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Article: Chapter Controlled Human Infection with Bordetella pertussis.

de Graaf, H / Gbesemete, D / Read, R C

Current topics in microbiology and immunology

2023

Abstract: Bordetella pertussis, a slow-growing Gram-negative coccobacillus and the causative agent of whooping cough, is one of the leading causes of vaccine-preventable death and morbidity globally. A state of asymptomatic human carriage has not yet been ... ...

Abstract	Bordetella pertussis, a slow-growing Gram-negative coccobacillus and the causative agent of whooping cough, is one of the leading causes of vaccine-preventable death and morbidity globally. A state of asymptomatic human carriage has not yet been demonstrated by population studies but is likely to be an important reservoir for community transmission of infection. Such a carriage state may be a target for future vaccine strategies. This chapter presents a short summary of the characteristics of B. pertussis, which should be taken into account when developing a human challenge model and any future experimental medicine interventions. Three studies involving deliberate infection with B. pertussis have been described to date. The first of these was a scientifically and ethically unacceptable paediatric challenge study involving four children in 1930. The second was an investigation of a putative live vaccine using a genetically modified and attenuated strain of B. pertussis. Finally, a systematically constructed human challenge model using a wild-type, potentially pathogenic strain has been established. The latter study has demonstrated that deliberate induction of asymptomatic colonisation in humans is safe and immunogenic, with colonised participants exhibiting seroconversion to pertussis antigens. It has also shown nasal wash to be a more sensitive method of detecting the presence of B. pertussis than either pernasal swab or throat swab, and that B. pertussis carriage can be cleared effectively with Azithromycin. The development of this wild-type B. pertussis human challenge model will allow the investigation of host-pathogen and facilitate future vaccine development.
Language	English
Publishing date	2023-03-25
Publishing country	Germany
Document type	Journal Article
ISSN	0070-217X
ISSN	0070-217X
DOI	10.1007/82_2022_260
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Article ; Online: Exploring the acceptability of controlled human infection with SARSCoV2-a public consultation.

Gbesemete, D / Barker, M / Lawrence, W T / Watson, D / de Graaf, H / Read, R C

BMC medicine

2020 Volume 18, Issue 1, Page(s) 209

Abstract: Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to ... ...

Abstract	Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.
MeSH term(s)	Adult ; Attitude to Health ; Betacoronavirus ; Biomedical Research/ethics ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/prevention & control ; Drug Development ; Female ; Focus Groups ; Humans ; Male ; Pandemics/prevention & control ; Patient Selection ; Pneumonia, Viral/prevention & control ; Public Opinion ; Referral and Consultation ; SARS-CoV-2 ; United Kingdom ; Viral Vaccines/therapeutic use ; Young Adult
Chemical Substances	COVID-19 Vaccines ; Viral Vaccines
Keywords	covid19
Language	English
Publishing date	2020-07-07
Publishing country	England
Document type	Letter
ZDB-ID	2131669-7
ISSN	1741-7015 ; 1741-7015
ISSN (online)	1741-7015
ISSN	1741-7015
DOI	10.1186/s12916-020-01670-2
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Article ; Online: Psychological distress experienced by parents caring for an immunosuppressed child during the COVID-19 pandemic.

Driessens, Corine / Mills, Lynne / Patel, Ravin / Culliford, David / Gbesemete, Diane / Lee, Emma / Shaunak, Meera / Chappell, Harry / Faust, Saul N / de Graaf, Hans

Journal of psychiatric research

2023 Volume 161, Page(s) 273–281

Abstract: The COVID-19 pandemic has proved unique in both its unpredictability and the extent to which it has continued to impact on daily life since March 2020. Among the immunosuppressed population the challenges of the COVID-19 pandemic are cumulative to the ... ...

