Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report

Lancet Infectious Diseases
Dec 2017 Volume 17 Number 12 p1219-1318  e383-e433
http://www.thelancet.com/journals/laninf/issue/current

Articles

Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report
Pierre-Stéphane Gsell, Anton Camacho, Adam J Kucharski, Conall H Watson, Aminata Bagayoko, Séverine Danmadji Nadlaou, Natalie E Dean, Abdourahamane Diallo, Abdourahmane Diallo, Djidonou A Honora, Moussa Doumbia, Godwin Enwere, Elizabeth S Higgs, Thomas Mauget, Diakite Mory, Ximena Riveros, Fofana Thierno Oumar, Mosoka Fallah, Alhassane Toure, Andrea S Vicari, Ira M Longini, W J Edmunds, Ana Maria Henao-Restrepo, Marie Paule Kieny, Sakoba Kéïta
Open Access
Summary
Background
In March, 2016, a flare-up of Ebola virus disease was reported in Guinea, and in response ring vaccination with the unlicensed rVSV-ZEBOV vaccine was introduced under expanded access, the first time that an Ebola vaccine has been used in an outbreak setting outside a clinical trial. Here we describe the safety of rVSV-ZEBOV candidate vaccine and operational feasibility of ring vaccination as a reactive strategy in a resource-limited rural setting.
Methods
Approval for expanded access and compassionate use was rapidly sought and obtained from relevant authorities. Vaccination teams and frozen vaccine were flown to the outbreak settings. Rings of contacts and contacts of contacts were defined and eligible individuals, who had given informed consent, were vaccinated and followed up for 21 days under good clinical practice conditions.
Findings
Between March 17 and April 21, 2016, 1510 individuals were vaccinated in four rings in Guinea, including 303 individuals aged between 6 years and 17 years and 307 front-line workers. It took 10 days to vaccinate the first participant following the confirmation of the first case of Ebola virus disease. No secondary cases of Ebola virus disease occurred among the vaccinees. Adverse events following vaccination were reported in 47 (17%) 6–17 year olds (all mild) and 412 (36%) adults (individuals older than 18 years; 98% were mild). Children reported fewer arthralgia events than adults (one [<1%] of 303 children vs 81 [7%] of 1207 adults). No severe vaccine-related adverse events were reported.
Interpretation
The results show that a ring vaccination strategy can be rapidly and safely implemented at scale in response to Ebola virus disease outbreaks in rural settings.
Funding
WHO, Gavi, and the World Food Programme.