Bordetella Pertussis Colonisation Challenge Study

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Brief Title

Bordetella Pertussis Colonisation Challenge Study

Official Title

A Human Controlled Infection Study to Establish a Safe, Reproducible and Practical Human Bordetella Pertussis Colonisation Model for the Identification of Correlates of Protection Against Colonisation (BPCCS)

Brief 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
    

Detailed Description

      This study is part of work package 2 of the Periscope consortium. The Periscope consortium
      brings together internationally renowned scientists with many years of experience in B.
      pertussis research, clinical trials, bioinformatics, immunology and public health to promote
      scientific and technological innovation in pertussis vaccine development and to foster the
      creation of a laboratory and scientific network that facilitates the testing and helps
      expedite the development of novel pertussis vaccines in Europe. This study, the development
      of a human challenge model for B. pertussis, is one of the models that will accelerate the
      development and registration of novel pertussis vaccines and will provide samples for studies
      performed within the network.

      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
      The first aim of phase A is to determine a 'standard inoculum' (SI), which results in safe
      colonisation of 70% of volunteers. This level of colonisation of 70% has been selected so
      that baseline immune profiles of individuals who are, or are not colonised following
      challenge can be assessed and biomarkers of protection from colonisation identified. It is
      acknowledged that for the future use of the human challenge model for efficacy evaluation of
      experimental vaccine candidates, it would be optimal if the percentage of subjects
      successfully colonised were at least 70%. The SI will be identified in a dose escalating or
      de-escalating experiment commencing at 103 colony forming units B. pertussis administered
      intranasally. Each group of 5 volunteers will be sequentially inoculated at half log-fold
      increasing/decreasing doses until the endpoint is reached. The experiment will be continued
      until the SI yields 10 subjects who are colonised at day 14. Volunteers will be screened to
      exclude those with evidence of recent B. pertussis infection using anti-pertussis toxin (PT)
      immunoglobulin G (IgG) ELISA as evidence to allow evaluation of seroconversion. Following the
      challenge chemical, haematological and clinical parameters will be monitored and nasal swab
      samples will be cultured at regular intervals to assure safety of the volunteers and to
      identify the presence of B. pertussis. At day 14 after the challenge, or at the onset of
      symptoms, whichever occurs soonest, eradication therapy in the form of azithromycin 500 mg
      once a day for 3 days will be given. Further mucosal and blood samples will be taken over the
      follow up period of one year.

      The second aim of phase A is to identify the 'colonisation period'; the earliest day after
      inoculation at which colonisation of the nasopharynx (as detected by culture) is observed in
      100% of those volunteers who show seroconversion at day 28. This time period will be used to
      establish the length of participation required from volunteers in future studies. The
      colonisation period will be deemed biologically relevant if B. pertussis specific mucosal and
      systemic antibodies are elicited in people who are colonised for the colonisation period. A
      quantitative PCR assay to detect B. pertussis in nasopharyngeal samples will be evaluated to
      determine if this can provide more rapid information in addition to culture.

      The third aim of phase A is to access environmental shedding of B. pertussis following nasal
      inoculation of healthy volunteers with B. pertussis. These shedding results will used to
      determine the length of admission and isolation in phase B. The shedding of B. pertussis by
      challenged volunteers will be assessed using personal aerosol samplers and environmental
      sampling. Efficacy of eradication therapy will be assessed.

      Phase B: Development of a modified B. pertussis human challenge model In phase B the pilot
      study data from phase A will be used to design a more practical model, if possible conducted
      partially in an outpatient setting, which will be conditional on safety and transmission
      evidence. The final protocol for phase B will be presented as a protocol amendment, because
      it will be based on the standard inoculum and colonisation period identified in Phase A.

      Volunteers in phase B will not be preselected to exclude those with evidence of recent B.
      pertussis infection. The standard inoculum determined in phase A will be used for all
      volunteers and eradication therapy will be given after the colonisation period based on the
      data of phase A. Approximately 30 individuals will receive the intranasal SI and as control
      group approximately 15 individuals will receive intranasal sham. Both groups will be treated
      with azithromycin for three days at the end of the colonisation period.

      Aims:

        -  To confirm that the following parameters of the model in phase B are similar to that
           seen in phase A:

             -  Volunteer safety

             -  Colonisation rate

             -  Colonisation period

             -  Genetic/expression changes in B. pertussis during challenge

             -  Environmental shedding

             -  Efficacy of eradication therapy

        -  To compare the pattern of detection of B. pertussis in nasopharyngeal samples by qPCR to
           that seen in phase A.

        -  To assess B. pertussis-specific immunity before and after inoculating healthy volunteers
           with B. pertussis, comparing the data from successfully colonised participants with the
           data from those not colonised and the control group.
    


Study Type

Interventional


Primary Outcome

Phase A - Inoculum Dose Determination

Secondary Outcome

 Phase A and B - Immune Responses to exposure to Bordetella pertussis

Condition

Whooping Cough

Intervention

Bordetella Pertussis B1917

Study Arms / Comparison Groups

 Phase A - SI
Description:  Phase A aims to determine a 'standard inoculum' dose (SI), which results in safe colonisation of 70% of volunteers.
The SI will be identified in a dose escalating or de-escalating experiment commencing at 10-3 colony forming units B. pertussis administered intranasally. Each group of volunteers will be inoculated at half log-fold increasing/decreasing doses until the endpoint is reached. The experiment will be continued until the SI yields 10 subjects who are colonised at day 14.
Intervention to be administered: Bordetella Pertussis B1917

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

80

Start Date

May 22, 2017

Completion Date

February 2, 2021

Primary Completion Date

February 2, 2021

Eligibility 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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robert C Read, MB MD FRCP, 02381204989, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03751514

Organization ID

RHM MED1396

Secondary IDs

17/SC/0006

Responsible Party

Sponsor

Study Sponsor

University of Southampton

Collaborators

 Public Health England

Study Sponsor

Robert C Read, MB MD FRCP, Principal Investigator, University of Southampton


Verification Date

February 2020