ABSTRACT
This study explored the experiences of healthcare providers (HCPs) and frontline workers who were involved in an Ebola vaccine trial in the Democratic Republic of the Congo. The researchers interviewed a total of 99 participants (HCPs and frontline workers) living and working in the Boende health district during the period of the study, from February to March 2022. These individuals included a mix of trial participants and non-trial participants (staff of the trial, local health authorities, and head nurses of health centers). In-depth individual interviews, as well as focus group discussions (FGDs), were used to understand interviewees' experiences and perceptions. The data were analyzed to identify the main themes. The findings unveiled a multitude of positive experiences among interviewees/FGD participants. The commitment of the trial investigators to improve the study site and to equip the volunteers with necessary skills and knowledge greatly contributed to a positive trial experience. However, some interviewees felt that the reimbursement for time and travel expenses during their trial visits was insufficient in comparison with their expectations. Additionally, there were expressions of worry about the frequency of blood draws during scheduled trial visits. Our findings emphasize the critical importance of addressing and continuously considering the perspectives and concerns of trial participants before designing and implementing vaccine trials. By actively incorporating their inputs, researchers can mitigate concerns and tailor communication strategies, potentially enhancing the overall success and impact of the vaccine trial.
ABSTRACT
Pregnant women are generally excluded from clinical research over safety concerns. However, demands to include them in clinical vaccine development have intensified after recent COVID-19, Ebola, and Lassa fever outbreaks given the disproportionate effect of these diseases on pregnant women and/or their foetuses. Numerous studies highlighted the scarcity of safety data for therapeutic interventions in pregnant women. Nevertheless, only a small number have assessed the number of vaccine trials including this population. Therefore, we searched for phase 3 and 4 vaccine clinical trials in healthy populations registered between 2018 and 2023 in clinicaltrials.gov and the International Clinical Trial Registry Platform. Out of 400 registered vaccine trials matching our inclusion criteria, 217 (54 %) were industry-sponsored, and 222 (56 %) had COVID-19 as a target. We found 22 studies (6 %) that either were designed for pregnant women or included them as part of a larger population. Out of these 22 trials, 13 were designed specifically for pregnant women; seven of these were maternal vaccines aiming at protecting the foetus, namely pertussis (3), Respiratory Syncytial Virus (RSV) (3), and meningitis plus tetanus (1) vaccines, and six others targeted either flu (3), COVID-19 (2) or Ebola (1). Only the RSV and Ebola vaccine trials were industry-sponsored. We also found that nine studies targeting the general population included pregnant women. These focused on COVID-19 (3), flu (2), COVID-19 + flu (2), Ebola (1), and Hepatitis B (1). None of these studies was industry-sponsored. Our findings show that a gap still exists in terms of pregnant women's inclusion in vaccine trials. Such a gap needs to be tackled urgently to minimise the devastating effects that a future infectious disease outbreak could have on this population. This study can inform future demands for increased inclusion, especially in industry-sponsored trials, as it provides an overview of the current vaccine trials scene.
