Setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned

Matuvanga, Trésor Zola; Larivière, Ynke; Lemey, Gwen; Bie, Jessie De; Milolo, Solange; Meta, Rachel; Esanga, Emmanuel; Vermeiren, Paul Peter; Thys, Séverine; Geertruyden, Jean-Pierre Van; Damme, Pierre Van; Maketa, Vivi; Matangila, Junior; Mitashi, Patrick; Mavoko, Hypolite Muhindo

doi:10.1016/j.vaccine.2022.04.094

Cited by 8 publications

(6 citation statements)

References 36 publications

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“…This action and outreach are necessary to mitigate the spread of false information, allowing citizens to make informed decisions about the outbreaks and clinical vaccine trials. Higher participation in the Ebola vaccine clinical trials could ultimately lead to stronger research outcomes, increased vaccination rates among citizens, and fewer adverse health outcomes in the population 106 . Moreover, affordable internet access needs to be implemented to improve the dissemination of public health information about outbreaks and ongoing vaccine updates.…”

Section: Sustainable Recommendationsmentioning

confidence: 99%

Inequitable access to Ebola vaccines and the resurgence of Ebola in Africa: A state of arts review

Abdul‐Rahman,

Lawal,

Meale

et al. 2023

Journal of Medical Virology

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The Ebola virus, a member of the filoviridae family of viruses, is responsible for causing Ebola Virus Disease (EVD) with a case fatality rate as high as 50%. The largest EVD outbreak was recorded in West Africa from March 2013 to June 2016, leading to over 28 000 cases and 11 000 deaths. It affected several countries, including Nigeria, Senegal, Guinea, Liberia, and Sierra Leone. Until then, EVD was predominantly reported in remote villages in central and west Africa close to tropical rainforests. Human mobility, behavioral and cultural norms, the use of bushmeat, burial customs, preference for traditional remedies and treatments, and resistance to health interventions are just a few of the social factors that considerably aid and amplify the risk of transmission. The scale and persistence of recent ebola outbreaks, as well as the risk of widespread global transmission and its ability for bioterrorism, have led to a rethinking of public health strategies to curb the disease, such as the expedition of Ebola vaccine production. However, as vaccine production lags in the subcontinent, among other challenges, the risk of another ebola outbreak is likely and feared by public health authorities in the region. This review describes the inequality of vaccine production in Africa and the resurgence of EVD, emphasizing the significance of health equality.

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Section: Sustainable Recommendationsmentioning

confidence: 99%

Inequitable access to Ebola vaccines and the resurgence of Ebola in Africa: A state of arts review

Abdul‐Rahman,

Lawal,

Meale

et al. 2023

Journal of Medical Virology

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“…Local political and health authorities were involved, as well as representatives of the civil society, non-governmental organizations and potential participants. Additionally, the study team consulted and collaborated with the local health authorities to help anticipate the potential impacts of the trial activities on the HCPs' duties in the community (Zola Matuvanga et al, 2022).…”

Section: The Vaccine Study and Contextmentioning

confidence: 99%

“…The area, intersected by the majestic Tshuapa river, is characterized by poor road infrastructure and a lack of public transport for moving through the dense tropical forest. Many trial participants had to travel long distances to reach the study site, with dugout canoes and motorcycles as the most common and affordable means of transport at their disposal (Zola Matuvanga et al, 2022). To compensate the participants for participation in the research fairly, financial reimbursement was foreseen to cover time spent and travel expenses.…”

Section: Traffic Accidentsmentioning

confidence: 99%

“…To compensate the participants for participation in the research fairly, financial reimbursement was foreseen to cover time spent and travel expenses. The amounts had been discussed with local health authorities and community representatives, and were approved by the Comité National d’Ethique de la Santé – the EC appointed by the Ministry of Public Health in DRC (Saleh et al, 2020; Zola Matuvanga et al, 2022). Given the geographic and logistical circumstances, it is perhaps not surprising that three participants had been involved in motorcycle accidents, with medical consequences and the need for care.…”

Section: Traffic Accidentsmentioning

confidence: 99%

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Researchers’ responsibilities in resource-constrained settings: experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo

Lemey,

Zola,

Larivière

et al. 2023

Research Ethics

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In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants’ health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers’ well-intentioned AC approach and the participants’ legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made.

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“…Vaccination strategies define a population’s immune protection over time and have the potential to promote equity (e.g., prioritizing the highest-risk groups). The complex sociocultural and political context in which EBOV outbreaks emerge points to the importance of community engagement, effective communication, and building trust to successfully implement control measures [ 107 , 108 , 109 ].…”

Section: Model Subsystemsmentioning

confidence: 99%

Modeling Supply and Demand Dynamics of Vaccines against Epidemic-Prone Pathogens: Case Study of Ebola Virus Disease

Guttieres,

Diepvens,

Decouttere

et al. 2023

Vaccines

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Health emergencies caused by epidemic-prone pathogens (EPPs) have increased exponentially in recent decades. Although vaccines have proven beneficial, they are unavailable for many pathogens. Furthermore, achieving timely and equitable access to vaccines against EPPs is not trivial. It requires decision-makers to capture numerous interrelated factors across temporal and spatial scales, with significant uncertainties, variability, delays, and feedback loops that give rise to dynamic and unexpected behavior. Therefore, despite progress in filling R&D gaps, the path to licensure and the long-term viability of vaccines against EPPs continues to be unclear. This paper presents a quantitative system dynamics modeling framework to evaluate the long-term sustainability of vaccine supply under different vaccination strategies. Data from both literature and 50 expert interviews are used to model the supply and demand of a prototypical Ebolavirus Zaire (EBOV) vaccine. Specifically, the case study evaluates dynamics associated with proactive vaccination ahead of an outbreak of similar magnitude as the 2018–2020 epidemic in North Kivu, Democratic Republic of the Congo. The scenarios presented demonstrate how uncertainties (e.g., duration of vaccine-induced protection) and design criteria (e.g., priority geographies and groups, target coverage, frequency of boosters) lead to important tradeoffs across policy aims, public health outcomes, and feasibility (e.g., technical, operational, financial). With sufficient context and data, the framework provides a foundation to apply the model to a broad range of additional geographies and priority pathogens. Furthermore, the ability to identify leverage points for long-term preparedness offers directions for further research.

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Setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned

Cited by 8 publications

References 36 publications

Inequitable access to Ebola vaccines and the resurgence of Ebola in Africa: A state of arts review

Inequitable access to Ebola vaccines and the resurgence of Ebola in Africa: A state of arts review

Researchers’ responsibilities in resource-constrained settings: experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo

Modeling Supply and Demand Dynamics of Vaccines against Epidemic-Prone Pathogens: Case Study of Ebola Virus Disease

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