Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda.
Ebola virus disease
accelerated conduct
expedited approval
vaccine research
Journal
Global health action
ISSN: 1654-9880
Titre abrégé: Glob Health Action
Pays: United States
ID NLM: 101496665
Informations de publication
Date de publication:
31 12 2020
31 12 2020
Historique:
entrez:
19
10
2020
pubmed:
20
10
2020
medline:
10
3
2021
Statut:
ppublish
Résumé
The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct. Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented. Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a 'phased' study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation. The use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.
Sections du résumé
BACKGROUND
The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by
OBJECTIVE
We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct.
METHODS
Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented.
RESULTS
Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a 'phased' study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation.
CONCLUSION
The use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.
Identifiants
pubmed: 33073737
doi: 10.1080/16549716.2020.1829829
pmc: PMC7594841
doi:
Substances chimiques
Ebola Vaccines
0
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1829829Subventions
Organisme : Medical Research Council
ID : MC_UU_00027/1
Pays : United Kingdom
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