The promise, problems, and pitfalls of including pregnant women in clinical trials of Lassa fever vaccine: a qualitative assessment of sub-Sahara Africa investigators' perception

Abstract

Introduction: Lassa fever runs a uniquely severe course in pregnancy. There are plans for Lassa fever vaccine clinical trials in endemic West African countries. We assessed the perception of West African investigators to include pregnant women in these studies.

Methods: interviews were conducted with eight sub-Saharan African investigators. These investigators, listed as speakers at the 9^th European and developing countries clinical trials partnership (EDCTP) congress and had clinical research experience in sub-Saharan Africa, were purposefully included as study participants. Six are from West Africa. The information was analyzed thematically.

Results: we interviewed eight (six in-person and two on the phone) out of fifteen earmarked investigators. 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.