Engaging the public in decisions about emergency vaccine deployment strategies: Lessons from scenario-based discussions in Sierra Leone.

ABSTRACTThe COVID-19 pandemic has amplified discussions on emergency vaccine deployment strategies, with current perspectives often neglecting extensive community involvement in ethical, logistical and political aspects. Existing social science literature predominantly delves into factors influencing trust, overlooking the untapped potential for community engagement.Our study examines community preparedness in Sierra Leone's Kambia District, exploring diverse viewpoints on vaccine deployment strategies, emphasising Ebola and COVID-19 vaccinations. Utilising extensive ethnographic research from the Ebola vaccine trials (EBOVAC Salone) conducted in Kambia District from 2015 to 2021, including participant observation and tailored focus group discussions, we investigated various deployment scenarios with community leaders and citizens.Our findings underscore the multifaceted contributions of social science research with communities in shaping emergency vaccination strategies. These contributions span logistical insights, aligning campaigns with local livelihoods and social structures, and grounded ethical concerns assessing social justice outcomes across epidemic scenarios. This study emphasises the imperative of integrating discussions on vaccine confidence and deployment. It highlights communities' proficiency in epidemiological reasoning and their ability to bring this in conversation with salient socio-cultural, economic and religious dimensions. We therefore promote the cultivation of public dialogue, collaborative creation of impactful vaccination initiatives alongside relevant communities in recognition of their invaluable perspectives .

Pathways to reduced physical intimate partner violence among women in north-western Tanzania: Evidence from two cluster randomised trials of the MAISHA intervention.

Intimate partner violence (IPV) affects over one-in-four women globally. Combined economic and social empowerment interventions are a promising IPV prevention model. However, questions remain on the mechanisms through which such interventions prevent IPV, and whether standalone social empowerment interventions can work in the absence of an economic component. This secondary analysis of MAISHA Study data (north-western Tanzania) explores pathways through which a group-based gender-training intervention, delivered to women standalone or alongside microfinance, may impact on physical IPV risk. Two cluster-randomised trials (CRT) assessed the impact of the MAISHA intervention on women's IPV risk; CRT01 among women in 66 pre-existing microfinance groups (n = 919), and CRT02 among 66 newly-formed groups not receiving microfinance (n = 1125). Women were surveyed at baseline and 29 months follow-up. Sub-group analyses explored whether intervention effects on past-year experience of physical IPV varied by participant characteristics. Mediators of intervention effect on physical IPV were explored using mixed-effects logistic regression (disaggregated by trial). In CRT01, MAISHA was associated with reduced past-year physical IPV (adjusted-OR 0.63, 95%CI 0.41-0.98), with stronger effects among those younger, more financially independent, and without prior physical IPV. CRT02 showed no impact on physical IPV, overall or among sub-groups. In CRT01, individual-level reduced acceptability of IPV and group-level confidence to intervene against IPV emerged as potential mediators of intervention effect, while relationship-level indicators of communication were not impacted. In CRT02, positive impacts on individual-level attitudes did not translate into reduced IPV risk. In CRT02, arguments with partners over perceived transgressions of gender roles increased in the intervention-arm. Neither trial resulted in increased separations. Findings illustrate the importance of addressing poverty and women's economic dependence on men, structural factors that may impede the success of socially oriented violence prevention programming. Programming with men is also crucial to ameliorate risks of backlash against attitudinal/behavioural change among women. Trial registration: ClinicalTrials.gov #NCT02592252.

A rapid qualitative methods assessment and reporting tool for epidemic response as the outcome of a rapid review and expert consultation.

