Publications by authors named "Gwen Lemey"

Background: Iris scanning has increasingly been used for biometric identification over the past decade, with continuous advancements and expanding applications. To better understand the acceptability of this technology, we report the long-term experiences of health care providers and frontline worker participants with iris scanning as an identification tool in the EBL2007 Ebola vaccine trial conducted in the Democratic Republic of the Congo.

Objective: This study aims to document the long-term experiences of using iris scanning for identity verification throughout the vaccine trial.

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The Democratic Republic of the Congo (DRC) struggles with low full childhood vaccination coverage (around 50 %) and a high children-under-five mortality rate (79 deaths per 1000 live births). This situation is potentially exacerbated by vaccine hesitancy, which was identified by the World Health Organization (WHO) as one of the top 10 global health threats in 2019. To gain deeper insights into levels of vaccine confidence possibly influencing vaccination coverage, we explored perceptions and attitudes towards childhood and adult vaccines in Boende (Tshuapa province, western DRC), which experienced an Ebola outbreak in 2014 and hosted the EBL2007 Ebola vaccine trial (2019-2022).

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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).

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Article Synopsis
  • There are no clear guidelines for providing extra medical care in clinical trials in places with limited resources, so they evaluated a plan used in a vaccine trial in the Democratic Republic of the Congo.
  • The study included 655 healthcare workers, and many used the extra care for side effects from the vaccine, but not everyone reported their experiences.
  • They found that the plan was possible to use, but only a small amount of the trial's budget was actually spent on it, and how often it was used depended on where the participants lived and what type of healthcare they received.
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Background: Health-care providers and front-line workers are at risk of contracting Ebola virus disease during an Ebola virus outbreak and consequently of becoming drivers of the disease. We aimed to assess the long-term immunogenicity of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen and the safety of and immune memory response to an Ad26.

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Background: The long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants' retention and understanding of the trial information after two years of participation in a vaccine trial.

Methods: In total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC).

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Conducting a vaccine trial in a low- and middle-income country (LMIC) can present unique challenges and lessons learned. This Ebola vaccine trial, enrolling 699 healthcare providers and frontliners and jointly set up by the University of Antwerp (Sponsor) and the University of Kinshasa (Principal Investigator (PI)), was conducted in Boende, a remote city in the Democratic Republic of the Congo (DRC), between December 2019 and October 2022 (ClinicalTrials.gov: NCT04186000).

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Since the largest Ebola outbreak in West Africa (2013-2016) highlighted the potential threat of the Ebola virus to the world, several vaccines have been under development by different pharmaceutical companies. To obtain vaccine licensure, vaccine trials assessing the safety, immunogenicity and efficacy of new vaccines among different populations (e.g.

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Implementing an Ebola vaccine trial in a remote area in the Democratic Republic of the Congo (DRC), and being confronted with a dysfunctional health care system and acute unmet health needs of participants, ethical considerations were made regarding the ancillary care obligations of the sponsor and researchers. Spurred by the occurrence of non-related (serious) adverse events (NR-SAEs), the Universities of Antwerp and Kinshasa jointly developed an algorithm, accompanied by an algorithm policy. The algorithm consists of a set of consecutive questions with binary response options, leading to structured, non-arbitrary and consistent support and management for each NR-SAE.

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