Bordetella Pertussis Colonisation Challenge Study

• Status: Recruiting
• Trial end date: 2021-02-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective controlled human challenge study consisting of two phases; Phase A:

Development of a B. pertussis human challenge model; pilot to establish the standard inoculum Phase B: Development of a modified B. pertussis human challenge model

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southampton
• Collaborators: Public Health England; University Hospital Southampton NHS Foundation Trust
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Healthy adults aged 18 to 45 years inclusive on the day of screening

• Fully conversant in the English language

• Able to communicate easily by both mobile telephone and text messaging

• Able and willing (in the investigator's opinion) to comply with all study requirements

• Written informed consent to participate in the trial

• Willingness to take a curative antibiotic regimen after inoculation with B. pertussis according to the study protocol

• Agreement to be admitted to the National Institute for Health Research (NIHR)-Clinical research facility (CRF) Southampton for 17 days for phase A (from inoculation until two days after the eradication therapy is given) and for the duration necessary for phase B, depending on phase A results

• Able to answer all questions on the informed consent quiz correctly

Exclusion Criteria:

• Individuals who have inviolable commitments within 3 months of discharge from the inpatient phase of the study to make contact with:

1. unimmunised or partially immunised children and infants aged < 1 year

2. pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact

• Individuals who have household contacts working with

1. unimmunised or partially immunised children and infants aged < 1 year

2. pregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact

• Phase A only: Volunteers will be excluded from this study if they have evidence of recent exposure to B. pertussis, as determined by anti-PT IgG ELISA (>20 IU/mL)

• B. pertussis detected on nasopharyngeal swab taken before the challenge

• Individuals who have a signs of a current infection at the time of inoculation with B. pertussis

• Individuals who have participated in other interventional clinical trials in the last 12 weeks

• Individuals who have a history of receiving B. pertussis vaccination in the last 5 years

• Individuals who have a history of never being vaccinated against B. pertussis

• Current smokers defined as having had a cigarette/cigar in the last week.

• Use of systemic antibiotics within 30 days of or during the challenge

• Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)

• Use of immunoglobulins or blood products within 3 months prior to enrolment

• History of allergic disease or reactions likely to be exacerbated by any component of the inoculum

• Contraindications to the use of azithromycin or macrolides

• Pregnancy, lactation or intention to become pregnant during the study

• Any clinically significant abnormal finding on biochemistry, haematology, toxicology or serological blood tests, urinalysis or clinical examination - in the event of abnormal test results, confirmatory repeat tests will be requested

• Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data, for example recent surgery to the nasopharynx