Abstract	The COVID-19 pandemic has proved unique in both its unpredictability and the extent to which it has continued to impact on daily life since March 2020. Among the immunosuppressed population the challenges of the COVID-19 pandemic are cumulative to the ever-present challenges of living with a long-term condition. This prospective longitudinal study explored patterns of concern experienced by 467 British parents caring for an immunosuppressed child during the first 2 years of the COVID-19 pandemic and related this to parental mental wellbeing. Most parents slowly adapted or were resilient to the ever-changing stressors of the COVID-19 pandemic. However, 12% experienced high levels of concern throughout the first 2 years of the pandemic. This group was also more likely to report emotional mental health problems towards the end of this period. The experience of emotional mental health problems among parents caring for an immunosuppressed child was related to low household income, single parenting, difficult access to greenspace, and higher level of exposure to COVID positive cases and COVID restrictions (North of England). Parents reported that optimism, reduction of isolation, and support promoted coping and management of the challenges of the COVID-19 pandemic. More reliable COVID information and periodic medical-condition-specific guidance would have been appreciated. These findings can increase clinical awareness of high-risk parental groups and make an important contribution to the planning of appropriate targeted psychological family interventions.
MeSH term(s)	Child ; Humans ; COVID-19 ; Pandemics ; Longitudinal Studies ; Prospective Studies ; Psychological Distress ; Parents
Language	English
Publishing date	2023-03-16
Publishing country	England
Document type	Journal Article
ZDB-ID	3148-3
ISSN	1879-1379 ; 0022-3956
ISSN (online)	1879-1379
ISSN	0022-3956
DOI	10.1016/j.jpsychires.2023.03.021
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Article ; Online: Parental concern for clinically vulnerable child during first 18 months of the COVID pandemic.

Driessens, Corine / Mills, Lynne / Culliford, David / Patel, Ravin / Lee, Emma / Gbesemete, Diane / Chappell, Harry / Shaunak, Meera / Faust, Saul N / de Graaf, Hans

Pediatric research

2022 Volume 94, Issue 1, Page(s) 222–230

Abstract: Background: The uncertainties surrounding the COVID-19 pandemic have been associated with increased parental concern. The aim of this study is to explore if this increased level of concern is associated with certain individual/household characteristics ... ...

Abstract	Background: The uncertainties surrounding the COVID-19 pandemic have been associated with increased parental concern. The aim of this study is to explore if this increased level of concern is associated with certain individual/household characteristics or if parents adapted to the ever-changing realities of the COVID-19 pandemic over time. Methods: This prospective study explored COVID-19 concern trajectories and associated family characteristics of 765 UK parents caring for an immunosuppressed child during the first 18 months of the pandemic using growth mixture modelling. Qualitative analysis was performed to examine in more detail the source of concern. Results: Four different trajectories of parental COVID-19 concern were identified. Ongoing very high concern was associated with caring for children with nephrotic or respiratory disease; having a child on an organ transplant waiting list; residency in the North of England; or parental vocational inactivity. Explicit concerns voiced by the parents generally followed national trends, but vulnerable status specific concerns were also reported. Conclusion: Diagnosis and prescribed medication of the immunosuppressed child, geographical location, household composition, and employment status of parent were associated with the different concern trajectories. This information can be helpful in targeting psychological family care where it is most needed. Impact: Many British parents caring for a clinically vulnerable child during the first 18 months of the COVID-19 pandemic showed high levels of concern with little sign of psychological adaptation. Consistent with findings from non-vulnerable populations, parents mentioned the impact of shielding and repeated isolation on their child's education, social life, and mental health. Unique to the clinically vulnerable population, parents were worried about child's health status, impact of delayed healthcare, and were confused by the contradictory information received from government, doctors, and media. Psychological family care can be targeted to those parents at greater risk for high levels of concern.
MeSH term(s)	Humans ; Child ; Pandemics ; Prospective Studies ; COVID-19 ; Longitudinal Studies ; Health Status
Language	English
Publishing date	2022-11-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-022-02371-7
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Article: Exploring the acceptability of controlled human infection with SARSCoV2-a public consultation

Gbesemete, D / Barker, M / Lawrence, W T / Watson, D / de Graaf, H / Read, R C

BMC Med

Abstract	Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #656279
Database	COVID19

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Article ; Online: The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic.

