LogoLogoMSF Science Portal
  • My saved items
logo

© Médecins Sans Frontières

MSF Science Portal
About MSF Science Portal
About MSF
Contact Us
Frequently Asked Questions (FAQs)
Privacy Policy
Terms of Use

v2.1.4829.produseast1

17 result(s)
Filter and sort
17 result(s)
Journal Article > ResearchFull Text

Using an analogue-digital hybrid clinical data management platform during a two-dose preventive Ebola virus vaccine trial in Goma, the Democratic Republic of the Congo

PLOS Glob Public Health. 2 May 2025; Volume 5 (Issue 5); e0004487.; DOI:10.1371/journal.pgph.0004487
Brindle HE, Tetsa-Tata D, Edwards T, Choi EML, Kasonia K,  et al.
PLOS Glob Public Health. 2 May 2025; Volume 5 (Issue 5); e0004487.; DOI:10.1371/journal.pgph.0004487

Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45–64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings.

More
Journal Article > ResearchFull Text

Pregnancy and neonatal outcomes in Eastern Democratic Republic of the Congo: a systematic review

Front Glob Womens Health. 5 December 2024; Volume 5; 1412403.; DOI:10.3389/fgwh.2024.1412403
Kasonia K, Brindle H, Manno D, Edwards T, Gardais S,  et al.
Front Glob Womens Health. 5 December 2024; Volume 5; 1412403.; DOI:10.3389/fgwh.2024.1412403

BACKGROUND

Conflict is known to impact maternal and neonatal health in Eastern Democratic Republic of the Congo (DRC), an area of longstanding insecurity. We conducted a systematic review on pregnancy and neonatal outcomes in this region to provide a comprehensive overview of maternal and neonatal outcomes over a 20-year period.


METHODS

We systematically searched databases, such as Medline, EMBASE, Global Health, ClinicalTrials.gov and the Cochrane Library, along with grey literature, for articles published between 2001 and 2021. These articles provided quantitative data on selected pregnancy and neonatal outcomes in the provinces of Ituri, Maniema and North and South Kivu, Eastern DRC. We conducted a descriptive analysis, combining results from different data sources and comparing incidence of outcomes in North Kivu with those in other provinces in Eastern DRC.


RESULTS

A total of 1,065 abstracts from peer-reviewed publications and 196 articles from the grey literature were screened, resulting in the inclusion of 14 scientific articles in the review. The most frequently reported pregnancy complications were caesarean sections (11.6%–48.3% of deliveries) and miscarriage (1.2%–30.0% of deliveries). The most common neonatal outcomes were low birth weight (3.8%–21.9% of live births), preterm birth (0.9%–74.0%) and neonatal death (0.2%–43.3%).


CONCLUSION

Our review provides data on pregnancy and neonatal outcomes in Eastern DRC, which will be valuable for future studies. Despite the area's ongoing armed conflict, the percentages of complications we noted in Eastern DRC are comparable with those observed in other countries in the region.

More
Journal Article > ResearchFull Text

Immunogenicity of an extended dose interval for the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen in adults and children in the Democratic Republic of the Congo

Vaccines. 26 July 2024; Volume 12 (Issue 8); 828.; DOI:10.3390/vaccines12080828
Choi EM, Kasonia K, Kavunga-Membo H, Mukadi-Bamuleka D, Soumah A,  et al.
Vaccines. 26 July 2024; Volume 12 (Issue 8); 828.; DOI:10.3390/vaccines12080828

During the 2018–2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to the COVID-19 pandemic led to some participants receiving a late dose 2 outside the planned interval. Blood samples were collected from adults, adolescents, and children prior to their delayed dose 2 vaccination and 21 days after, and tested for IgG binding antibodies against Ebola virus glycoprotein using the Filovirus Animal Nonclinical Group (FANG) ELISA. Results from 133 participants showed a median two-dose interval of 9.3 months. The pre-dose 2 antibody geometric mean concentration (GMC) was 217 ELISA Units (EU)/mL (95% CI 157; 301) in adults, 378 EU/mL (281; 510) in adolescents, and 558 EU/mL (471; 661) in children. At 21 days post-dose 2, the GMC increased to 22,194 EU/mL (16,726; 29,449) in adults, 37,896 EU/mL (29,985; 47,893) in adolescents, and 34,652 EU/mL (27,906; 43,028) in children. Participants receiving a delayed dose 2 had a higher GMC at 21 days post-dose 2 than those who received a standard 56-day regimen in other African trials, but similar to those who received the regimen with an extended interval.

