Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations]
Background: Tuberculosis (TB) remains a major challenge in many domains including diagnosis, pathogenesis, prevention, treatment, drug resistance and long-term protection of the public health by vaccination. A controlled human infection model (CHIM) could potentially facilitate breakthroughs in each...
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| Format: | Article |
| Language: | English |
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Wellcome
2023-02-01
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| Series: | Wellcome Open Research |
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| Online Access: | https://wellcomeopenresearch.org/articles/8-71/v1 |
| _version_ | 1797855371001331712 |
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| author | Keertan Dedha Henry Mwandumba Brian D. Robertson Nimisha Raj Sharma Naomi Walker Simon Sichone Shobana Balasingam Ben Morton Stephen B. Gordon Phoebe Hazenberg Kondwani Jambo Anthony E. Chirwa Joanne Flynn Zacharia Kafuko Daniela M. Ferreira Giancarlo A. Biagini Sarah Fortune Helen McShane |
| author_facet | Keertan Dedha Henry Mwandumba Brian D. Robertson Nimisha Raj Sharma Naomi Walker Simon Sichone Shobana Balasingam Ben Morton Stephen B. Gordon Phoebe Hazenberg Kondwani Jambo Anthony E. Chirwa Joanne Flynn Zacharia Kafuko Daniela M. Ferreira Giancarlo A. Biagini Sarah Fortune Helen McShane |
| author_sort | Keertan Dedha |
| collection | DOAJ |
| description | Background: Tuberculosis (TB) remains a major challenge in many domains including diagnosis, pathogenesis, prevention, treatment, drug resistance and long-term protection of the public health by vaccination. A controlled human infection model (CHIM) could potentially facilitate breakthroughs in each of these domains but has so far been considered impossible owing to technical and safety concerns. Methods: A systematic review of mycobacterial human challenge studies was carried out to evaluate progress to date, best possible ways forward and challenges to be overcome. We searched MEDLINE (1946 to current) and CINAHL (1984 to current) databases; and Google Scholar to search citations in selected manuscripts. The final search was conducted 3rd February 2022. Inclusion criteria: adults ≥18 years old; administration of live mycobacteria; and interventional trials or cohort studies with immune and/or microbiological endpoints. Exclusion criteria: animal studies; studies with no primary data; no administration of live mycobacteria; retrospective cohort studies; case-series; and case-reports. Relevant tools (Cochrane Collaboration for RCTs and Newcastle-Ottawa Scale for non-randomised studies) were used to assess risk of bias and present a narrative synthesis of our findings. Results: The search identified 1,388 titles for review; of these 90 were reviewed for inclusion; and 27 were included. Of these, 15 were randomised controlled trials and 12 were prospective cohort studies. We focussed on administration route, challenge agent and dose administered for data extraction. Overall, BCG studies including fluorescent BCG show the most immediate utility, and genetically modified Mycobacteria tuberculosis is the most tantalising prospect of discovery breakthrough. Conclusions: The TB-CHIM development group met in 2019 and 2022 to consider the results of the systematic review, to hear presentations from many of the senior authors whose work had been reviewed and to consider best ways forward. This paper reports both the systematic review and the deliberations. Registration: PROSPERO (CRD42022302785; 21 January 2022). |
| first_indexed | 2024-04-09T20:22:40Z |
| format | Article |
| id | doaj.art-f3ba22777830446ab853f538dc4a7195 |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-04-09T20:22:40Z |
| publishDate | 2023-02-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-f3ba22777830446ab853f538dc4a71952023-03-31T01:00:00ZengWellcomeWellcome Open Research2398-502X2023-02-01820808Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations]Keertan Dedha0Henry Mwandumba1Brian D. Robertson2Nimisha Raj Sharma3Naomi Walker4Simon Sichone5Shobana Balasingam6Ben Morton7https://orcid.org/0000-0002-6164-2854Stephen B. Gordon8https://orcid.org/0000-0001-6576-1116Phoebe Hazenberg9Kondwani Jambo10https://orcid.org/0000-0002-3195-2210Anthony E. Chirwa11Joanne Flynn12Zacharia Kafuko13Daniela M. Ferreira14https://orcid.org/0000-0002-0594-0902Giancarlo A. Biagini15Sarah Fortune16Helen McShane17https://orcid.org/0000-0002-2126-5142University of