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

CEPI launches 100-day vaccine “moonshot”

The Coalition for Epidemic Preparedness Innovations (CEPI) was formed in the aftermath of the 2014–2015 Ebola outbreak in west Africa to support the development of vaccines that could improve the world’s preparedness against outbreaks of epidemic infectious diseases. Since its launch in 2017, CEPI has mobilized more than US$750 million to support its mission to develop vaccines against agents such as Lassa virus, Middle East respiratory syndrome coronavirus, and Nipah virus, as well as several rapid-response vaccine platforms to accelerate response times to unexpected epidemic threats. CEPI has also played a leading role in fostering institutional partnerships between public- and private-sector organizations to optimize allocation of resources for vaccine development against its priority pathogens. CEPI’s priorities include diversification of its current vaccine research and development investment portfolio to include additional pathogens, such as Rift Valley fever and chikungunya; establishment of technical and regulatory pathways for vaccine development across CEPI’s portfolio; development of sustainable manufacturing solutions for vaccine candidates nearing completion of safety and immunogenicity testing in humans; and creation of investigational stockpiles of its vaccine candidates for use in emergency situations. This commentary provides an overview of the global health challenges CEPI was established to address and its achievements to date, and indicates priorities for funding and coordination in the coming years.

WHO meeting chooses untried interventions to defeat Ebola

Ensuring global access to COVID-19 vaccines

PurposeAs cancer burden has risen worldwide, physicians, patients, and their advocates have become aware that the clinical cancer trial research paradigm is not ubiquitous. Furthermore, the number and characteristics of trials that are registered in low- and middle-income countries (LMICs) compared with that in high-income countries (HICs) are unknown.MethodsWe collected retrospective data on trials for breast, lung, and cervical cancer registered in ClinicalTrials.gov or with the WHO International Clinical Trial Registry Platform between 2010 and 2017. The data were then classified as trials within LMICs or HICs using definitions from the World Bank.ResultsIncluded in these analyses were 6,710 trials, of which 3,164 (47%) were breast cancer trials, 3,283 (49%) were lung cancer trials, and 263 (4%) were cervical cancer trials. There were 1,951 (29%) trials from LMICs and 4,759 (71%) trials from HICs (P < .001). Although the proportion of phase III trials in HICs versus LMICs was similar (18% v 17%; P = .66), the number of phase I trials in LMICs was significantly lower than that of HICs (20% v 2%; P < .001). For several LMICs with the highest mortality-to-incidence ratios for breast, lung, or cervical cancer, there were no cancer trials registered in the registration data bases searched for this work.ConclusionThere are differences in access to cancer clinical trials in LMICs compared with HICs. Several factors, such as excessive cost and a lack of infrastructure and expertise, may explain these differences.

Ebola in west Africa: learning the lessons

Clinical trials represent the gold standard to test the safety and efficacy of new or updated approaches to treatments that will inform quality cancer care. However, cancer trials enroll few patients in low- and middle-income countries (LMICs), are often led by investigators from high-income countries, and do not adequately reflect global disease burden or population diversity. To identify key challenges and strategies to advance contextually relevant, quality cancer trials in LMICs. The survey used in this survey study was available in English, Arabic, French, Portuguese, and Spanish and was conducted by the US National Cancer Institute from October 18 to December 22, 2023. Clinicians with experience in cancer therapeutic clinical trials in LMICs were eligible. The survey covered their professional background and views on challenges and strategies for improving clinical trial opportunities in LMICs. Analysis was performed from April 2 to August 26, 2024. Respondents were asked to rate 34 challenges by impact on their ability to conduct cancer trials using a 4-point Likert scale and 8 strategies by importance using a 5-point Likert scale. Descriptive statistics summarized participants' backgrounds, challenges, and priorities. Of 453 respondents who began the survey, a total of 223 (49%) were eligible for inclusion, and 131 of those (59%) completed the survey in full. Among the 133 respondents who provided gender data, 81 (61%) were male. In all, 107 of 130 respondents (82%) were affiliated with LMIC institutions, 65 of 223 (29%) were medical oncologists, and 52 of 133 (39%) were midcareer. Financial challenges were rated as the most impactful, with 133 of 170 respondents (78%) rating difficulty obtaining funding for investigator-initiated trials as having a large impact on ability to carry out a trial. Human capacity issues followed, with 105 of 192 respondents (55%) rating lack of dedicated research time as having a large impact. Increasing opportunities for funding and improving human capacity were reported as key strategies to advance capacity to conduct clinical trials in LMICs. This survey study of clinicians with clinical trial experience in LMICs suggests that adequate funding and a well-trained research workforce are 2 predominant challenges to advancing cancer therapeutic clinical trials in LMICs. Understanding these obstacles can inform efforts to support cancer clinical trials that better reflect worldwide needs and diversity by prioritizing and sustaining research led by LMIC investigators.

