The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak

Abstract

ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Perspectives towards antiviral drug discovery against Ebola virus

“…The first outbreak resulted in 54 EVD cases (38 confirmed and 16 probable) and 33 deaths (overall case‐fatality ratio of 61%) as of 24 July, 2018 (declared the end of this outbreak), while the latter is ongoing, which includes 238 cases (203 confirmed and 35 probable) and 155 deaths resulting in a case‐fatality rate of 65.1% (as of 21 October, 2018) . Preclinical efforts toward specific EBOV countermeasures have been enduring for years with first treatment and vaccine clinical trials conducted during the 2013 to 2016 EBOV outbreak in West‐Africa . During the DRC outbreaks, the countermeasures were evaluated in West‐Africa EVD outbreak and demonstrated their clinical efficacy.…”

“…EBOV vaccine development has already been covered in previously published reviews . In brief, the recent update includes the development of replication‐competent rVSV‐ZEBOV (rVSV) used in May‐June 2018 Equateur DRC outbreak in a ring vaccination trial (Phase III; NCT03161366), which proved to be well tolerated with improved efficacy and safety . Currently, rVSV is being investigated along with other investigational therapeutics in the ongoing Kivu DRC outbreak (Phase II; NCT03719586).…”

“…During the outbreak, two prominent vaccines, rVSVΔG‐ZEBOV‐GP (rVSV) and cAd3‐EBO, were tested in clinical trials and proved to be efficacious . rVSV is currently in Phase II (NCT02876328 and NCT02788227) and is being tested in the United States and Africa.…”

“…This is the ninth outbreak in DRC in the last four decades (since 1976), with the last outbreak dated in May 2017 (8 cases with 4 deaths). Due to improved efficacy and safety of rVSV (evaluated in more than 10 000 individuals), the test treatment was administered during the May‐June 2018 DRC outbreak, currently being investigated in a ring vaccination trial (Phase III; NCT03161366). After the declaration of the end of Equateur DRC outbreak, another EVD outbreak was reported in Kivu and Ituri provinces of DRC on 1st August 2018.…”

Prevention of Ebola virus disease through vaccination: where we are in 2018

“…Additional safety and immunogenicity data on rVSVZEBOV have been generated in the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) study, which enrolled more than 8000 health-care and front-line workers in Sierra Leone, 6 and in a trial in Guinea (the Front Line Worker trial [PACTR201503001057193] sponsored by WHO and Médecins Sans Frontières). There have also been eight phase 1 trials 7–10 and a phase 3 safety and manufacturing-consistency trial 11 of the rVSV-ZEBOV vaccine conducted in North America, Europe, and Africa.…”