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Little information exists regarding Ebola vaccine rVSVΔGZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant 15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.

Background Sepsis is the leading cause of global mortality, and it is frequently attributed to lower respiratory tract infections and subsequent acute respiratory distress syndrome (ARDS). Patients from sub-Saharan Africa (sSA) are underrepresented in existing studies of sepsis, and little is known about ARDS in sSA. Severe respiratory distress (SRD) is a surrogate for ARDS defined by the WHO as O2 saturation 30 breaths/minute and a systolic blood pressure >90 mmHg plus suspected infection in the absence of cardiac failure. In the context of the current COVID-19 pandemic, a better understanding of SRD in sSA is urgently needed. In this study, we aimed to determine the prevalence, clinical characteristics, and in-hospital mortality of adults with SRD in sSA. Methods We analyzed pooled individual-level data from 16 studies of hospitalized patients conducted in 6 countries throughout sSA from 2009 to 2019. We used multiple imputation with chained equations with 10 iterations to impute missing data. We performed multivariable logistic regression to estimate associations between patient vital signs, laboratory studies, SRD, and in-hospital mortality. We characterized factors associated with in-hospital mortality in the subset of patients with SRD. Results The pooled data included 7385 patients with a median age of 37 years, of whom 3584 (49%) were women, 2282 (31%) were living with HIV, 3190 (43%) had a known acute infection, and 946 (13%) had SRD. The mortality for the total population and for patients with SRD was 15% and 22%, respectively. Older age, lower temperature, increased heart rate, increased respiratory rate, decreased oxygen saturation, Glasgow Coma Scale score

The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) was a randomized, controlled trial of rVSVΔG-ZEBOV-GP vaccine in healthcare and frontline workers during the 2014–2016 Ebola epidemic. Overall safety findings have been previously reported; there were no vaccine-related serious adverse events (SAEs). Here we describe the safety monitoring system established for STRIVE and the health conditions that resulted in reported SAEs, as well as factors affecting SAE incidence. Participants were randomized to immediate (≤7 days) or deferred (18–24 weeks later) vaccination and were monitored for safety for 6 months (immediate-vaccinated group) or until vaccination (deferred [unvaccinated] group). Once vaccinated, the latter group was termed crossover-vaccinated and monitored for 6 additional months. Of the 8577 STRIVE participants with safety follow-up data, 4172 were in the immediate-vaccinated group and 4398 were in the unvaccinated group, of whom 3787 received crossover vaccination. Overall, 143 SAEs were reported among 132 participants. Of the 143 SAEs, 130 (90.9%) resulted in hospitalization, and 24 (18.2%) participants with an SAE died. Infections were the most common SAEs; malaria was the most common single diagnosis and the most common cause of death. STRIVE built local capacity for vaccine safety monitoring in future clinical trials and research and in the national immunization program. This information about serious health conditions that resulted in hospitalization or death among a population of relatively young, healthy adults in Sierra Leone could help inform improved delivery of preventive and therapeutic health services. Clinical Trials Registration ClinicalTrials.gov [{"type":"clinical-trial","attrs":{"text":"NCT02378753","term_id":"NCT02378753"}}NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

The impact of the 2014–2016 Ebola epidemic in West Africa on human immunodeficiency virus (HIV) treatment in Sierra Leone is unknown, especially for groups with higher HIV prevalence such as the military. Using a retrospective study design, clinical outcomes were evaluated prior to and during the epidemic for 264 HIV-infected soldiers of the Republic of Sierra Leone Armed Forces (RSLAF) and their dependents receiving HIV treatment at the primary RSLAF HIV clinic. Medical records were abstracted for baseline clinical data and clinic attendance. Estimated risk of lost to follow-up (LTFU), default, and number of days without antiretroviral therapy (DWA) were calculated using repeated measures general estimating equations adjusted for age and gender. Due to missing data, 262 patients were included in the final analyses. There was higher risk of LTFU throughout the Ebola epidemic in Sierra Leone compared to the pre-Ebola baseline, with the largest increase in LTFU risk occurring at the peak of the epidemic (relative risk: 3.22, 95% CI: 2.22–4.67). There was an increased risk of default and DWA during the Ebola epidemic for soldiers but not for their dependents. The risk of LTFU, default, and DWA stabilized once the epidemic was largely resolved but remained elevated compared to the pre-Ebola baseline. Our findings demonstrate the negative and potentially lasting impact of the Ebola epidemic on HIV care in Sierra Leone and highlight the need to develop strategies to minimize disruptions in HIV care with future disease outbreaks.

