to see if they are suitable to participate. After signing consent, participants start the study, where they are administered a droplet of the bacteria on their hand or finger. Then they are asked to rub or poke their nose with their hand/finger. After this, participants are in contact with the researchers by phone for seven days. Participants attend the clinic at day two, six and nine where they provide samples from their nose. At the end of the study they are given medication to treat any bacteria if they are still carrying it.

What are the possible benefits and risks of participating?
Participants benefit from receiving financial compensation for their time and inconvenience. The risk from the tests performed in the study (such as blood tests and nasal/throat samples) is very low, as these tests are not expected to cause more than mild temporary discomfort. The study involves live bacteria, which can cause severe infection (such as pneumonia or meningitis) in people who are at high risk of infection. To minimize this risk, volunteers who are healthy and low-risk are carefully selected, and a detailed medical assessment is carried out on all potential volunteers before they start the study. In addition, a thermometer and antibiotics are provided to identify and treat infection early. The research team are available any time day or night and provide access to healthcare if required.

Where is the study run from?
Royal Liverpool University Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2017-June 2017

Who is funding the study?
1. Medical Research Council (UK)
2. Unilever (UK)

Who is the main contact?
Dr Victoria Connor
Victoria.connor@lstmed.ac.uk

Trial website

www.lstmed.ac.uk/pneumoniavaccine

Contact information

Type

Public

Primary contact

Dr Victoria Connor

ORCID ID

http://orcid.org/0000-0001-6741-8039

Contact details

Respiratory Infection Group
Department of Clinical Sciences
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33503

Study information

Scientific title

Hand to nose transmission of streptococcus pneumoniae in healthy participants – pilot study

Acronym

Study hypothesis

The aim of this study is to determine the feasibility of Experimental Pneumococcal Carriage acquisition following pneumococcal transmission from hand to nostrils.

Ethics approval

North West - Liverpool East Research Ethics Committee, 02/02/2017, ref: 17/NW/0054

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infection prevention; UKCRC code/ Disease: Infection/ Other infectious diseases

Intervention

Healthy non-smoking adult participant’s hands are exposed with well-characterised, fully sequenced penicillin-sensitive pneumococci in order to observe them for the development of pneumococcal carriage.

Initially participants are seen to discuss potential study involvement, consent obtained following time for participants to make a fully informed decision about volunteering.

After consent is received, during the week prior to the start of the study participants are screened and have baseline samples taken. This involves clinical examination and medical history, nasal wash sample collection, urine sample (pregnancy test for females), viral throat swab and blood test.

If participants are still eligible following screening they are seen a week later to start the study. The first official visit is pneumococcal exposure, where a droplet pneumococcal bacteria is administered to one hand or one finger. Participants are asked to actively attempt to facilitate transmission of pneumococci bacteria from hand to nose by either rubbing their nose (with exposed area) or by poking their nose (with exposed finger). This may be done while the bacteria is still wet or following drying time. Following this exposure day participants have daily telephone contact with a researcher (by telephone) for seven days for safety. They are also supplied a safety pack which includes thermometer for participants to take their temperatures each day for seven days, safety information leaflet and back up antibiotics if needed.

Participants attend the clinic two, six and nine days following this exposure where they undergo a nasal wash to obtain samples for analysis of nasal carriage of the bacteria. At the end of the study (day nine) we will advise participants to take three days of amoxicillin to clear carriage if they still are carrying the bacteria in their noses.

The total duration of the study (observation and follow-up) is three weeks, with a maximum of six visits (including consent visit).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Detection of 6B pneumococci is measured by using classical culture methods from nasal wash recovered from the participants at days two, six and nine.

Secondary outcome measures

1. Density and duration of pneumococcus carriage is measured using classical culture methods from nasal wash recovered at day 2, 6 and 9
2. Rate of pneumococcal carriage among participants who were expose to and attempted transmission following drying of the bacterial stock is measured using classical culture methods from nasal wash recovered at day two, six and nine
3. Rate of pneumococcal carriage among participants who were expose to and attempted transmission with wet bacteria stock is measured using classical culture methods from nasal wash recovered at day two, six and nine

Overall trial start date

01/03/2017

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18-50 years (chosen to minimise the risk of pneumococcal infection, and to allow 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
3. Access to their own mobile telephone – to ensure safety and timely communication
4. Capacity to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Previous pneumococcal vaccination
2. History of major pneumococcal illness
3. Close physical contact with at risk individuals (children under 5 years of age, immunosuppressed adults, elderly, chronic ill health) - minimise risk of pneumococcal transmission
4. Allergy to penicillin/amoxicillin
5. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection
6. Any acute dermatological illness or skin injury affecting the hands or face- confounding effects of topical medications and propensity to infection
7. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics and roacutanne.
8. Current illness, acute illness within 3 days prior to inoculation or antibiotic treatment within 2 weeks of inoculation
9. Pregnancy - minimise risk of pneumococcal disease
10. Diagnosed as diabetic
11. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
12. Have been involved in a EHPC clinical trial involving pneumococcal inoculation in the last 3 years
13. History of drug or alcohol abuse
14. History of Smoking
15. Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease
16. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease
17. Ex-smoker with a significant smoking history (> 10 pack years) – minimise risk of pneumococcal disease
18. Unable to give fully informed consent

It is anticipated that 10-15% participants of screened participants will have natural pneumococcal colonisation at the time of recruitment as demonstrated by the initial nasal wash. These individuals will be excluded from the study after screening visits.

Recruitment start date

19/04/2017

Recruitment end date

19/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospitals
Clinical Research Unit Royal Liverpool and Broadgreen University Hospitals Prescott Street
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Research and Development
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Unilever

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings from this study will be disseminated amongst the scientific community. We intend to publish our findings in a high-impact peer reviewed scientific journal and present data at appropriate local, national and international conferences by December 2018. In addition, we will produce a lay report of our findings which will be made available to all participants.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request. Data requests should be submitted to the EHPC coordinator (Catherine.Molloy@lstmed.ac.uk); these are considered by the program leads, and will be subject to data transfer agreements and ethical review if necessary.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2017: Internal review.