During the first year of the COVID-19 pandemic, the Methods Sub-Group of the WHO COVID-19 Social Science Research Roadmap Working Group conducted a rapid evidence review of rapid qualitative methods (RQMs) used during epidemics. The rapid review objectives were to (1) synthesize the development, implementation, and uses of RQMs, including the data collection tools, research questions, research capacities, analytical approaches, and strategies used to speed up data collection and analysis in their specific epidemic and institutional contexts; and (2) propose a tool for assessing and reporting RQMs in epidemics emergencies. The rapid review covered published RQMs used in articles and unpublished reports produced between 2015 and 2021 in five languages (English, Mandarin, French, Portuguese, and Spanish). We searched multiple databases in these five languages between December 2020 and January 31, 2021. Sources employing "rapid" (under 6 months from conception to reporting of results) qualitative methods for research related to epidemic emergencies were included. We included 126 published and unpublished sources, which were reviewed, coded, and classified by the research team. Intercoder reliability was found to be acceptable (Krippendorff's α = 0.709). We employed thematic analysis to identify categories characterizing RQMs in epidemic emergencies. The review protocol was registered at PROSPERO (no. CRD42020223283) and Research Registry (no. reviewregistry1044). We developed an assessment and reporting tool of 13 criteria in three domains, to document RQMs used in response to epidemic emergencies. These include I. Design and Development (i. time frame, ii. Training, iii. Applicability to other populations, iv. Applicability to low resource settings, v. community engagement, vi. Available resources, vii. Ethical approvals, viii. Vulnerability, ix. Tool selection); II. Data Collection and Analysis (x. concurrent data collection and analysis, xi. Targeted populations and recruitment procedures); III. Restitution and Dissemination (xii. Restitution and dissemination of findings, xiii. Impact). Our rapid review and evaluation found a wide range of feasible and highly effective tools, analytical approaches and timely operational insights and recommendations during epidemic emergencies.

Risk perception of Ebola virus disease and COVID-19 among transport drivers living in Ugandan border districts.

Background: Cross-border movements between districts bordering Uganda and the Democratic Republic of Congo (DRC) are common due to the interdependence between populations on either side, though this increases the risk of the international spread of infectious diseases. Due to the nature of their work, boda boda drivers (motorcycle taxis), taxis and truck drivers continue to cross the border during epidemics. However, perceived risk of contracting and spreading communicable diseases may be influenced by several factors such as the level of education, packaging and perception of health care messages, limited interaction with local socio-cultural dynamics or personal experiences. This study aims to explore differences in movement patterns and risk perceptions as factors for transmission among transport drivers in Ugandan border districts during the 2018-2020 Ebola Virus Disease (EVD) epidemic and the current COVID-19 pandemic. Methods: Between May and June 2021, in-depth interviews and focus group discussions were conducted with transport drivers in three Ugandan districts bordering DRC (Kasese, Kisoro and Hoima). Participants were asked about their knowledge and beliefs about EVD and COVID-19, perceived risk during epidemics, reasons for, and travel patterns during the EVD epidemic and COVID- 19 pandemic. A thematic content analysis was applied. Results: Participants' awareness of EVD was higher than that of COVID-19 however, the risk of transmission of Ebola virus was perceived as a remote threat. Measures restricting mobility during the COVID-19 pandemic had a greater impact on transport drivers compared to those implemented during the EVD epidemic, and were perceived as prohibitive rather than protective, largely due to fear of reprisals by security officers. Despite this, drivers were unlikely to be able to comply with the restrictions as they relied on their work as a source of income. Conclusion: The vulnerabilities of transport drivers should be considered in the context of epidemics such EVD and COVID-19 in Uganda. Policy makers should address these particularities and assess the impact of public health measures on transport drivers' mobility and involve them in designing of mobility-relatedpolicies.

Conducting Social Science Research During Epidemics and Pandemics: Lessons Learnt.

The COVID-19 pandemic has had a significant impact on how field-based research is being conducted globally. Given the challenges of undertaking fieldwork during epidemics and the need for mixed methods research to address the social, political, and economic issues related to epidemics, there is a small but growing body of evidence in this area. To contribute to the logistical and ethical considerations for conducting research during a pandemic, we draw on the challenges and lessons learnt from adapting methods for two research studies conducted in 2021 during the COVID-19 pandemic in low- and middle-income country (LMIC) settings: (1) in-person research in Uganda and (2) combined remote and in-person research in South and Southeast Asia. Our case studies focus on data collection and demonstrate the feasibility of conducting mixed methods research, even with many logistical and operational constraints. Social science research is often used to identify the context of specific issues, to provide a needs assessment, or inform longer-term planning; however, these case studies have shown the need to integrate social science research from the start of a health emergency and in a systematic way. Social science research during future health emergencies can also inform public health responses during the emergency. It is also crucial to collect social science data after health emergencies to inform future pandemic preparedness. Finally, researchers need to continue research on other public health issues that are ongoing even during a public health emergency.