The West Africa Ebola epidemic stimulated rapid implementation of Ebola vaccine trials in the 3 highly affected countries. In Sierra Leone, we studied the recombinant vesicular stomatitis virus Ebola vaccine (rVSV∆G-ZEBOV-GP) safety and efficacy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a randomized, unblinded Phase 2/3 trial with phased vaccine introduction, no placebo, and concurrent evaluation of vaccine safety and efficacy. Healthcare and frontline response workers in 5 districts were randomized to immediate or deferred (18–24 weeks later) vaccination and followed for 6 months postvaccination. We enrolled 8651 participants from April through August 2015; 7998 were vaccinated. No participants developed Ebola virus disease so an efficacy assessment was not possible. Overall, 132 (1.5%) participants experienced serious adverse events (SAEs); none were vaccine-related. In a detailed safety substudy (N = 436), vaccinated participants reported significantly more systemic adverse events (AEs) within 7 days than unvaccinated participants including fever higher than 38°C (20.5% vs 3.9%), headache (71.2% vs 22.1%), fatigue (50.7% vs 10.4%), and joint pain (31.7% vs 6.5%); most AEs were mild to moderate severity and resolved within 5 days. During days 5-28, vaccinated participants more commonly reported joint pain (17.0% vs 4.8%) and rash (7.8% vs 1.7%) (P

The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a clinical trial of the investigational recombinant vesicular stomatitis virus–based Ebola virus vaccine (rVSV∆ZEBOV-GP; Merck), provided an opportunity to assess health conditions in a cohort of healthy Sierra Leonean adults before vaccination. Of the 8793 healthcare and frontline Ebola response workers screened for study enrollment, 7 (0.1%) self-reported human immunodeficiency virus infection or another significant immunodeficiency disorder and 11 of 3190 (0.3%) women 18–49 years old had a positive urine pregnancy test. Of the 440 participants included in a safety substudy, 124 (28.2%) reported at least 1 medical condition at baseline, most commonly drug hypersensitivity (11.6%), arthralgia (3.9%), arthropathy (2.7%), or gastric (3.0%) or peptic (2.7%) ulcer disease. We calculated the incidence per 100 person-years (PY) and 95% confidence intervals (CIs) of new medical conditions among the 4297 participants followed for 18–24 weeks from enrollment to scheduled vaccination. The most commonly reported conditions were headache (32.4 PY [95% CI, 29.7–35.3 PY]), pain (unspecified) (17.3 PY [95% CI, 15.4–19.4 PY]), arthralgia (9.3 PY [95% CI, 7.9–10.8 PY]), and abdominal pain (9.1 PY [95% CI, 7.7–10.7 PY]). Nasopharyngitis (7.0 PY [95% CI, 5.8–8.4 PY]) and malaria (1.9 PY [95% CI, 1.3–2.7 PY]) were the most commonly reported infectious conditions. Several cases of hypertension, diabetes mellitus, and cancer were also reported. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

BackgroundWhile bacterial vaginosis has been associated with an increased risk of Trichomonas vaginalis (TV) acquisition, it is unknown whether other characteristics of the vaginal microbiota, including the presence of key bacterial species, influence a woman’s risk of TV acquisition.MethodsThe vaginal microbiota before 25 unique episodes of TV infection involving 18 women was compared to that of 50 controls who remained uninfected. TV was detected by transcription-mediated amplification. Vaginal microbiota were quantified using broad-range polymerase chain reaction analysis and taxon-specific quantitative PCR of the 16S ribosomal RNA gene.ResultsTV acquisition was significantly associated with the presence of Prevotella amnii (risk ratio [RR], 2.21; 95% confidence interval [CI], 1.12–4.38; P = .02) and Sneathia sanguinegens (RR, 2.58; 95% CI, 1.00–6.62; P = .049). When adjusted for menstrual phase, the association between P. amnii and TV acquisition remained similar (adjusted RR, 2.11; 95% CI, 1.03–4.33; P = .04), but the association between S. sanguinegens and TV acquisition was attenuated (adjusted RR, 2.31; 95% CI, .86–6.23; P = .10).ConclusionsKey vaginal bacterial species may contribute to the susceptibility to TV acquisition. Understanding how these bacterial species increase a woman’s risk of TV acquisition could help to guide the development of novel strategies to reduce women’s risk of TV infection.

