{"doi":"10.1093/cid/ciad693","title":"Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults","abstract":"BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-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. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-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. CONCLUSIONS: A single dose of rVSVΔG-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 rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. 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).","journal":"Clinical Infectious Diseases","year":2023,"id":340384,"datarank":0.6706250829360402,"base_score":2.833213344056216,"endowment":2.833213344056216,"self_citation_contribution":0.42498200160843247,"citation_network_contribution":0.24564308132760768,"self_endowment_contribution":0.42498200160843247,"citer_contribution":0.24564308132760768,"corpus_percentile":null,"corpus_rank":null,"citation_count":16,"citer_count":13,"citers_with_citation_signal":8,"citers_with_endowment":8,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9593,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02876328"],"PACTR":["201712002760250"],"EudraCT":["2017-001798-18"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":890330,"name":"Ken Liu","orcid":"0000-0002-0453-3168","position":1,"is_corresponding":false},{"id":588258,"name":"Édouard Lhomme","orcid":"0000-0003-0214-1694","position":2,"is_corresponding":false},{"id":726513,"name":"Julie Blie","orcid":null,"position":3,"is_corresponding":false},{"id":266147,"name":"John McCullough","orcid":"0000-0001-6836-4394","position":4,"is_corresponding":false},{"id":1075459,"name":"Matthew Onorato","orcid":null,"position":5,"is_corresponding":false},{"id":726534,"name":"Laurie Connor","orcid":null,"position":6,"is_corresponding":false},{"id":727771,"name":"Jakub K. Simon","orcid":null,"position":7,"is_corresponding":false},{"id":1074874,"name":"Sheri Dubey","orcid":"0000-0002-0712-9865","position":8,"is_corresponding":false},{"id":1075460,"name":"Susan M. VanRheenen","orcid":null,"position":9,"is_corresponding":false},{"id":1074875,"name":"Jonathan Deutsch","orcid":"0000-0003-0504-3598","position":10,"is_corresponding":false},{"id":1075461,"name":"Abigail Owens","orcid":null,"position":11,"is_corresponding":false},{"id":1075462,"name":"Amy Morgan","orcid":null,"position":12,"is_corresponding":false},{"id":1075463,"name":"Carolee Welebob","orcid":null,"position":13,"is_corresponding":false},{"id":498247,"name":"Donna Hyatt","orcid":null,"position":14,"is_corresponding":false},{"id":1075464,"name":"Sunita A. Nair","orcid":null,"position":15,"is_corresponding":false},{"id":1075465,"name":"Benjamin Hamzé","orcid":null,"position":16,"is_corresponding":false},{"id":1075466,"name":"Oumar Guindo","orcid":null,"position":17,"is_corresponding":false},{"id":299788,"name":"Samba O. Sow","orcid":"0000-0002-6335-5066","position":18,"is_corresponding":false},{"id":588259,"name":"Abdoul Habib Béavogui","orcid":"0000-0003-4950-6224","position":19,"is_corresponding":false},{"id":588603,"name":"Bailah Leigh","orcid":null,"position":20,"is_corresponding":false},{"id":479793,"name":"Mohamed Samai","orcid":"0000-0002-1427-9482","position":21,"is_corresponding":false},{"id":726493,"name":"Pauline Akoo","orcid":null,"position":22,"is_corresponding":false},{"id":639624,"name":"Alimamy Serry-Bangura","orcid":null,"position":23,"is_corresponding":false},{"id":940484,"name":"Suzanne Fleck","orcid":null,"position":24,"is_corresponding":false},{"id":1062255,"name":"Fatou Secka","orcid":null,"position":25,"is_corresponding":false},{"id":638730,"name":"Brett Lowe","orcid":"0000-0002-4422-8627","position":26,"is_corresponding":false},{"id":588263,"name":"Deborah Watson‐Jones","orcid":"0000-0001-6247-1746","position":27,"is_corresponding":false},{"id":588608,"name":"Céline Roy","orcid":null,"position":28,"is_corresponding":false},{"id":226712,"name":"Lisa E. Hensley","orcid":"0000-0003-1188-4342","position":29,"is_corresponding":false},{"id":588602,"name":"Mark Kieh","orcid":null,"position":30,"is_corresponding":false},{"id":497031,"name":"Beth-Ann Coller","orcid":"0000-0001-6006-1073","position":31,"is_corresponding":false},{"id":726490,"name":"the PREVAC study team","orcid":null,"position":32,"is_corresponding":false},{"id":682878,"name":"Jamila Aboulhab","orcid":null,"position":33,"is_corresponding":false},{"id":1075467,"name":"Michelle Aguirre-MacKenzie","orcid":null,"position":34,"is_corresponding":false},{"id":726494,"name":"Esther Akpa","orcid":null,"position":36,"is_corresponding":false},{"id":725786,"name":"Robert Akpata","orcid":"0000-0002-9628-8904","position":37,"is_corresponding":false},{"id":726495,"name":"Sara Albert","orcid":null,"position":38,"is_corresponding":false},{"id":725787,"name":"Boni Maxime Ale","orcid":"0000-0002-8449-3310","position":39,"is_corresponding":false},{"id":1075468,"name":"Serry Alimamy-Bangura","orcid":null,"position":40,"is_corresponding":false},{"id":1075469,"name":"Pierre Andong","orcid":null,"position":41,"is_corresponding":false},{"id":726496,"name":"Benetta C. Andrews","orcid":null,"position":42,"is_corresponding":false},{"id":726497,"name":"Stephane