Piggin, Maria / Smith, Emma / Mankone, Peter / Ndegwa, Leah / Gbesemete, Diane / Pristerà, Philippa / Bahrami-Hessari, Michael / Johnson, Halle / Catchpole, Andrew P / Openshaw, Peter J M / Chiu, Christopher / Read, Robert C / Ward, Helen / Barker, Caroline

Epidemics

2022 Volume 41, Page(s) 100626

Abstract: High quality health care research must involve patients and the public. This ensures research is important, relevant and acceptable to those it is designed to benefit. The world's first human challenge study with SARS-CoV-2 undertook detailed public ... ...

Abstract	High quality health care research must involve patients and the public. This ensures research is important, relevant and acceptable to those it is designed to benefit. The world's first human challenge study with SARS-CoV-2 undertook detailed public involvement to inform study design despite the urgency to review and establish the study. The work was integral to the UK Research Ethics Committee review and approval of the study. Discussion with individuals from ethnic minorities within the UK population supported decision-making around the study exclusion criteria. Public review of study materials for consent processes led to the addition of new information, comparisons and visual aids to help volunteers consider the practicalities and risks involved in participating. A discussion exploring the acceptability of a human challenge study with SARS-CoV-2 taking place in the UK, given the current context of the pandemic, identified overall support for the study. Public concern for the wellbeing of trial participants, as a consequence of isolation, was identified. We outline our approach to public involvement and its impact on study design.
MeSH term(s)	Humans ; SARS-CoV-2 ; COVID-19/epidemiology ; Pandemics
Language	English
Publishing date	2022-09-01
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2467993-8
ISSN	1878-0067 ; 1755-4365
ISSN (online)	1878-0067
ISSN	1755-4365
DOI	10.1016/j.epidem.2022.100626
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Article: Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study.

Barker, Caroline / Collet, Katharine / Gbesemete, Diane / Piggin, Maria / Watson, Daniella / Pristerà, Philippa / Lawerence, Wendy / Smith, Emma / Bahrami-Hessari, Michael / Johnson, Halle / Baker, Katherine / Qavi, Ambar / McGrath, Carmel / Chiu, Christopher / Read, Robert C / Ward, Helen

Wellcome open research

2022 Volume 7, Page(s) 49

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2022-02-10
Publishing country	England
Document type	Journal Article
ISSN	2398-502X
ISSN	2398-502X
DOI	10.12688/wellcomeopenres.17516.1
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Article ; Online: Protocol for a controlled human infection with genetically modified

Gbesemete, Diane / Laver, Jay Robert / de Graaf, Hans / Ibrahim, Muktar / Vaughan, Andrew / Faust, Saul / Gorringe, Andrew / Read, Robert Charles

BMJ open

2019 Volume 9, Issue 4, Page(s) e026544

Abstract: Introduction: Neisseria lactamica: Methods and analysis: Healthy adult volunteers aged 18-45 years will receive an intranasal inoculation of either the NadA containing strain of : Ethics and dissemination: This study has been approved by the ... ...

Abstract	Introduction: Neisseria lactamica Methods and analysis: Healthy adult volunteers aged 18-45 years will receive an intranasal inoculation of either the NadA containing strain of Ethics and dissemination: This study has been approved by the Department for Environment, Food and Rural Affairs and South Central Oxford A Research Ethics Committee (reference: 18/SC/0133). Findings will be published in peer-reviewed open-access journals as soon as possible. Trial registration number: NCT03630250; Pre-results.
MeSH term(s)	Adhesins, Bacterial/biosynthesis ; Adhesins, Bacterial/immunology ; Adolescent ; Adult ; Antigens/immunology ; Biomedical Research ; Humans ; Meningococcal Vaccines/immunology ; Microorganisms, Genetically-Modified ; Middle Aged ; Neisseria lactamica/genetics ; Neisseria lactamica/metabolism ; Neisseria meningitidis/immunology ; Prospective Studies ; Research Design ; Young Adult
Chemical Substances	Adhesins, Bacterial ; Antigens ; Meningococcal Vaccines
Language	English
Publishing date	2019-05-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2747269-3
ISSN	2044-6055 ; 2044-6055 ; 2053-3624
ISSN (online)	2044-6055
ISSN	2044-6055 ; 2053-3624
DOI	10.1136/bmjopen-2018-026544
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Article ; Online: COVID-19 symptom surveillance in immunocompromised children and young people in the UK: a prospective observational cohort study.

