{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:17:50Z","timestamp":1787563070518,"version":"build-2736575974"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,9,22]],"date-time":"2021-09-22T00:00:00Z","timestamp":1632268800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/501100012166","name":"National Key R&D Program of China","doi-asserted-by":"crossref","award":["2020YFC0849800"],"award-info":[{"award-number":["2020YFC0849800"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We assessed the safety and immunogenicity of a recombinant adenovirus type-5 (Ad5)\u2013vectored coronavirus disease 2019 (COVID-19) vaccine with homologous prime-boost regimens in healthy participants aged \u22656 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this randomized, double-blind, placebo-controlled trial, participants received vaccine or placebo 56 days apart. Enzyme-linked immunosorbent assay (ELISA) antibodies to the receptor binding domain (RBD) and pseudovirus neutralizing antibodies were detected. Adverse events were monitored for 28 days following each vaccination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 430 participants were enrolled in the study, with 30 participants aged 18\u201355 years (MID cohort), 250 aged \u226556 years (OLD cohort), and 150 aged 6\u201317 years (MIN cohort). Ad5-vectored COVID-19 vaccine induced significant RBD-specific ELISA antibodies that decreased with increasing age, with geometric mean titers (GMTs) of 1037.5 in the MIN cohort, 647.2 in the MID cohort, and 338.0 in the OLD cohort receiving 5 \u00d7 1010 viral particles on day 28 following boost vaccination. Pseudovirus neutralizing antibodies showed a similar pattern, with GMTs of 168.0 in the MIN cohort, 76.8 in the MID cohort, and 79.7 in the OLD cohort. A single dose in children and adolescents induced higher antibody responses than that elicited by 2 doses in adults, with GMTs of 1091.6 and 96.6 for ELISA antibody and neutralizing antibody, respectively. Homologous prime-boost vaccination was safe and tolerable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ad5-vectored COVID-19 vaccine with a single dose was safe and induced robust immune responses in children and adolescents aged 6\u201317 years. A prime-boost regimen needs further exploration for Ad5-vectored COVID-19 vaccine.<\/jats:p>\n                    <jats:p>Ad5-vectored COVID-19 vaccine with a single dose was safe and tolerated, and induced robust immune responses in children and adolescents aged 6-17 years. The boosting effect on immune responses of the homologous prime-boost regime given 56 days apart was limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT04566770.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab845","type":"journal-article","created":{"date-parts":[[2021,9,21]],"date-time":"2021-09-21T15:16:31Z","timestamp":1632237391000},"page":"e783-e791","source":"Crossref","is-referenced-by-count":78,"title":["Safety and Immunogenicity of a Recombinant Adenovirus Type-5\u2013Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged \u22656 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial"],"prefix":"10.1093","volume":"75","author":[{"given":"Fengcai","family":"Zhu","sequence":"first","affiliation":[{"name":"Vaccine Clinical Evaluation Department, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"},{"name":"National Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pengfei","family":"Jin","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Evaluation Department, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Zhu","sequence":"additional","affiliation":[{"name":"CanSino Biologics , Tianjin , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Evaluation Department, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huayue","family":"Ye","sequence":"additional","affiliation":[{"name":"Taizhou Center for Vaccine Clinical Research , Taizhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongxing","family":"Pan","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Evaluation Department, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lihua","family":"Hou","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biotechnology, Academy of Military Medical Sciences , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingxin","family":"Li","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Evaluation Department, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"},{"name":"National Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Province Center for Disease Control and Prevention , Nanjing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xue","family":"Wang","sequence":"additional","affiliation":[{"name":"CanSino Biologics , Tianjin , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shipo","family":"Wu","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biotechnology, Academy of Military Medical Sciences , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"CanSino Biologics , Tianjin , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinbo","family":"Gou","sequence":"additional","affiliation":[{"name":"CanSino Biologics , Tianjin , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haitao","family":"Huang","sequence":"additional","affiliation":[{"name":"CanSino Biologics , Tianjin , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongbin","family":"Wu","sequence":"additional","affiliation":[{"name":"Taizhou Center for Vaccine Clinical Research , Taizhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuewen","family":"Wang","sequence":"additional","affiliation":[{"name":"Shanghai Canming Medical Technology , Shanghai , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Chen","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biotechnology, Academy of Military Medical Sciences , Beijing , China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,9,22]]},"reference":[{"key":"2022082503011841700_CIT0001","volume-title":"WHO coronavirus (COVID-19) dashboard.","author":"World Health Organization."},{"key":"2022082503011841700_CIT0002","volume-title":"Our World in Data. 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