Cape Town, Cape Town, South AfricaMalawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, MalawiImperial College London, London, UKWellcome Trust, London, UKLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKMalawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, MalawiWellcome Trust, London, UKLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKMalawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, MalawiLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKMalawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, MalawiMalawi Liverpool Wellcome Trust Clinical Research Programme, Blantyre, MalawiCentre for Vaccine Research, University of Pittsburgh, Pittsburgh, Pennsylvania, USA1Day Africa, 1Day Sooner, Lusaka Province, ZambiaLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKLiverpool School of Tropical Medicine, Liverpool, L3 5QA, UKHarvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USAThe Jenner Institute, University of Oxford, Oxford, UKBackground: Tuberculosis (TB) remains a major challenge in many domains including diagnosis, pathogenesis, prevention, treatment, drug resistance and long-term protection of the public health by vaccination. A controlled human infection model (CHIM) could potentially facilitate breakthroughs in each of these domains but has so far been considered impossible owing to technical and safety concerns. Methods: A systematic review of mycobacterial human challenge studies was carried out to evaluate progress to date, best possible ways forward and challenges to be overcome. We searched MEDLINE (1946 to current) and CINAHL (1984 to current) databases; and Google Scholar to search citations in selected manuscripts. The final search was conducted 3rd February 2022. Inclusion criteria: adults ≥18 years old; administration of live mycobacteria; and interventional trials or cohort studies with immune and/or microbiological endpoints. Exclusion criteria: animal studies; studies with no primary data; no administration of live mycobacteria; retrospective cohort studies; case-series; and case-reports. Relevant tools (Cochrane Collaboration for RCTs and Newcastle-Ottawa Scale for non-randomised studies) were used to assess risk of bias and present a narrative synthesis of our findings. Results: The search identified 1,388 titles for review; of these 90 were reviewed for inclusion; and 27 were included. Of these, 15 were randomised controlled trials and 12 were prospective cohort studies. We focussed on administration route, challenge agent and dose administered for data extraction. Overall, BCG studies including fluorescent BCG show the most immediate utility, and genetically modified Mycobacteria tuberculosis is the most tantalising prospect of discovery breakthrough. Conclusions: The TB-CHIM development group met in 2019 and 2022 to consider the results of the systematic review, to hear presentations from many of the senior authors whose work had been reviewed and to consider best ways forward. This paper reports both the systematic review and the deliberations. Registration: PROSPERO (CRD42022302785; 21 January 2022).https://wellcomeopenresearch.org/articles/8-71/v1Human infection studies tuberculosis TB BCG bacille Calmette Guerin vaccineeng |
| spellingShingle | Keertan Dedha Henry Mwandumba Brian D. Robertson Nimisha Raj Sharma Naomi Walker Simon Sichone Shobana Balasingam Ben Morton Stephen B. Gordon Phoebe Hazenberg Kondwani Jambo Anthony E. Chirwa Joanne Flynn Zacharia Kafuko Daniela M. Ferreira Giancarlo A. Biagini Sarah Fortune Helen McShane Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] Wellcome Open Research Human infection studies tuberculosis TB BCG bacille Calmette Guerin vaccine eng |
| title | Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_full | Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_fullStr | Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_full_unstemmed | Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_short | Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi [version 1; peer review: 2 approved, 1 approved with reservations] |
| title_sort | practical considerations for a tb controlled human infection model tb chim the case for tb chim in africa a systematic review of the literature and report of 2 workshop discussions in uk and malawi version 1 peer review 2 approved 1 approved with reservations |
| topic | Human infection studies tuberculosis TB BCG bacille Calmette Guerin vaccine eng |
| url | https://wellcomeopenresearch.org/articles/8-71/v1 |
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