Dataset Information

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

SUBMITTER: Samai M

PROVIDER: S-EPMC5961340 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

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.

Samai Mohamed M Seward Jane F JF Goldstein Susan T ST Mahon Barbara E BE Lisk Durodami Radcliffe DR Widdowson Marc-Alain MA Jalloh Mohamed I MI Schrag Stephanie J SJ Idriss Ayesha A Carter Rosalind J RJ Dawson Peter P Kargbo S A S SAS Leigh Bailah B Bawoh Mohamed M Legardy-Williams Jennifer J Deen Gibrilla G Carr Wendy W Callis Amy A Lindblad Robert R Russell James B W JBW Petrie Carey R CR Fombah Augustin E AE Kargbo Brima B McDonald Wendi W Jarrett Olamide D OD Walker Robert E RE Gargiullo Paul P Bash-Taqi Donald D Gibson Laura L Fofanah Abu Bakarr AB Schuchat Anne A

The Journal of infectious diseases 20180501 suppl_1

<h4>Clinical trials registration</h4>ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220]. ...[more]

PMID: 29788345

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Project description:BACKGROUND:As part of a Phase III trial with the Ebola vaccine rVSV?G-ZEBOV-GP in Guinea, we invited frontline workers (FLWs) to participate in a sub-study to provide additional information on the immunogenicity of the vaccine. METHODS:We conducted an open-label, non-randomized, single-arm immunogenicity evaluation of one dose of rVSV?G-ZEBOV-GP among healthy FLWs in Guinea. FLWs who refused vaccination were offered to participate as a control group. We followed participants for 84 days with a subset followed-up for 180 days. The primary endpoint was immune response, as measured by ELISA for ZEBOV-glycoprotein-specific antibodies (ELISA-GP) at 28 days. We also conducted neutralization, whole virion ELISA and enzyme-linked immunospot (ELISPOT) assay for cellular response. RESULTS:A total of 1172 participants received one dose of vaccine and were followed-up for 84 days, among them 114 participants were followed-up for 180 days. Additionally, 99 participants were included in the control group and followed up for 180 days. Overall, 86.4% (95% CI 84.1-88.4) of vaccinated participants seroresponded at 28 days post-vaccination (ELISA- GP) with 65% of these seroresponding at 14 days post-vaccination. Among those who seroresponded at 28 days, 90.7% (95% CI 82.0-95.4) were still seropositive at 180 days. The proportion of seropositivity in the unvaccinated group was 0.0% (95% CI 0.0-3.8) at 28 days and 5.4% (95% CI 2.1-13.1) at 180 days post-vaccination. We found weak correlation between ELISA-GP and neutralization at baseline but significant pairwise correlation at 28 days post-vaccination. Among samples analysed for cellular response, only 1 (2.2%) exhibited responses towards the Zaire Ebola glycoprotein (Ebola GP ? 10) at baseline, 10 (13.5%) at day 28 post-vaccination and 27 (48.2%) at Day 180. CONCLUSIONS:We found one dose of rVSV?G-ZEBOV-GP to be highly immunogenic at 28- and 180-days post vaccination among frontline workers in Guinea. We also found a cellular response that increased with time.

Dataset Information

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.

Publications

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.

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