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

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.

Factors associated with attendance to a participatory gender training programme - A secondary analysis of data from the MAISHA study.

Participatory gender training is often included in programmes aimed at preventing intimate partner violence (IPV) in low- and middle-income countries. Higher attendance is associated with greater benefit. Using data from two trials, conducted in Tanzania from 2014 to 2019 (MAISHA study), we retrospectively examined associations between individual and group-level factors and attendance at a gender training intervention, among women in established microfinance groups (CRT01, n = 528), and in newly-formed neighbourhood groups (CRT02, n = 629). High attendance was defined as participation in 7 or more of 10 sessions. More women were high attenders in CRT02 (81.74 %) than CRT01 (66.67 %). In both trials, older age was positively associated with attendance (CRT01: adjusted odds ratio [aOR]: 2.43, 95 %CI: 1.42-4.15, p = 0.001 and CRT02: aOR: 2.00, 95 %CI: 1.10-3.61, p = 0.023). In CRT01 only, past IPV victimization was positively associated with attendance (aOR: 1.71, 95 %CI: 1.07-2.73, p = 0.024), while secondary education and larger group size were negatively associated with attendance (aOR: 0.59, 95 %CI: 0.36-0.97, p = 0.038 and aOR: 0.38, 95 %CI: 0.19-0.75, p = 0.006 respectively). There was limited evidence of associations between factors examined and attendance in CRT02. Programme implementers should consider potential barriers to women's engagement and implement strategies to support participation, particularly for younger women, given their increased risk of IPV.

The Role of Structural Factors in Support-Seeking Among Women Experiencing Intimate Partner Violence (IPV) in Mwanza, Tanzania: Findings From a Qualitative Study.

In this qualitative study of women participating in an intimate partner violence (IPV) prevention trial, experiences of IPV and the context that shapes support-seeking were explored through in-depth interviews and focus groups discussions. Decisions to seek support were influenced by a range of factors including fear of further abuse, shame, acceptance of IPV as normal, belief that IPV is a private matter between the couple, economic dependence on male partners, and a poorly responsive legal and justice system. Gender empowerment programs need to intervene at the social, cultural, political, and economic levels that shape justification and meanings attached to IPV and women's decisions in seeking support.

Contesting the crisis narrative: epidemic accounts in Sierra Leone, Tanzania, and Democratic Republic of the Congo.

Scientists and global commentators watched African countries closely in the early months of the COVID-19 pandemic, predicting an impending disaster: the virus was projected to overwhelm already weak health systems. These expectations were informed by imaginaries of Africa as an inevitable site of epidemic disaster. This paper draws on accounts from Sierra Leone, Tanzania, and Democratic Republic of the Congo to contrast global catastrophe framings with everyday imaginations and experiences of crisis and crisis management. Utilising ethnographic research, the paper initially explores how COVID-19 was understood in relation to previous epidemics, from HIV (human immunodeficiency virus) to Ebola, as well as political conflict. It then considers how global crisis narratives both inform and are in tension with everyday collective and personal experiences. The paper brings these empirical reflections into a conversation with theoretical debates on the discursive construction of crisis and its effects, and argues that these tensions matter because crisis framings have consequences.

Randomized Trial of Vaccines for Zaire Ebola Virus Disease.

BACKGROUND: Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease. METHODS: We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4. RESULTS: A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14. CONCLUSIONS: No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.).

The role of cultural safety and ethical space within postcolonial healthcare for Maasai in Tanzania.

