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Research in practice
Development of a TB vaccine trial site in Africa and lessons from the Ebola experience.
Grace Kaguthi
Kenya Medical Research Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0003-3644-1791
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Public Health.
Tuberculosis is the deadliest infection of our time. In contrast, about 11,000 people died of Ebola between 2014 and 2016. Despite this manifest difference in mortality, there is now a vaccine licensed in the United States and by the European Medicines Agency, with up to 100% efficacy against Ebola. The developments that led to the trialing of the Ebola vaccine were historic and unprecedented. The single licensed TB vaccine (BCG) has limited efficacy. There is a dire need for a more efficacious TB vaccine. To deploy such vaccines, trials are needed in sites that combine high disease incidence and research infrastructure. We describe our twelve-year experience building a TB vaccine trial site in contrast to the process in the recent Ebola outbreak. There are additional differences. Relative to the Ebola pipeline, TB vaccines have fewer trials and a paucity of government and industry led trials. While pathogens have varying levels of difficulty in the development of new vaccine candidates, there yet appears to be greater interest in funding and coordinating Ebola interventions. TB is a global threat that requires similar concerted effort for elimination.
Keywords
vaccines, Ebola, Tuberculosis, trials, sites, emerging infectious diseases
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CURRENT STATUS: Published
Version 2
Posted 31 May, 2020
No comments provided
Editorial decision: Minor revision
On 18 May, 2020
Review #2 received
Received 12 May, 2020
Review #3 received
Received 12 May, 2020
Review #1 received
Received 09 May, 2020
Reviewer #2 agreed
On 21 Apr, 2020
Reviewer #3 agreed
On 21 Apr, 2020
Reviewer #1 agreed
On 13 Apr, 2020
Reviewers invited
Invitations sent on 30 Mar, 2020
Submission checks complete
On 27 Mar, 2020
Editor invited
On 27 Mar, 2020
Editor assigned
On 27 Mar, 2020
First submitted
On 24 Mar, 2020
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This preprint is under consideration at BMC Public Health. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research in practice
Development of a TB vaccine trial site in Africa and lessons from the Ebola experience.
Grace Kaguthi
Kenya Medical Research Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0003-3644-1791
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 31 May, 2020
No comments provided
Editorial decision: Minor revision
On 18 May, 2020
Review #2 received
Received 12 May, 2020
Review #3 received
Received 12 May, 2020
Review #1 received
Received 09 May, 2020
Reviewer #2 agreed
On 21 Apr, 2020
Reviewer #3 agreed
On 21 Apr, 2020
Reviewer #1 agreed
On 13 Apr, 2020
Reviewers invited
Invitations sent on 30 Mar, 2020
Submission checks complete
On 27 Mar, 2020
Editor invited
On 27 Mar, 2020
Editor assigned
On 27 Mar, 2020
First submitted
On 24 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Public Health.
Tuberculosis is the deadliest infection of our time. In contrast, about 11,000 people died of Ebola between 2014 and 2016. Despite this manifest difference in mortality, there is now a vaccine licensed in the United States and by the European Medicines Agency, with up to 100% efficacy against Ebola. The developments that led to the trialing of the Ebola vaccine were historic and unprecedented. The single licensed TB vaccine (BCG) has limited efficacy. There is a dire need for a more efficacious TB vaccine. To deploy such vaccines, trials are needed in sites that combine high disease incidence and research infrastructure. We describe our twelve-year experience building a TB vaccine trial site in contrast to the process in the recent Ebola outbreak. There are additional differences. Relative to the Ebola pipeline, TB vaccines have fewer trials and a paucity of government and industry led trials. While pathogens have varying levels of difficulty in the development of new vaccine candidates, there yet appears to be greater interest in funding and coordinating Ebola interventions. TB is a global threat that requires similar concerted effort for elimination.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5