| Popis: |
Background Lassa fever run a uniquely severe course in pregnancy. There are plans for Lassa fever vaccine clinical trials in endemic West African countries. We tried to assess the perception of West African investigators to including pregnant women in these studies. Methods Interviews were conducted with eight investigators from sub-Saharan Africa. Six of them from West Africa. Data were analyzed thematically. Results Respondents had limited experience with pregnant women in clinical trials but desired a paradigm shift. They identified pregnant women's willingness, a robust community engagement strategy, and adequate safety data as enablers, while lack of safety data, persistent fears about potential harm to pregnant women and offspring, and inappropriate community engagement activities as potential barriers. Conclusion The inclusion of pregnant women in Lassa fever vaccine clinical trials should be a priority of vaccine developers. Investigators are willing to conduct these studies provided adequate measures to ensure safety is in place. |