More
Journal Article > ResearchFull Text

Delivery and safety of a two-dose preventive Ebola virus disease vaccine in pregnant and non-pregnant participants during an outbreak in the Democratic Republic of the Congo

Vaccines. 23 July 2024; Volume 12 (Issue 8); 825.; DOI:10.3390/vaccines12080825
Kavunga-Membo H, Watson-Jones D, Kasonia K, Edwards T, Camacho A,  et al.
Vaccines. 23 July 2024; Volume 12 (Issue 8); 825.; DOI:10.3390/vaccines12080825

During the 2018–2020 Ebola virus disease (EVD) outbreak, residents in Goma, Democratic Republic of the Congo, were offered a two-dose prophylactic EVD vaccine. This was the first study to evaluate the safety of this vaccine in pregnant women. Adults, including pregnant women, and children aged ≥1 year old were offered the Ad26.ZEBOV (day 0; dose 1), MVA-BN-Filo (day 56; dose 2) EVD vaccine through an open-label clinical trial. In total, 20,408 participants, including 6635 (32.5%) children, received dose 1. Fewer than 1% of non-pregnant participants experienced a serious adverse event (SAE) following dose 1; one SAE was possibly related to the Ad26.ZEBOV vaccine. Of the 1221 pregnant women, 371 (30.4%) experienced an SAE, with caesarean section being the most common event. No SAEs in pregnant women were considered related to vaccination. Of 1169 pregnancies with a known outcome, 55 (4.7%) ended in a miscarriage, and 30 (2.6%) in a stillbirth. Eleven (1.0%) live births ended in early neonatal death, and five (0.4%) had a congenital abnormality. Overall, 188/891 (21.1%) were preterm births and 79/1032 (7.6%) had low birth weight. The uptake of the two-dose regimen was high: 15,328/20,408 (75.1%). The vaccine regimen was well-tolerated among the study participants, including pregnant women, although further data, ideally from controlled trials, are needed in this crucial group.

More
Journal Article > Book ChapterFull Text

Building partnerships and confronting challenges: Implementation of an ebola virus vaccine clinical study during an outbreak in the Democratic Republic of the Congo

Nephrol Dial Transplant. 31 December 2023; 173-193.; DOI:10.1007/978-3-031-53793-6_12
Bausch DG, Kavunga-Membo H, Grais RF, Imbault N, Roberts N,  et al.
Nephrol Dial Transplant. 31 December 2023; 173-193.; DOI:10.1007/978-3-031-53793-6_12

Research, especially clinical trials, during outbreaks often poses enormous challenges, and up until very recent times was often considered almost impossible. However, for diseases such as Ebola virus disease, which are seen almost exclusively in outbreak form, outbreaks are the only opportunity to perform studies and accrue knowledge. Here, we discuss our experiences and lessons learned implementing a clinical study of an Ebola virus vaccine during an outbreak of that disease in 2018–20 in eastern Democratic Republic of the Congo. Keys to success is these settings include forging partnerships with diverse and complementary experience and skills, working out clear roles and responsibilities, communicating and engaging with the community as an essential partner, and maintaining flexibility to adapt to unexpected events. Progress in these complex settings requires both quick action to implement studies as soon as possible, coupled with patience, realizing that results often come with a sequential long-term approach across outbreaks as opportunities arise. Despite the many challenges, where the political will is there and the right team assembled, significant progress can be made, contributing both to control of the present outbreak and prevention or enhanced control of the next one.

More
Journal Article > ResearchFull Text

Protection, health seeking, or a laissez-passer: Participants’ decision-making in an EVD vaccine trial in the eastern Democratic Republic of the Congo

Soc. Sci. Med. 15 March 2023; Volume 323; 115833.; DOI:10.1016/j.socscimed.2023.115833
James M, Kasereka JG, Kasiwa B, Kavunga-Membo H, Kambale K,  et al.
Soc. Sci. Med. 15 March 2023; Volume 323; 115833.; DOI:10.1016/j.socscimed.2023.115833
During the 10th Ebola virus disease (EVD) epidemic in the eastern Democratic Republic of the Congo (DRC) (2018-2020), two experimental EVD vaccines were deployed in North Kivu. This province has been at the centre of conflict in the region for the last 25 years. Amidst ambivalence towards protracted foreign intervention and controversy about introducing two experimental vaccines, the existing literature has focused on mistrust and 'resistance' towards the Ebola response and vaccines. In this article, we examine why people in the eastern DRC did decide to volunteer for a trial of a second EVD vaccine in North Kivu, despite the controversy. Drawing on ethnographic observation, interviews, and focus groups with trial participants conducted between September 2020 and April 2021, we analyse three motivations for participating: protection, health seeking, and expectations surrounding travel requirements. We make three points. First, participation in vaccine trials may be understood locally to have advantages which have not been considered by the trial, because they go beyond medical considerations and are specific to a particular social setting. Second, despite much of the literature focusing on a causal relationship between rumours and 'vaccine hesitancy', some rumours may in fact encourage participation. Third, material objects associated with trial participation - such as participant vaccine cards - can hold social and political meaning beyond the confines of the vaccine clinic, and influence decisions surrounding participation. Empirical investigation of how medical interventions become entangled in political economies is essential to understanding the perceived functions of participation, and thus the reasons why people volunteer in clinical trials. Participants' narratives about their decision-making provide an insight into how international bioethical debates interact with, but may also stand apart from, the situated social and economic realities driving decision-making around clinical trials on the ground. This highlights the need for ethical approaches that foreground the political, social, and economic context.More
Journal Article > ResearchFull Text