The history of the Maasai tribe in northern Tanzania is characterised by marginalisation, discrimination and political subjugation. Inequities, enacted through power relations, influence healthcare access, practices and outcomes among the Maasai. Cultural safety and ethical space provide lenses into social, political and historical influences on access to care, helping to understand the realities of historically marginalised populations such as the Maasai, and responses to health services. This study aims to examine Maasai experiences of accessing and uptake of health services within a postcolonial discourse in Tanzania. In an ethnographic study examining access and perceptions of healthcare services in Maasai communities, lead authors conducted participant observations and at health facilities to document experiences. Household interviews, a group oral history and interviews with NGOs working with Maasai communities, contributed to the data analysed. Inductive thematic analysis was used to understand healthcare experiences within a framework of cultural safety and ethical space. Despite trust in biomedicine, Maasai people have a strong desire for health services with particular characteristics. Quality of care, including facilities and diagnostics available and used, was important. A sense of fairness was a determinant in respecting services including 'first come first serve' system and transparency when unable to treat a condition. Trust in health services was also influenced by personal interactions with health workers, including provision of health information provided to patients and instances of being mistreated. These findings offer an understanding of ways in which spaces of healthcare can be more approachable and trusted by Maasai. Incorporating cultural safety and ethical spaces to understand healthcare access can help to reduce the power imbalance possibly resulting from a history of marginalisation. This can inform development of culturally appropriate programmes, used to educate healthcare professionals and advocate for improved healthcare services for marginalised groups.

Changing gear: Experiences of how existing qualitative research can adapt to an unfolding health emergency.

Long-term research projects are not always able to adapt to a new crisis and incorporate characteristics and approaches of rapid research to produce useful data quickly. Project AViD was a programme of research that ran between 2018 and 2022 to examine factors that shape vaccine confidence. The project initially focused on five country case studies looking at vaccines for Ebola, Measles, Rift Valley Fever and Zika. The COVID-19 pandemic emerged during this time and provided an opportunity to contribute to the pandemic's 'million-dollar question'-how to deploy COVID-19 vaccines. Drawing on our experience as researchers, and specifically from AViD, we propose seven factors that can influence when and how longer-term qualitative research projects can adapt and contribute to the response to an unfolding health emergency. These include: (1) the phase of research in which the emergency hits; (2) the relative significance of the emergency in the research setting; (3) the specific methods and research team capacities; (4) existing operational links; (5) supportive ecosystems; (6) flexibility in research contracting and funding; and (7) the research team attitude and approach. We close with two considerations for longer-term research projects that find themselves having to "change gear" amid a public health emergency-the need to re-assess risks and benefits and the need to protect equitable partnerships.

Human preparedness: Relational infrastructures and medical countermeasures in Sierra Leone.

This paper examines health worker experiences in two areas of post-epidemic preparedness in Sierra Leone - vaccine trials and laboratory strengthening - to reflect on the place of people in current models of epidemic response. Drawing on ethnographic research and interviews with health workers in the aftermath of Ebola, it explores the hopes and expectations that interventions foster for frontline workers in under-resourced health systems, and describes the unseen work involved in sustaining robust response infrastructures. Our analysis focuses on what it means for the people who sustain health systems in an emergency to be 'prepared' for an epidemic. Human preparedness entails more than the presence of a labour force; it involves building and maintaining 'relational infrastructures', often fragile social and moral relationships between health workers, publics, governments, and international organisations. The COVID-19 pandemic has underscored the value of rethinking human resources from an anthropological perspective, and investing in the safety and support of people at the forefront of response. In describing the labour, personal losses, and social risks undertaken by frontline workers for protocols and practicality to meet in an emergency context, we describe the social process of preparedness; that is, the contextual engineering and investment that make response systems work.

Family Planning in the Sierra Leone Ebola Outbreak: Women's Proximal and Distal Reasoning.

