Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola

Jarrett, Olamide D; Seward, Jane F.; Fombah, Augustin E; Lindblad, Robert; Jalloh, Mohamed I; El-Khorazaty, Jill; Dawson, Peter; Burton, Deron C.; Zucker, Jane R.; Carr, Wendy; Bah, Mohamed M; Deen, Gibrilla F.; George, Peter; James, Faustine; Lisk, Durodami Radcliffe; Pratt, Dudley; Russell, James; Sandy, Jibao D; Turay, P; Hamel, Mary J.; Schrag, Stephanie J.; Walker, Robert; Samai, Mohamed; Goldstein, Susan T.

doi:10.1093/infdis/jiy042

Cited by 5 publications

(2 citation statements)

References 11 publications

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“…This administration is performed based on a caretaker's self-reports of their child's fever. Other routine uses of self-reported fever include the monitoring of severe adverse events during en masse treatment or vaccination campaigns [ 34 ]. Overall, self-reports of fever facilitate early detection and case management in areas with limited technological resources or clinical expertise.…”

Section: Methodsmentioning

confidence: 99%

Precision global health and comorbidity: a population-based study of 16 357 people in rural Uganda

Chami

Kabatereine

Tukahebwa

et al. 2018

J. R. Soc. Interface.

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In low-income countries, complex comorbidities and weak health systems confound disease diagnosis and treatment. Yet, data-driven approaches have not been applied to develop better diagnostic strategies or to tailor treatment delivery for individuals within rural poor communities. We observed symptoms/diseases reported within three months by 16 357 individuals aged 1+ years in 17 villages of Mayuge District, Uganda. Symptoms were mapped to the Human Phenotype Ontology. Comorbidity networks were constructed. An edge between two symptoms/diseases was generated if the relative risk greater than 1, ϕ correlation greater than 0, and local false discovery rate less than 0.05. We studied how network structure and flagship symptom profiles varied against biosocial factors. 88.05% of individuals (14 402/16 357) reported at least one symptom/disease. Young children and individuals in worse-off households—low socioeconomic status, poor water, sanitation, and hygiene, and poor medical care—had dense network structures with the highest comorbidity burden and/or were conducive to the onset of new comorbidities from existing flagship symptoms, such as fever. Flagship symptom profiles for fever revealed self-misdiagnoses of fever as malaria and sexually transmitted infections as a potentially missed cause of fever in individuals of reproductive age. Network analysis may inform the development of new diagnostic and treatment strategies for flagship symptoms used to characterize syndromes/diseases of global concern.

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Section: Methodsmentioning

confidence: 99%

Precision global health and comorbidity: a population-based study of 16 357 people in rural Uganda

Chami

Kabatereine

Tukahebwa

et al. 2018

J. R. Soc. Interface.

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“…Safety reporting from the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a randomized controlled trial of the rVSVΔG-ZEBOV-GP vaccine reported that vaccinated participants compared to unvaccinated participants had higher rates of post-vaccination malaria (incidence per 100 personyears [95% CI]: 0.59 [0.31-1.04] vs 0.12 [0.01-0.42]). 11 It is not clear what causal mechanism might explain this, and data on malaria severity were not reported. Our patient's case was reported to the vaccine manufacturer.…”

Section: Malaria As a Primary Differential Diagnosismentioning

confidence: 99%

Preparedness Tested: Severe Cerebral Malaria Presenting as a High-Risk Person Under Investigation for Ebola Virus Disease at a US Hospital

Anesi

Meyer

Reilly

et al. 2020

Disaster med. public health prep.

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In 2019, a 42-year-old African man who works as an Ebola virus disease (EVD) researcher traveled from the Democratic Republic of Congo (DRC), near an ongoing EVD epidemic, to Philadelphia and presented to the Hospital of the University of Pennsylvania Emergency Department with altered mental status, vomiting, diarrhea, and fever. He was classified as a “wet” person under investigation for EVD, and his arrival activated our hospital emergency management command center and bioresponse teams. He was found to be in septic shock with multisystem organ dysfunction, including circulatory dysfunction, encephalopathy, metabolic lactic acidosis, acute kidney injury, acute liver injury, and diffuse intravascular coagulation. Critical care was delivered within high-risk pathogen isolation in the ED and in our Special Treatment Unit until a diagnosis of severe cerebral malaria was confirmed and EVD was definitively excluded. This report discusses our experience activating a longitudinal preparedness program designed for rare, resource-intensive events at hospitals physically remote from any active epidemic but serving a high-volume international air travel port-of-entry.

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Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

Fombah

Goldstein

Jarrett

et al. 2018

The Journal of Infectious Diseases

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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].

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Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola

Cited by 5 publications

References 11 publications

Precision global health and comorbidity: a population-based study of 16 357 people in rural Uganda

Precision global health and comorbidity: a population-based study of 16 357 people in rural Uganda

Preparedness Tested: Severe Cerebral Malaria Presenting as a High-Risk Person Under Investigation for Ebola Virus Disease at a US Hospital

Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

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