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Being Pregnant during the Kivu Ebola Virus Outbreak in DR Congo: The rVSV-ZEBOV Vaccine and Its Accessibility by Mothers and Infants during Humanitarian Crises and in Conflict Areas.

ABSTRACT: The Ebola virus disease (EVD) outbreak that began in Kivu province of the Democratic Republic of the Congo (DRC) in July 2018 is the second largest in history. It is also the largest and most deadly of the ten Ebola outbreaks to occur in DRC, the country where Ebola was first identified during the 1976 Yambuku outbreak. The Kivu region is one of the most challenging locations in which to organize humanitarian assistance. It is an active conflict zone in which numerous armed groups are conducting violent acts, often directed against the inhabitants, healthcare and relief workers and peacekeepers. EVD has been especially problematic in pregnancy-previous outbreaks both in DRC and other countries have resulted in very high mortality rates among pregnant women and especially their infants, with maternal mortality in some outbreaks reaching over 90% and perinatal mortality 100%. The development and implementation of the Merck rVSV-ZEBOV vaccine for Ebola infection has been a tremendous public health advance in preventing EVD, being used successfully in both the West Africa Ebola epidemic and the Équateur DRC Ebola outbreak. But from the start of the Kivu outbreak, policy decisions had resulted in excluding pregnant and lactating women and their infants from receiving it during extensive ring vaccination efforts. In June 2019, this policy was reversed, 10 months after the start of the outbreak. Pregnant and lactating women are now permitted not only the rVSV-ZEBOV vaccine in the continuing Kivu outbreak but also the newly implemented Ad26.ZEBOV/MVA-BN vaccine.

SUBMITTER: Schwartz DA

PROVIDER: S-EPMC7157486 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Being Pregnant during the Kivu Ebola Virus Outbreak in DR Congo: The rVSV-ZEBOV Vaccine and Its Accessibility by Mothers and Infants during Humanitarian Crises and in Conflict Areas.

Schwartz David A DA

Vaccines 20200122 1

The Ebola virus disease (EVD) outbreak that began in Kivu province of the Democratic Republic of the Congo (DRC) in July 2018 is the second largest in history. It is also the largest and most deadly of the ten Ebola outbreaks to occur in DRC, the country where Ebola was first identified during the 1976 Yambuku outbreak. The Kivu region is one of the most challenging locations in which to organize humanitarian assistance. It is an active conflict zone in which numerous armed groups are conducting ...[more]

PMID: 31979026

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Project description:BackgroundThe recent West African Ebola epidemic led to accelerated efforts to test Ebola vaccine candidates. As part of the World Health Organisation-led VSV Ebola Consortium (VEBCON), we performed a phase I clinical trial investigating rVSV-ZEBOV (a recombinant vesicular stomatitis virus-vectored Ebola vaccine), which has recently demonstrated protection from Ebola virus disease (EVD) in phase III clinical trials and is currently in advanced stages of licensing. So far, correlates of immune protection are incompletely understood and the role of cell-mediated immune responses has not been comprehensively investigated to date.MethodsWe recruited 30 healthy subjects aged 18-55 into an open-label, dose-escalation phase I trial testing three doses of rVSV-ZEBOV (3×105 plaque-forming units (PFU), 3×106 PFU, 2×107 PFU) (ClinicalTrials.gov; NCT02283099). Main study objectives were safety and immunogenicity, while exploratory objectives included lymphocyte dynamics, cell-mediated immunity and cytokine networks, which were assessed using flow cytometry, ELISpot and LUMINEX assay.FindingsImmunization with rVSV-ZEBOV was well tolerated without serious vaccine-related adverse events. Ebola virus-specific neutralizing antibodies were induced in nearly all individuals. Additionally, vaccinees, particularly within the highest dose cohort, generated Ebola glycoprotein (GP)-specific T cells and initiated a cascade of signaling molecules following stimulation of peripheral blood mononuclear cells with Ebola GP peptides.InterpretationIn addition to a benign safety and robust humoral immunogenicity profile, subjects immunized with 2×107 PFU elicited higher cellular immune responses and stronger interlocked cytokine networks compared to lower dose groups. To our knowledge these data represent the first detailed cell-mediated immuneprofile of a clinical trial testing rVSV-ZEBOV, which is of particular interest in light of its potential upcoming licensure as the first Ebola vaccine. VEBCON trial Hamburg, Germany (NCT02283099).

