Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context.

ABSTRACT:

Background

Enrolling participants in clinical trials can be challenging, especially with respect to prophylactic vaccine trials. The vaccination of study personnel in Ebola vaccine trials during the 2014-2016 epidemic played a crucial role in inspiring trust and facilitating volunteer enrollment. We evaluated the ethical and methodological considerations as they applied to an ongoing phase 2 randomized prophylactic Ebola vaccine trial that enrolled healthy volunteers in Guinea, Liberia, Sierra Leone, and Mali in a non-epidemic context.

Methods

On the assumption that the personnel on site involved in executing the protocol, as well as community mobilizers (not involved in the on-site procedures), might also volunteer to enter the trial, we considered both ethical and methodol

SUBMITTER: Lhomme E 

PROVIDER: S-EPMC6624937 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature