Center for Family Health Research, Kigali, Rwanda.
Rwanda Zambia Health Research Group, Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, Georgia, USA.
J Infect Dis. 2023 Jan 11;227(2):268-277. doi: 10.1093/infdis/jiac283.
From 2019 to 2021, Rwandan residents of the border with the Democratic Republic of the Congo were offered the Ad26.ZEBOV (adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein) and MVA-BN-Filo (modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and nucleoprotein from Tai Forest viruses) Ebola vaccine regimen.
Nonpregnant persons aged ≥2 years were eligible. Unsolicited adverse events (UAEs) were reported through phone calls or visits, and serious adverse events (SAEs) were recorded per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.
Following Ad26.ZEBOV, UAEs were reported by 0.68% of 216 113 vaccinees and were more common in younger children (aged 2-8 years, 1.2%) compared with older children (aged 9-17 years, 0.4%) and adults (aged ≥18 years, 0.7%). Fever and headache were the most reported symptoms. All 17 SAEs related to vaccine were in children aged 2-8 years (10 postvaccination febrile convulsions ± gastroenteritis and 7 fever and/or gastroenteritis). The incidence of febrile seizures was 8 of 26 062 (0.031%) prior to initiation of routine acetaminophen in December 2020 and 2 of 15 897 (0.013%) thereafter. Nonobstetric SAEs were similar in males and females. All 20 deaths were unrelated to vaccination. Young girls and adult women with UAEs were less likely to receive the second dose than those without UAEs. Seven unrelated SAEs occurred in 203 267 MVA-BN-Filo recipients.
Postvaccination febrile convulsions in young children were rare but not previously described after Ad26.ZEBOV and were reduced with routine acetaminophen. The regimen was otherwise safe and well-tolerated.
2019 年至 2021 年，与刚果民主共和国接壤的卢旺达居民接种了 Ad26.ZEBOV（编码埃博拉病毒糖蛋白的腺病毒 26 型载体疫苗）和 MVA-BN-Filo（改良痘苗病毒安卡拉载体疫苗，编码来自埃博拉、苏丹、马尔堡和泰森林病毒的糖蛋白和核蛋白）埃博拉疫苗方案。
年龄≥2 岁的非孕妇有资格接种。通过电话或访问报告未征求意见的不良事件（UAEs），并根据国际人用药品注册技术协调会的指南记录严重不良事件（SAEs）。
在接种 Ad26.ZEBOV 后，216113 名疫苗接种者中有 0.68%报告了 UAEs，年龄较小的儿童（2-8 岁，1.2%）比年龄较大的儿童（9-17 岁，0.4%）和成年人（年龄≥18 岁，0.7%）更常见。发热和头痛是最常见的症状。所有与疫苗相关的 17 例 SAE 均发生在 2-8 岁的儿童中（10 例接种后热性惊厥伴肠胃炎和 7 例发热和/或肠胃炎）。在 2020 年 12 月开始常规使用对乙酰氨基酚之前，26062 例中有 8 例（0.031%）发生热性惊厥，此后 15897 例中有 2 例（0.013%）。男性和女性的非产科 SAE 相似。所有 20 例死亡均与疫苗接种无关。有 UAEs 的年轻女孩和成年女性接种第二剂的可能性低于没有 UAEs 的女性。在 203267 名 MVA-BN-Filo 接种者中，发生了 7 例无关的 SAE。
年幼儿童接种疫苗后热性惊厥罕见，但此前未在 Ad26.ZEBOV 后描述，常规使用对乙酰氨基酚可减少热性惊厥。该方案在其他方面是安全且耐受良好的。