Project description:Background:Insecurity has characterized the Eastern regions of the Democratic Republic of Congo for decades. Providing health services to sustain women's and children's health during protracted conflict is challenging. This mixed-methods case study aimed to describe how reproductive, maternal, newborn, child, adolescent health and nutrition (RMNCAH+N) services have been offered in North and South Kivu since 2000 and how successful they were. Methods:We conducted a case study using a desk review of publicly available literature, secondary analysis of survey and health information system data, and primary qualitative interviews. The qualitative component provides insights on factors shaping RMNCAH+N design and implementation. We conducted 49 interviews with government officials, humanitarian agency staff and facility-based healthcare providers, and focus group discussions with community health workers in four health zones (Minova, Walungu, Ruanguba, Mweso). We applied framework analysis to investigate key themes across informants.The quantitative component used secondary data from nationwide surveys and the national health facility information system to estimate coverage of RMNCAH+N interventions at provincial and sub-provincial level. The association between insecurity on service provision was examined with random effects generalized least square models using health facility data from South Kivu. Results:Coverage of selected preventive RMNCAH+N interventions seems high in North and South Kivu, often higher than the national level. Health facility data show a small negative association of insecurity and preventive service coverage within provinces. However, health outcomes are poorer in conflict-affected territories than in stable ones. The main challenges to service provisions identified by study respondents are the availability and retention of skilled personnel, the lack of basic materials and equipment as well as the insufficient financial resources to ensure health workers' regular payment, medicaments' availability and facilities' running costs. Insecurity exacerbates pre-existing challenges, but do not seem to represent the main barrier to service provision in North and South Kivu. Conclusions:Provision of preventive schedulable RMNCAH+N services has continued during intermittent conflict in North and South Kivu. The prolonged effort by non-governmental organizations and UN agencies to respond to humanitarian needs was likely key in maintaining intervention coverage despite conflict. Health actors and communities appear to have adapted to changing levels and nature of insecurity and developed strategies to ensure preventive services are provided and accessed. However, emergency non-schedulable RMNCAH+N interventions do not appear to be readily accessible. Achieving the Sustainable Development Goals will require increased access to life-saving interventions, especially for newborn and pregnant women.

Project description:BackgroundIn conflict-affected settings, data on reproductive, maternal, newborn and child health (RMNCH) are often lacking for priority setting and timely decision-making. We aimed to describe the levels and trends in RMNCH indicators within Kivu provinces between 2015 and 2018, by linking conflict data with health facility (HF) data from the District Health Information System 2 (DHIS2).MethodsWe used data from the DHIS2 for the period 2015-2018, the 2014 Demographic and Health Survey, the 2018 Multiple Indicators Cluster Survey and the Uppsala Conflict Data Program. Health zones were categorised in low, moderate and high conflict intensity level, based on an annual conflict death rate. We additionally defined a monthly conflict death rate and a conflict event-days rate as measures of conflict intensity and insecurity. Outcomes were completion of four antenatal care visits, health facility deliveries, caesarean sections and pentavalent vaccine coverage. We assessed data quality and analyzed coverage and trends in RMNCH indicators graphically, by conflict categories and using HF data aggregated annually. We used a series of fixed-effect regression models to examine the potential dose-response effect of varying conflict intensity and insecurity on RMNCH.ResultsThe overall HF reporting was good, ranging between 83.3 and 93.2% and tending to be lower in health zones with high conflict intensity in 2016 and 2017 before converging in 2018. Despite the increasing number of conflict-affected health zones over time, more in North-Kivu than in South-Kivu, we could not identify any clear pattern of variation in RMNCH coverage both by conflict intensity and insecurity. North-Kivu province had consistently reported better RMNCH indicators than South-Kivu, despite being more affected by conflict. The Kivu as a whole recorded higher coverage than the national level. Coverage of RMNCH services calculated from HF data was consistent with population-based surveys, despite year-to-year fluctuation among health zones and across conflict-intensity categories.ConclusionsAlthough good in general, the HF reporting rate in the Kivu was negatively impacted by conflict intensity especially at the beginning of the DHIS2's rolling-up. Routine HF data appeared useful for assessing and monitoring trends in RMNCH service coverage, including in areas with high-intensity conflict.

Project description:BackgroundYoung people including adolescents face barriers to healthcare and increased risk of poor sexual and reproductive health (SRH), which are exacerbated in humanitarian settings. Our systematic review assessed the evidence on SRH interventions for young people including adolescents in humanitarian settings, strategies to increase their utilisation and their effects on health outcomes.MethodsWe searched peer-reviewed and grey literature published between 1980 and 2018 using search terms for adolescents, young people, humanitarian crises in low- and middle- income countries and SRH in four databases and relevant websites. We analysed literature matching pre-defined inclusion criteria using narrative synthesis methodology, and appraised for study quality.FindingsWe found nine peer-reviewed and five grey literature articles, the majority published post-2012 and mostly high- or medium-quality, focusing on prevention of unintended pregnancies, HIV/STIs, maternal and newborn health, and prevention of sexual and gender-based violence. We found no studies on prevention of mother-to-child transmission (PMTCT), safe abortion, post-abortion care, urogenital fistulae or female genital mutilation (FGM). Thirteen studies reported positive effects on outcomes (majority were positive changes in knowledge and attitudes), seven studies reported no effects in some SRH outcomes measured, and one study reported a decrease in number of new and repeat FP clients. Strategies to increase intervention utilisation by young people include adolescent-friendly spaces, peer workers, school-based activities, and involving young people.DiscussionYoung people, including adolescents, continue to be a neglected group in humanitarian settings. While we found evidence that some SRH interventions for young people are being implemented, there are insufficient details of specific intervention components and outcome measurements to adequately map these interventions. Efforts to address this key population's SRH needs and evaluate effective implementation modalities require urgent attention. Specifically, greater quantity and quality of evidence on programmatic implementation of these interventions are needed, especially for comprehensive abortion care, PMTCT, urogenital fistulae, FGM, and for LGBTQI populations and persons with disabilities. If embedded within a broader SRH programme, implementers and/or researchers should include young people-specific strategies, targeted at both girls/women and boys/men where appropriate, and collect age- and sex-disaggregated data to help ascertain if this population's diverse needs are being addressed.

Project description:Sexual violence is highly prevalent in armed conflict and other humanitarian crises and attracting increasing policy and practice attention. This systematic review aimed to canvas the extent and impact of initiatives to reduce incidence, risk and harm from sexual violence in conflict, post-conflict and other humanitarian crises, in low and middle income countries. Twenty three bibliographic databases and 26 websites were searched, covering publications from 1990 to September 2011 using database-specific keywords for sexual violence and conflict or humanitarian crisis. The 40 included studies reported on seven strategy types: i) survivor care; ii) livelihood initiatives; iii) community mobilisation; iv) personnel initiatives; v) systems and security responses; vi) legal interventions and vii) multiple component interventions. Conducted in 26 countries, the majority of interventions were offered in African countries. Despite the extensive literature on sexual violence by combatants, most interventions addressed opportunistic forms of sexual violence committed in post-conflict settings. Only one study specifically addressed the disaster setting. Actual implementation of initiatives appeared to be limited as was the quality of outcome studies. No studies prospectively measured incidence of sexual violence, although three studies provided some evidence of reductions in association with firewood distribution to reduce women's exposure, as did one program to prevent sexual exploitation and abuse by peacekeeping forces. Apparent increases to risk resulted from lack of protection, stigma and retaliation associated with interventions. Multiple-component interventions and sensitive community engagement appeared to contribute to positive outcomes. Significant obstacles prevent women seeking help following sexual violence, pointing to the need to protect anonymity and preventive strategies. This review contributes a conceptual framework for understanding the forms, settings, and interventions for conflict and crisis-related sexual violence. It points to the need for thorough implementation of initiatives that build on local capacity, while avoiding increased risk and re-traumatisation to survivors of sexual violence.

Dataset Information

Being Pregnant during the Kivu Ebola Virus Outbreak in DR Congo: The rVSV-ZEBOV Vaccine and Its Accessibility by Mothers and Infants during Humanitarian Crises and in Conflict Areas.

Publications

Being Pregnant during the Kivu Ebola Virus Outbreak in DR Congo: The rVSV-ZEBOV Vaccine and Its Accessibility by Mothers and Infants during Humanitarian Crises and in Conflict Areas.

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