Anoma","orcid":null,"position":43,"is_corresponding":false},{"id":1067258,"name":"Negin Atri","orcid":null,"position":44,"is_corresponding":false},{"id":726499,"name":"Augustin Augier","orcid":null,"position":45,"is_corresponding":false},{"id":726500,"name":"Ken Awuondo","orcid":null,"position":46,"is_corresponding":false},{"id":588601,"name":"Moses Badio","orcid":null,"position":47,"is_corresponding":false},{"id":726501,"name":"Aminata Bagayoko","orcid":null,"position":48,"is_corresponding":false},{"id":726503,"name":"Abby Balde","orcid":null,"position":49,"is_corresponding":false},{"id":1075470,"name":"Joséphine Balssa","orcid":null,"position":50,"is_corresponding":false},{"id":639671,"name":"Lamin Molecule Bangura","orcid":null,"position":51,"is_corresponding":false},{"id":726504,"name":"Kesha Barrington","orcid":null,"position":52,"is_corresponding":false},{"id":726505,"name":"Eric Barte de Saint Fare","orcid":null,"position":53,"is_corresponding":false},{"id":726506,"name":"Beth Baseler","orcid":null,"position":54,"is_corresponding":false},{"id":726507,"name":"Ali Bauder","orcid":null,"position":55,"is_corresponding":false},{"id":726508,"name":"Claire Bauduin","orcid":null,"position":56,"is_corresponding":false},{"id":726509,"name":"Luke Bawo","orcid":null,"position":57,"is_corresponding":false},{"id":419088,"name":"Michael Belson","orcid":null,"position":59,"is_corresponding":false},{"id":726510,"name":"Marion Bererd","orcid":null,"position":60,"is_corresponding":false},{"id":726511,"name":"Teedoh Beyslow","orcid":null,"position":61,"is_corresponding":false},{"id":1075471,"name":"Jeanne Billioux","orcid":null,"position":62,"is_corresponding":false},{"id":1075472,"name":"Shere Billouin-Frazier","orcid":null,"position":63,"is_corresponding":false},{"id":726512,"name":"Blandine Binachon","orcid":null,"position":64,"is_corresponding":false},{"id":306135,"name":"Viki Bockstal","orcid":null,"position":66,"is_corresponding":false},{"id":726515,"name":"Patricia Boison","orcid":null,"position":67,"is_corresponding":false},{"id":1074876,"name":"Fatorma K. Bolay","orcid":"0000-0001-7730-3753","position":68,"is_corresponding":false},{"id":726517,"name":"Aliou Boly","orcid":null,"position":69,"is_corresponding":false},{"id":1075473,"name":"Anne-Gaëlle Borg","orcid":null,"position":70,"is_corresponding":false},{"id":1075474,"name":"Samuel Bosompem","orcid":null,"position":71,"is_corresponding":false},{"id":1075475,"name":"Courtney Bozman","orcid":null,"position":72,"is_corresponding":false},{"id":618565,"name":"Tyler Brady","orcid":"0009-0003-7434-7111","position":73,"is_corresponding":false},{"id":592568,"name":"Sarah Browne","orcid":null,"position":74,"is_corresponding":false},{"id":726520,"name":"Barbara Cagniard","orcid":null,"position":75,"is_corresponding":false},{"id":335384,"name":"Kelly Cahill","orcid":null,"position":76,"is_corresponding":false},{"id":440220,"name":"Yíngyún Caì","orcid":"0000-0002-1101-0920","position":77,"is_corresponding":false},{"id":726521,"name":"Aissata Abdoulaye Camara","orcid":null,"position":78,"is_corresponding":false},{"id":1075476,"name":"Aboubacar Keira Camara","orcid":null,"position":79,"is_corresponding":false},{"id":1075477,"name":"Alseny Camara","orcid":null,"position":80,"is_corresponding":false},{"id":1075478,"name":"Antoine Campagne","orcid":null,"position":81,"is_corresponding":false},{"id":726524,"name":"Cécilia Campion","orcid":null,"position":82,"is_corresponding":false},{"id":726525,"name":"Jennifer Cash","orcid":null,"position":83,"is_corresponding":false},{"id":726526,"name":"Siew Pin Chai","orcid":null,"position":84,"is_corresponding":false},{"id":726527,"name":"Francois Chambelin","orcid":null,"position":85,"is_corresponding":false},{"id":1075479,"name":"Michael Chea","orcid":null,"position":86,"is_corresponding":false},{"id":12041,"name":"Geneviève Chêne","orcid":"0000-0002-8368-6460","position":87,"is_corresponding":false},{"id":1075480,"name":"Michelle Chouinard","orcid":null,"position":88,"is_corresponding":false},{"id":1075481,"name":"Florence Chung","orcid":null,"position":89,"is_corresponding":false},{"id":1067259,"name":"Lucy Chung","orcid":null,"position":90,"is_corresponding":false},{"id":726529,"name":"Séverine Ciancia","orcid":null,"position":91,"is_corresponding":false},{"id":726530,"name":"Papa Ndiaga Cissé","orcid":null,"position":92,"is_corresponding":false},{"id":1075482,"name":"Elfrida Cline-Cole","orcid":null,"position":93,"is_corresponding":false},{"id":726532,"name":"Céline Colin","orcid":null,"position":94,"is_corresponding":false},{"id":726533,"name":"Djélikan Siaka Conde","orcid":null,"position":96,"is_corresponding":false},{"id":454022,"name":"Katherine Cone","orcid":null,"position":97,"is_corresponding":false},{"id":227096,"name":"Nicholas E. Connor","orcid":"0000-0002-5013-407X","position":99,"is_corresponding":false},{"id":1075458,"name":"Andrew W. Lee","orcid":null,"position":0,"is_corresponding":true}],"reference_count":28,"raw_metadata":null,"created_at":"2026-07-19T01:10:54.145367Z","pmid":"37967326","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}