Sierra Leone was highly impacted by the 2014-2016 West Africa Ebola outbreak, with 3,955 recorded deaths. Already stressed maternal health services were deeply affected by the outbreak due to fears of viral transmission, reallocation of maternity staff, and broader policies to stop transmission including travel restrictions. This research sought to explore women's perspectives on delaying pregnancy during the Ebola outbreak using family planning methods. Qualitative data collection took place in Kambia District in 2018 and included 35 women participants, with women who were either family planning users or nonusers at the time of the outbreak. Women reported a variety of reasons for choosing to take or not to take family planning during the outbreak, which we categorized as proximal (directly related to the outbreak) or distal (not directly outbreak related). Proximal reasons to take family planning included to avoid interacting with health care spaces where Ebola could be transmitted, to avoid the economic burden of additional children in a time when economic activities were curtailed and to return to school when education resumed postoutbreak. Distal reasoning included gender roles affecting women's decision making to seek family planning, concerns related to the physiological side effects of family planning, and the economic burden of paying for family planning. Women's perspectives for choosing to take or not take family planning during the Sierra Leone Ebola crisis had not been explored prior to this paper. Using the lens of family planning to consider how women choose to access health care in an outbreak gives us a unique perspective into how all health care interactions are impacted by a generalized outbreak of Ebola, and how outbreak responses struggle to ensure such services remain a priority.

"Are You Sure It's Not the Corona Vaccine?" An Ebola Vaccine Trial During COVID-19 in DRC.

The COVID-19 pandemic began as an Ebola epidemic was unfolding in the Democratic Republic of the Congo. In this article, we examine how COVID-19 influenced experiences of an Ebola vaccine trial and attitudes towards medical research in Goma. First, critical debates about vaccine research became a forum in which to contest ineffective local governance and global inequality. Second, discussions about new COVID-19 therapeutics reignited critique of Western biomedical colonialism. Third, rumors were made powerful through everyday observations of the unexpected adaption of Ebola trial procedures in the pandemic. This illustrates the difficulties of maintaining participants' trust, when circumstances dictate protocol alterations mid-trial.

Attributing public ignorance in vaccination narratives.

The notion of an 'ignorant public' is attributed in outbreak scenarios through vaccination narratives that are institutionally reinforced by governments and the media across different contexts. The ignorant public narrative is a discursive shift that reduces public concerns about vaccines to a lack of knowledge, obscuring how these concerns are indicative of mistrust and anxiety or efforts to counter the dominance of acceptable and legitimate knowledge. This narrative risks a deflection of challenges in the structural determinants of vaccine uptake and depoliticise rumours and mistrust that arise during vaccination campaigns. Examples from Sierra Leone, Uganda, and India show how 'ignorant public' framings are used as explanation for vaccine hesitancy through assigned roles for institutions and publics, and the consequences this narrative has for vaccination encounters. These examples are based on ethnographic fieldwork and media analysis carried out before, during, and after outbreaks, of newly introduced vaccines for both human and animal health. Drawing on science communication and development studies, we show how this narrative then positions governmental concern about vaccine hesitancy as being a (largely) imagined issue of public ignorance. We argue that when institutions tasked with strengthening vaccine uptake see public ignorance as the key problem, this can obscure other problems, such as competing interests and experiences, and also minority group treatment. As a result, public governance is rationalised by assigning the ignorance label to certain public groups that stand in contrast to scientific and government expertise, and so accountability for low vaccine uptake is transferred onto the public.

Longitudinal inconsistencies in women's self-reports of lifetime experience of physical and sexual IPV: evidence from the MAISHA trial and follow-on study in North-western Tanzania.

BACKGROUND: Intimate partner violence (IPV) against women is pervasive throughout the world, with profound consequences for women's health. Research to understand the extent, causes and consequences of IPV relies on self-reported data on violence, and yet there is a paucity of research into the consistency with which women report lifetime IPV over time. METHODS: We use data from the control group of the cluster randomised trial and a follow-on longitudinal study in Tanzania to examine discrepancies in women's reported experience of lifetime physical IPV and sexual IPV over three time-points (T0, T29, T53 months). Among those reporting lifetime history of IPV at T0, we calculate the proportion who subsequently report no lifetime history at T29 and/or T53 ('discrepant' reporting). We use logistic regression to explore associations between discrepant reporting and respondent baseline characteristics, the nature of their IPV experiences at baseline, and situational factors at T53. RESULTS: Complete IPV data were available for 301 women. At T0, 154 (51%) women reported lifetime history of physical IPV, of whom 62% gave a discrepant 'never' report in a subsequent round. Among 93 (31%) with lifetime history of sexual IPV at T0, 73% provided a subsequent discrepant report. 73% of women reported lifetime physical IPV, and 55% lifetime sexual IPV in at least one survey round. For both IPV outcomes, women were less likely to provide discrepant reports if they had recent IPV at baseline, poor mental health (T53) and poor communication with partner (T53). For physical IPV only, reduced discrepant reporting was also associated with baseline household-level financial hardship and more severe or extensive experience of IPV. CONCLUSIONS: A large proportion of women provided discrepant reports over the course of the study. Prevalence estimates of lifetime IPV from one-off cross-sectional surveys are likely to be underestimates, biased towards more recent and severe cases. To improve the stability of IPV measures, researchers should explicitly clarify the meaning of reference periods such as 'ever', consider using shorter reference periods (e.g. past-year), and avoid filter questions that use positive reports of lifetime IPV as a gateway to asking about more recent experiences. TRIAL REGISTRATION: Maisha CRT01 registered at ClinicalTrials.gov #NCT02592252, registered retrospectively (13/08/2015).

Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo.

INTRODUCTION: Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness. METHODS AND ANALYSIS: This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were passively recorded until 1 month post dose 2. 1000 safety subset participants were telephoned at 1 month post dose 2 to collect SAEs. 500 pregnancy subset participants were contacted to collect SAEs at D7 and D21 post dose 1 and at D7, 1 month, 3 months and 6 months post dose 2, unless delivery was before these time points. The first 100 infants born to these women were given a clinical examination 3 months post delivery. Due to COVID-19 and temporary suspension of dose 2 vaccinations, at least 50 paediatric and 50 adult participants were enrolled into an immunogenicity subset to examine immune responses following a delayed second dose. Samples collected predose 2 and at 21 days post dose 2 will be tested using the Ebola viruses glycoprotein Filovirus Animal Non-Clinical Group ELISA. For qualitative research, in-depth interviews and focus group discussions were being conducted with participants or parents/care providers of paediatric participants. ETHICS AND DISSEMINATION: Approved by Comité National d'Ethique et de la Santé du Ministère de la santé de RDC, Comité d'Ethique de l'Ecole de Santé Publique de l'Université de Kinshasa, the LSHTM Ethics Committee and the MSF Ethics Review Board. Findings will be presented to stakeholders and conferences. Study data will be made available for open access. TRIAL REGISTRATION NUMBER: NCT04152486.

Women's economic status, male authority patterns and intimate partner violence: a qualitative study in rural North West Province, South Africa.

There are conflicting views on the impact of microfinance-only interventions on women's economic empowerment and intimate partner violence in low and middle-income countries. Evidence suggests however that when microfinance is combined with complementary programmes (microfinance plus) it may be effective for empowering women and addressing intimate partner violence. We conducted in-depth interviews with adult women in rural South Africa who had received microfinance loans for more than a year and had recently completed gender training. We explored women's perceptions on income generation; the effects on their relationships, including intimate partner violence; their notions of power; and perspectives on men's reactions to their empowerment. Findings reveal that the notion of 'power within the self' is supported by women's income generation, alongside a sense of financial independence and improved social support. Women reported increased happiness and reduced financial stress, although social norms and gender expectations about women subservience and male headship remain salient, particularly among older women. Furthermore, younger women appeared to tolerate abuse due to financial and caring responsibilities. These findings underpin the importance of complementary gender training programmes and of including men as participants for enhancing the effectiveness of economic strengthening interventions.

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial.

BACKGROUND: Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. METHODS: This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1-17 years were enrolled in three age cohorts (12-17 years, 4-11 years, and 1-3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov, NCT02509494. FINDINGS: From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1-3 years after placebo injection to 21% (30 of 144) of children aged 4-11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12-17 years and 4-11 years age cohorts after the first and second dose, and pyrexia in the 1-3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12-17 years (9929 ELISA units [EU]/mL [95% CI 8172-12 064]), in 119 (99%) of 120 aged 4-11 years (10 212 EU/mL [8419-12 388]), and in 118 (98%) of 121 aged 1-3 years (22 568 EU/mL [18 426-27 642]). INTERPRETATION: The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1-17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children. FUNDING: Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.