Lessons from the first clinical trial of a non-licensed vaccine among Ugandan adolescents: a phase II field trial of the tuberculosis candidate vaccine, MVA85A.

Autor:	Wajja A; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Namutebi M; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Apule B; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Oduru G; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Kiwanuka S; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Akello M; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Nassanga B; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Kabagenyi J; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Mpiima J; Vector Control Division, Ministry of Health of Uganda, Kampala, Uganda., Vermaak S; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK., Lawrie A; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK., Satti I; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK., Verweij J; Laboratory for Medical Microbiology and Immunology & Laboratory for Clinical Pathology,, St. Elisabeth Hospital, Tilburg, The Netherlands., Cose S; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK., Levin J; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Kaleebu P; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda., Tukahebwa E; Vector Control Division, Ministry of Health of Uganda, Kampala, Uganda., McShane H; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK., Elliott AM; MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.; Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.
Jazyk:	angličtina
Zdroj:	Wellcome open research [Wellcome Open Res] 2018 Sep 19; Vol. 3, pp. 121. Date of Electronic Publication: 2018 Sep 19 (Print Publication: 2018).
DOI:	10.12688/wellcomeopenres.14736.1
Abstrakt:	Background: A more effective vaccine for tuberculosis (TB) is a global public health priority. Vaccines under development will always need evaluation in endemic settings, most of which have limited resources. Adolescents are an important target population for a new TB vaccine and for other vaccines which are relevant at school-age. However, in most endemic settings there is limited experience of trials of investigational products among adolescents, and adolescents are not routinely vaccinated. Methods: We used Modified vaccinia Ankara-expressing Ag85A (MVA85A), a well-tolerated candidate vaccine for tuberculosis, to assess the effect of Schistosoma mansoni infection on vaccine immunogenicity among Ugandan adolescents in primary school. We describe here the challenges and lessons learned in designing and implementing this first clinical trial among Ugandan adolescents using a non-licensed vaccine. Results: The school based immunization study was feasible and adhered to Good Clinical Practice principles.  Engagement with the community and all stakeholders was critical for successful implementation of the trial. Creative and adaptable strategies were used to address protocol-specific, operational and logistical challenges. This study provided lessons and solutions that can be applied to other trials among adolescents in similar settings elsewhere, and to school-based immunization programs. Conclusion: Sufficient time and resources should be planned for community preparation and sensitization to ensure buy in and acceptance of a project of this kind. This trial shows that challenges to implementing early field trials in Africa are not insurmountable and that necessary well-planned high-quality ethical trials are feasible and should be encouraged. Trial Registration: ClinicalTrials.gov NCT02178748 03/06/2014. Competing Interests: No competing interests were disclosed.
Databáze:	MEDLINE
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