Evidence map›Paper›PMID 29788343›Full record

ArticleThe Journal of infectious diseases2018

Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

Rosalind J Carter, Ayesha Idriss, Marc-Alain Widdowson, Mohamed Samai, Stephanie J Schrag, Jennifer K Legardy-Williams, Concepcion F Estivariz, Amy Callis, Wendy Carr, Winston Webber and 17 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02378753 ([rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02378753 phase2 / phase3completednot on this map

[rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2015 to 2016Enrolled8,651ConditionsHemorrhagic Fever, EbolaArmsrVSVΔG-ZEBOV
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 5 institutions in 2 countries.

Rosalind J CarterCenters for Disease Control and Prevention, Atlanta, Georgia.
Ayesha IdrissCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Marc-Alain WiddowsonCenters for Disease Control and Prevention, Atlanta, Georgia.
Mohamed SamaiCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Stephanie J SchragCenters for Disease Control and Prevention, Atlanta, Georgia.
Jennifer K Legardy-WilliamsCenters for Disease Control and Prevention, Atlanta, Georgia.
Concepcion F EstivarizCenters for Disease Control and Prevention, Atlanta, Georgia.
Amy CallisCenters for Disease Control and Prevention, Atlanta, Georgia.
Wendy CarrCenters for Disease Control and Prevention, Atlanta, Georgia.
Winston WebberCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Marc E FischerCenters for Disease Control and Prevention, Atlanta, Georgia.
Stephen HadlerCenters for Disease Control and Prevention, Atlanta, Georgia.
Foday SahrCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Melvina ThompsonCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Stacie M GrebyCenters for Disease Control and Prevention, Atlanta, Georgia.
Joseph Edem-HotahCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Roselyn M'baindu MomohCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Wendi McDonaldCenters for Disease Control and Prevention, Atlanta, Georgia.
Julianne M GeeCenters for Disease Control and Prevention, Atlanta, Georgia.
Ahamed Flagbata KallonCollege of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Dayo Spencer-WaltersE-Health Africa, Freetown, Sierra Leone.
Joseph S BreseeCenters for Disease Control and Prevention, Atlanta, Georgia.
Amanda CohnCenters for Disease Control and Prevention, Atlanta, Georgia.
Sara HerseyCenters for Disease Control and Prevention, Atlanta, Georgia.
Laura GibsonConceptual Mindworks, Inc., Washington DC.
Anne SchuchatCenters for Disease Control and Prevention, Atlanta, Georgia.
Jane F SewardCenters for Disease Control and Prevention, Atlanta, Georgia.
Centers for Disease Control and Prevention · USUniversity of Sierra Leone · SLConceptual Mindworks (United States) · USMinistry of Health and Sanitation · SLSierra Leone Urban Research Centre · SL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ≤-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Indexed as

Disease OutbreaksClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDrug-Related Side Effects and Adverse ReactionsEbola VaccinesFemaleHemorrhagic Fever, EbolaHumansMaleRandomized Controlled Trials as TopicSierra LeoneVaccines, SyntheticEbola VaccinesVaccines, Synthetic

Identifiers

PMID29788343
PMCPMC5961126
OpenAlexW2804203467

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.