Devise-related infections after deep brain stimulator implantation are not uncommon. However, infections due to mycobacteria have not been reported in the medical literature. We describe the first reported case of DBS infection due to a novel rapidly growing mycobacteria, most closely resembling Mycobacterium goodii, by rpoB gene sequencing.

Introduction We tested the hypothesis that vaginal microbiota influence women’s susceptibility to T. vaginalis (TV) acquisition. Methods We conducted a nested case-control study of 25 episodes of TV infection using vaginal samples collected 30–60 days prior to infection in 18 HIV-negative women and 50 incidence-density matched controls. Broad-range 16S rRNA gene PCR was used to measure total vaginal bacterial load. Deep sequencing was applied to 18 first episodes of TV infection and 36 matched controls to measure bacterial diversity (Shannon index) and species richness (Chao-1 index). Bacterium-specific quantitative PCR was performed for Lactobacillus crispatus , Prevotella amnii , Sneathia sanguinegens , Dialister species Type 2, Bacterial Vaginosis Associated Bacterium 1 (BVAB-1), and Mageeibacillus indolicus for all TV infection cases and controls. The associations between Shannon and Chao-1 indices and TV acquisition were evaluated using logistic regression. Generalised estimating equations with logit link were used to evaluate associations between TV acquisition, detection of bacterial species, and total vaginal bacterial load. Results There was no association between total vaginal bacterial load, species diversity, or richness, and likelihood of TV acquisition. Detection of S. sanguinegens (odds ratio [OR] 4.00, 95% CI 1.19–13.50) and P. amnii (OR 3.45, 95% CI 1.29–9.24) were both associated with TV acquisition. M. indolicus was also associated with TV acquisition (OR 2.47, 95% CI 0.88–6.93), although not significantly. Compared to women with none of these species, women with all three bacterial species had substantially higher likelihood of TV acquisition (none-reference category; one-OR 1.57, 95% CI 0.21–11.86; two-OR 4.50, 95% CI 0.93–21.76; three-OR 5.50, 95% CI 1.15–26.40). There was no association with the other three bacterial species. Conclusion The presence of three bacterial species commonly associated with BV may increase susceptibility to TV infection. Elimination of these bacteria could be explored as an approach to decrease women’s risk of trichomoniasis.

BACKGROUND: Critical illness is a leading cause of morbidity and mortality in sub-Saharan Africa (SSA). Identifying patients with the highest risk of death could help with resource allocation and clinical decision making. Accordingly, we derived and validated a universal vital assessment (UVA) score for use in SSA.METHODS: We pooled data from hospital-based cohort studies conducted in six countries in SSA spanning the years 2009-2015. We derived and internally validated a UVA score using decision trees and linear regression and compared its performance with the modified early warning score (MEWS) and the quick sepsis-related organ failure assessment (qSOFA) score.RESULTS: Of 5573 patients included in the analysis, 2829 (50.8%) were female, the median (IQR) age was 36 (27-49) years, 2122 (38.1%) were HIV-infected and 996 (17.3%) died in-hospital. The UVA score included points for temperature, heart and respiratory rates, systolic blood pressure, oxygen saturation, Glasgow Coma Scale score and HIV serostatus, and had an area under the receiver operating characteristic curve (AUC) of 0.77 (95% CI 0.75 to 0.79), which outperformed MEWS (AUC 0.70 (95% CI 0.67 to 0.71)) and qSOFA (AUC 0.69 (95% CI 0.67 to 0.72)).CONCLUSION: We identified predictors of in-hospital mortality irrespective of the underlying condition(s) in a large population of hospitalised patients in SSA and derived and internally validated a UVA score to assist clinicians in risk-stratifying patients for in-hospital mortality. The UVA score could help improve patient triage in resource-limited environments and serve as a standard for mortality risk in future studies.