The ethics of global clinical trials: In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disadvantaged populations?

Global coalition to accelerate COVID-19 clinical research in resource-limited settings

Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices.

Evaluation of the National Institute for Health and Care Research’s (NIHR) Global Health Research (GHR) Portfolio - Inception Report

ABSTRACTResearchers reflect on sociocultural aspects of the Ebola outbreak in West Africa and critically analyze the epidemic's effects on pregnant mothers and their babies. We address structural inequalities contributing to poor maternal health in lower-income countries, while reflecting on how the Ebola outbreak highlights the still-marginalized role of pregnant women. Drawing on prior research in West and East Africa, we discuss health care providers’ responses to risk of infection during maternity work under normal circumstances and in times of crisis. We end with recommendations for preventing such detrimental effects on the health of pregnant women in the case of another epidemic.

ABSTRACTIn the pursuit of ‘global health security’, some governments advocate deployment of pharmaceuticals to combat deadly infectious diseases wherever they emerge. Following the Ebola outbreak in West Africa, attention has turned to other emerging diseases and future pharmaceutical solutions. There is growing support for enabling faster clinical research to make new vaccines available sooner. Research on experimental vaccines must ordinarily be consistent with ethical principles designed to protect human research participants. However, where a target disease is framed in security terms, it could be argued that an extraordinary response is required: exposing research participants to more risk in order to accelerate research and enable more lives to be saved pharmaceutically. This article assesses two scenarios of security-oriented research. The scenario envisaged by the Coalition for Epidemic Preparedness Innovations (CEPI) is the propelling of vaccine research through to the stage of human safety-testing before a natural outbreak of the relevant disease. Efficacy and effectiveness tests are then able to be conducted once an outbreak begins. In a hypothetical second scenario, pre-outbreak vaccine research undertaken for the sake of health security would also include efficacy-testing. This would involve the exposure to pathogenic microorganisms of healthy volunteers (‘global bioheroes’) from around the world.

According to the US Centers for Disease Control and Prevention, the 2014 Ebola outbreak in West Africa is the largest Ebola outbreak in history and the first to be classified as an epidemic. This article reviews the clinical characteristics of patients infected with Ebola, as well as reviews the global response in tracking and managing the outbreak and provided an overview of potential therapeutic options.

Introduction: Lassa fever (LF) remains a continuing public health threat across West Africa, where many clinical trial sites lack sufficient community engagement (CE) capacity to support ethical, effective vaccine research. In response, the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Advancing Research Capacity in West Africa (ARC-WA) initiative, led by the Technical Coordinating Partners (TCP), aims to build CE capacity and a sustained platform for readiness to support a Phase 2b efficacy trial and future epidemic-responsive research. To build sustainable CE capacity at selected clinical trial sites in West Africa by supporting SOP development, targeted training, and implementing participatory community engagement strategies aligned with Good Participatory Practice (GPP) standards. Methods: A multi-site intervention is being implemented at six clinical trial research centers in Lassa Fever-endemic countries. Key activities include: development of CE SOPs (e.g., stakeholder mapping, community advisory board (CAB) management, community sensitization); conducting site-level training workshops; facilitating participatory planning sessions; and integrating CE tools into broader trial preparedness activities. Participants include CE focal staff, CAB members, and clinical site leadership. Results: Preliminary findings indicate improved comprehension of CE principles among site teams, development and piloting of CE SOPs at four sites, and enhanced engagement with local stakeholders. All the sites have initiated CE planning aligned with recruitment and retention and broader trial preparedness goals. Final documentation and analysis are ongoing, with full results expected by Q2 2025. Conclusion: Investing in CE capacity contributes to more agile, ethical, and community-responsive vaccine trial sites. While the initiative is rooted in LF preparedness, the tools and strategies developed are broadly applicable to other priority pathogen trials. These effort supports CEPI’s 100 Day Mission and demonstrates scalable, sustainable practices for public health emergency preparedness in the region.