Bio-Manguinhos, Fiocruz; Rio de Janeiro, Brazil.
Hum Vaccin Immunother. 2013 Apr;9(4):879-88. doi: 10.4161/hv.22982. Epub 2013 Jan 30.
To verify if the Bio-Manguinhos 17DD yellow fever vaccine (17DD-YFV) used in lower doses is as immunogenic and safe as the current formulation.
Doses from 27,476 IU to 587 IU induced similar seroconversion rates and neutralizing antibodies geometric mean titers (GMTs). Immunity of those who seroconverted to YF was maintained for 10 mo. Reactogenicity was low for all groups.
Young and healthy adult males (n = 900) were recruited and randomized into 6 groups, to receive de-escalating doses of 17DD-YFV, from 27,476 IU to 31 IU. Blood samples were collected before vaccination (for neutralization tests to yellow fever, serology for dengue and clinical chemistry), 3 to 7 d after vaccination (for viremia and clinical chemistry) and 30 d after vaccination (for new yellow fever serology and clinical chemistry). Adverse events diaries were filled out by volunteers during 10 d after vaccination. Volunteers were retested for yellow fever and dengue antibodies 10 mo later. Seropositivity for dengue was found in 87.6% of volunteers before vaccination, but this had no significant influence on conclusions.
In young healthy adults Bio-Manguinhos/Fiocruz yellow fever vaccine can be used in much lower doses than usual. INTERNATIONAL REGISTER: ISRCTN 38082350.
验证比卡乔（Bio-Manguinhos）17DD 黄热病疫苗（17DD-YFV）低剂量使用是否与现行配方一样具有免疫原性和安全性。
27476IU 至 587IU 剂量均能诱导相似的血清转化率和中和抗体几何平均滴度（GMT）。对 YF 血清转化者的免疫力可维持 10 个月。所有组的反应原性均较低。
招募了年轻健康的成年男性（n=900），并将其随机分为 6 组，分别接受从 27476IU 至 31IU 逐渐降低剂量的 17DD-YFV。在接种前（用于黄热病的中和试验、登革热血清学和临床化学）、接种后 3 至 7 天（用于病毒血症和临床化学）和接种后 30 天（用于新的黄热病血清学和临床化学）采集血样。志愿者在接种后 10 天内填写不良事件日记。接种后 10 个月，志愿者再次接受黄热病和登革热抗体检测。接种前，87.6%的志愿者登革热血清阳性，但这对结论没有显著影响。
在年轻健康的成年人中，比卡乔/Fiocruz 黄热病疫苗可使用比常规剂量低得多的剂量。国际注册号：ISRCTN38082350。
