在刚果民主共和国成人和儿童中，Ad26.ZEBOV、MVA-BN-Filo埃博拉疫苗方案延长剂量间隔的免疫原性。
Immunogenicity of an Extended Dose Interval for the Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children in the Democratic Republic of the Congo.
作者信息
Choi Edward Man-Lik, Kasonia Kambale, Kavunga-Membo Hugo, Mukadi-Bamuleka Daniel, Soumah Aboubacar, Mossoko Zephyrin, Edwards Tansy, Tetsa-Tata Darius, Makarimi Rockyath, Toure Oumar, Mambula Grace, Brindle Hannah, Camacho Anton, Connor Nicholas E, Mukadi Pierre, McLean Chelsea, Keshinro Babajide, Gaddah Auguste, Robinson Cynthia, Luhn Kerstin, Foster Julie, Roberts Chrissy H, Johnson John Emery, Imbault Nathalie, Bausch Daniel G, Grais Rebecca F, Watson-Jones Deborah, Muyembe-Tamfum Jean Jacques
机构信息
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK.
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo.
出版信息
Vaccines (Basel). 2024 Jul 23;12(8):828. doi: 10.3390/vaccines12080828.
During the 2018-2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to the COVID-19 pandemic led to some participants receiving a late dose 2 outside the planned interval. Blood samples were collected from adults, adolescents, and children prior to their delayed dose 2 vaccination and 21 days after, and tested for IgG binding antibodies against Ebola virus glycoprotein using the Filovirus Animal Nonclinical Group (FANG) ELISA. Results from 133 participants showed a median two-dose interval of 9.3 months. The pre-dose 2 antibody geometric mean concentration (GMC) was 217 ELISA Units (EU)/mL (95% CI 157; 301) in adults, 378 EU/mL (281; 510) in adolescents, and 558 EU/mL (471; 661) in children. At 21 days post-dose 2, the GMC increased to 22,194 EU/mL (16,726; 29,449) in adults, 37,896 EU/mL (29,985; 47,893) in adolescents, and 34,652 EU/mL (27,906; 43,028) in children. Participants receiving a delayed dose 2 had a higher GMC at 21 days post-dose 2 than those who received a standard 56-day regimen in other African trials, but similar to those who received the regimen with an extended interval.
在2018 - 2020年刚果民主共和国埃博拉病毒病疫情期间，Ad26.ZEBOV、MVA - BN - Filo埃博拉疫苗（DRC - EB - 001）的3期试验在戈马启动，参与者接受间隔56天的两剂接种方案。2020年由于新冠疫情导致试验活动暂停，致使一些参与者在计划间隔之外较晚接种了第2剂。在成年、青少年和儿童延迟接种第2剂疫苗前及接种后21天采集血样，使用丝状病毒动物非临床组（FANG）酶联免疫吸附测定法检测针对埃博拉病毒糖蛋白的IgG结合抗体。133名参与者的结果显示两剂接种的中位间隔时间为9.3个月。接种第2剂前，成人抗体几何平均浓度（GMC）为217酶联免疫吸附测定单位（EU）/mL（95%置信区间157；301），青少年为378 EU/mL（281；510），儿童为558 EU/mL（471；661）。接种第2剂后21天，成人GMC升至22,194 EU/mL（16,726；29,449），青少年为37,896 EU/mL（29,985；47,893），儿童为34,652 EU/mL（27,906；43,028）。接种延迟第2剂的参与者在接种第2剂后21天的GMC高于其他非洲试验中接受标准56天接种方案的参与者，但与接受延长间隔接种方案的参与者相似。
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