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Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSV\u0394G-ZEBOV-GP, 2-dose rVSV\u0394G-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 819 children and 783 adults were randomized to receive rVSV\u0394G-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSV\u0394G-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSV\u0394G-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A single dose of rVSV\u0394G-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSV\u0394G-ZEBOV-GP for the prevention of EVD in at-risk children.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciad693","type":"journal-article","created":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T16:21:01Z","timestamp":1700065261000},"page":"870-879","source":"Crossref","is-referenced-by-count":17,"title":["Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSV\u0394G-ZEBOV-GP Ebola Vaccine (ERVEBO\u00ae): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults"],"prefix":"10.1093","volume":"78","author":[{"given":"Andrew W","family":"Lee","sequence":"first","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Liu","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, 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