Shaunak, Meera / Patel, Ravin / Driessens, Corine / Mills, Lynne / Leahy, Alice / Gbesemete, Diane / Owens, Daniel R / Lucas, Jane S / Faust, Saul N / de Graaf, Hans

BMJ open

2021 Volume 11, Issue 3, Page(s) e044899

Abstract: Objectives: To describe the frequency of symptoms compatible with SARS-CoV-2 infection in immunocompromised children and young people in the UK during the SARS-CoV-2 pandemic. To describe patient/parent anxiety regarding SARS-CoV-2 infection in this ... ...

Abstract	Objectives: To describe the frequency of symptoms compatible with SARS-CoV-2 infection in immunocompromised children and young people in the UK during the SARS-CoV-2 pandemic. To describe patient/parent anxiety regarding SARS-CoV-2 infection in this cohort. Design: A prospective observational cohort study. Setting: 46 centres across the UK between 16 March and 4 July 2020. A weekly online questionnaire based on the International Severe Acute Respiratory and emerging Infections Consortium-WHO Case Report Form was used to collect participant reported data on symptoms, test results, National Health Service attendance, hospital admission and impact on daily life. Participants: 1490 immunocompromised children, defined as those requiring an annual influenza vaccination due to their underlying condition or medication. Main outcome measures: Incidence of SARS-CoV-2-like symptoms and patient/parent anxiety score. Results: Over 16 weeks during the first wave of the pandemic, no SARS-CoV-2 infection was diagnosed in this large immunocompromised paediatric cohort (median age 11 years, 54.4% female). 110 symptomatic participants underwent a test for SARS-CoV-2; all were negative. 922 (67.4%) participants reported at least one symptom consistent with suspected SARS-CoV-2 infection over the study period. 476 (34.8%) reported three or more symptoms. The most frequently reported symptoms included joint pain, fatigue, headache, nausea and muscle pain. SARS-CoV-2 testing during this period was performed on admitted patients only. 137 participants had their medication suspended or changed during the study period due to assumed COVID-19 disease risk. 62% reported high levels of anxiety (scores of 7-10 out of 10) at the start of the study, with anxiety levels remaining high throughout the study period. Conclusions: Although symptoms related to SARS-CoV-2 infection in children were common, there were no positive tests in this large immunocompromised cohort. Symptom-based screening to facilitate early detection of SARS-CoV-2 infection may not be helpful in these individuals. Patient/parent anxiety about SARS-CoV-2 infection was high. Trial registration number: NCT04382508.
MeSH term(s)	Adolescent ; Anxiety ; COVID-19/epidemiology ; COVID-19 Testing ; Child ; Female ; Humans ; Male ; Prospective Studies ; State Medicine ; United Kingdom/epidemiology
Language	English
Publishing date	2021-03-17
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-044899
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Article ; Online: Exploring the acceptability of controlled human infection with SARSCoV2—a public consultation

D. Gbesemete / M. Barker / W. T. Lawrence / D. Watson / H. de Graaf / R. C. Read

BMC Medicine, Vol 18, Iss 1, Pp 1-

2020 Volume 8

Abstract: Abstract Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers ... ...

Abstract	Abstract Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20–40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.
Keywords	Controlled human infection model ; SARSCoV2 ; COVID-19 ; Public consultation ; Medicine ; R ; covid19
Subject code	306
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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