Ebola Virus Disease in pregnancy: clinical, histopathologic and Immunohistochemical findings

J Infect Dis. 25 May 2016; Volume 215 (Issue 1); 64–69.; DOI:10.1093/infdis/jiw206
Muehlenbachs A, de la Rosa Vazquez O, Bausch DG, Schafer IJ, Paddock C,  et al.
J Infect Dis. 25 May 2016; Volume 215 (Issue 1); 64–69.; DOI:10.1093/infdis/jiw206
Here we describe clinicopathologic features of EVD in pregnancy. One woman infected with Sudan virus in Gulu, Uganda in 2000 had a stillbirth and survived, and another woman with Bundibugyo virus had a livebirth with maternal and infant death in Isiro, the Democratic Republic of the Congo in 2012. Ebolavirus antigen was seen in the syncytiotrophoblast and placental maternal mononuclear cells by immunohistochemistry, and no antigen was seen in fetal placental stromal cells or fetal organs. In the Gulu case, ebolavirus antigen localized to malaria pigment-laden macrophages. These data suggest trophoblast infection may be a mechanism of transplacental ebolavirus transmission.More
Journal Article > ResearchFull Text

A standardised phase III clinical trial framework to assess therapeutic interventions for Lassa fever

PLoS Negl Trop Dis. 6 January 2022; Volume 16 (Issue 1); E0010089.; DOI:10.1371/journal.pntd.0010089
Olayinka A, Bourner J, Akpede GO, Okoeguale J, Abejegah C,  et al.
PLoS Negl Trop Dis. 6 January 2022; Volume 16 (Issue 1); E0010089.; DOI:10.1371/journal.pntd.0010089
BACKGROUND
Only one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago-the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence.

METHODOLOGY
We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology.

RESULTS
A consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols.

CONCLUSIONS
This project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level.
More
Journal Article > ReviewFull Text

Essentials of Filoviral Load Quantification

Lancet Infect Dis. 10 June 2016; Volume 16 (Issue 7); DOI:10.1016/S1473-3099(16)30063-9
Cnops L, van Griensven J, Honko AN, Bausch DG, Sprecher A,  et al.
Lancet Infect Dis. 10 June 2016; Volume 16 (Issue 7); DOI:10.1016/S1473-3099(16)30063-9
Quantitative measurement of viral load is an important parameter in the management of filovirus disease outbreaks because viral load correlates with severity of disease, survival, and infectivity. During the ongoing Ebola virus disease outbreak in parts of Western Africa, most assays used in the detection of Ebola virus disease by more than 44 diagnostic laboratories yielded qualitative results. Regulatory hurdles involved in validating quantitative assays and the urgent need for a rapid Ebola virus disease diagnosis precluded development of validated quantitative assays during the outbreak. Because of sparse quantitative data obtained from these outbreaks, opportunities for study of correlations between patient outcome, changes in viral load during the course of an outbreak, disease course in asymptomatic individuals, and the potential for virus transmission between infected patients and contacts have been limited. We strongly urge the continued development of quantitative viral load assays to carefully evaluate these parameters in future outbreaks of filovirus disease.More
Journal Article > CommentaryFull Text

Overlooking the Importance of Immunoassays - Authors' Reply

Lancet Infect Dis. 19 September 2016; Volume 16 (Issue 10); DOI:10.1016/S1473-3099(16)30339-5
Cnops L, van Griensven J, Honko AN, Bausch DG, Sprecher A,  et al.
Lancet Infect Dis. 19 September 2016; Volume 16 (Issue 10); DOI:10.1016/S1473-3099(16)30339-5