There is a paucity of data on the etiologies and outcomes of febrile illness in rural Sierra Leone, especially in the Lassa-endemic district of Kenema. We conducted a retrospective study of patients with subjective or documented fever (T ≥ 38.0°C) who were admitted to a rural tertiary care hospital in Kenema between November 1, 2011 and October 31, 2012. Of 854 patients admitted during the study period, 429 (50.2%) patients had fever on admission. The most common diagnoses were malaria (27.3%), pneumonia (5.1%), and Lassa fever (4.9%). However, 53.4% of febrile patients had no diagnosis at discharge. The in-hospital mortality rate was 18.9% and associated with documented temperature ≥ 38.0°C (adjusted odds ratio [AOR] = 2.89, P = 0.001) and lack of diagnosis at discharge (AOR = 2.04, P = 0.03). Failure to diagnose the majority of febrile adults and its association with increased mortality highlight the need for improved diagnostic capacity to improve patient outcomes.

Since early in the AIDS epidemic, CD4 counts were recognized as the single best indicator of immunologic status in patients with HIV disease and are still used to define a patient’s risk of AIDS-related and other serious diseases. Thus, treatments that help boost CD4 counts beyond levels achieved by antiretroviral therapy (ART) alone may lead to improved health outcomes in patients with HIV disease. This could be of particular benefit in patients who fail to achieve significant increases in CD4 counts on ART despite achieving appropriate virologic control with low or undetectable HIV viral loads. Interleukin (IL)-2 is a potent inducer of CD4 cells, and subcutaneous recombinant IL-2 combined with ART results in significant sustained increases in CD4 counts in HIVinfected patients compared with ART alone. However, it is unclear if these increases in CD4 counts would translate into observed clinical benefit in HIV-infected individuals. In addition, there are many toxicities, some potentially fatal, associated with IL-2 use, which may outweigh any clinical benefit of this treatment. The Subcutaneous Recombinant, Human Interleukin-2 in HIV-Infected Patients With Low CD4 Cell Counts Under Active Antiretroviral Therapy (SILCAAT) and the Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) were international multicenter studies designed to address whether there was any clinical benefit from the use of IL-2 with ART beyond the known increases in CD4 counts.

We examined the association between metabolic syndrome (MS) and its individual defining criteria on all-cause mortality in human immunodeficiency virus (HIV)-infected persons. We used data from 567 HIV-infected participants of the Nutrition for Healthy Living study with study visits between 9/1/2000 and 1/31/2004 and determined mortality through 12/31/2006. MS was defined using modified National Cholesterol Education Program guidelines. Cox proportional hazards for all-cause mortality were estimated for baseline MS status and for its individual defining criteria. There were 83 deaths with median follow-up of 63 months. Baseline characteristics associated with increased risk of mortality were: older age in years (univariate hazard ratio [HR] 1.04, p

IL-22 has important functions at mucosal surfaces, including the induction of antimicrobial peptides and maintenance of epithelium. However, IL-22 has not been investigated in the genital tract during TV infection.Women who visited an STD clinic and women from a cohort with frequent Trichomoniasis were studied. IL-22, IL-17, and antimicrobial peptides were measured in cervicovaginal lavage by ELISA.In women visiting the STD clinic, those without STDs (n = 10) had a median IL-22 of 0 pg/mL, while women with infections (n = 30) had 27 pg/mL (P = 0.04). In the cohort, women with Trichomoniasis (n = 19) had significantly higher IL-22 than women with no infections (n = 21, 74 versus 0 pg/mL, P = 0.0001). IL-17 was also significantly increased in Trichomoniasis, and there was a correlation between IL-22 and IL-17 (P = 0.001).IL-22 is increased in STDs generally and in Trichomoniasis specifically suggesting an antimicrobial response of the mucosa and an epithelial repair process induced by the STDs.

We describe a 55-year-old HIV-1-infected male who developed severe dyslipidaemia (total cholesterol 600 mg/dl, triglycerides >5,000 mg/dl, high density lipoprotein