Community Perspectives Associated With the African PsA-TT (MenAfriVac) Vaccine Trials

Abstract

Background. The Meningitis Vaccine Project (MVP) was established to address epidemic meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate vaccine, PsA-TT.Methods. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death.Results. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems.Conclusions. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa.Clinical Trials Registration. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007).

New ethical considerations in vaccine trials

“…The major joint achievement of this process was to engender an atmosphere of trust that enabled the study to proceed and the community to feel properly involved. 3 In a multi-country trial of a Group A meningococcal conju-40 gate vaccine, 4 investigators found it useful to include local journalists in the liaison team on the ground. They also learned the importance of including husbands and male household heads in preliminary discussions about the trial.…”

Research on Controlled Drug Use: A Paradigm for Public Health Research in Sustainable Health

“…While bioethics has been engaged in political issues from the very start, the ethics of research with human subjects has found its own path in dealing with politics and cultural issues. Especially the procedure of obtaining informed consent has been adapted to various political and cultural circumstances in different places of the world (Idoko et al 2015). Community consent prior to or concomitant with individual consent has become a practice in the last 10 to 15 years (Embleton et al 2015).…”

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine

“…The success of any clinical study is largely dependent on community and participant support. The importance of community involvement in international clinical trials has become increasingly recognized [ 5 – 8 ].…”

“…Initial community meetings prepared by the study investigators in collaboration with partners established a format for dialogue between the research team and the population, which was maintained throughout the study. The research staff, investigators, and fieldworkers, who often belonged to these communities, played a critical role in keeping the communities engaged [ 5 ].…”

“…These meetings gave an opportunity for the study team to address questions and provide recommendations based on findings and to thank the community and the participants for their contributions. The feedback meetings also helped assure community ownership and the possibility of future collaborations [ 5 ].…”