Baylor College of Medicine, Medicine - Infectious Diseases, BCM MS 280, One Baylor Plaza, Houston, TX 77030, United States.
Vaccine. 2010 Apr 9;28(17):3025-9. doi: 10.1016/j.vaccine.2009.10.152. Epub 2009 Nov 18.
In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15 or 45microg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3 or 9microg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (<or=20% or <or=38%, respectively) and similar in groups given 3 or 9microg ID or 15microg IM, and were significantly lower than those given 45microg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.
在一项 I 期临床试验中,将 100 名健康的年轻成年人随机分为四组,分别接受两种剂量的间隔 28 天的亚单位灭活疫苗,其中包含 15 或 45μg 的流感 A/H5N1 血凝素(HA),通过肌内(IM)途径给药,或通过皮内(ID)途径给予 3 或 9μg 的 H5 HA。77 名受试者接受了第三剂。所有方案均安全且耐受良好。两剂或三剂后的抗体反应较低(分别为<20%或<38%),并且在给予 3 或 9μg ID 或 15μg IM 的组中相似,并且明显低于给予 45μg IM 的组。通过 ID 途径增强免疫原性需要更高剂量的 H5 HA 和/或佐剂。