Department of Medicine, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong.
Hong Kong Med J. 2011 Feb;17(1):39-46.
To present Hong Kong'Äìspecific data from a large Asian population (also involving Thailand, Singapore, and Taiwan) on safety and manufacturing consistency across four AS03(A)-adjuvanted H5N1 vaccine formulations in terms of immune response against the A/Vietnam/1194/2004 strain. Immunogenicity against the heterologous A/Indonesia/05/2005 strain was also assessed. NCT Number: 00449670.
Prospective, observer-blind study.
Out-patient clinic of a tertiary hospital in Hong Kong.
A total of 360 subjects aged 18 to 60 years were randomised into six groups to receive two doses (21 days apart) of the study vaccine.
One of the four adjuvanted formulations (3.75 microgram H5N1 haemagglutinin [HA]+AS03(A)) of the vaccine (H5N1-AS03(A)) or one of the two non-adjuvanted (3.75 microgram H5N1 [HA]) formulations of the vaccine (H5N1-DIL).
Blood samples collected before vaccination and 21 days after each vaccine dose were analysed using haemagglutination-inhibition and neutralisation assays. Solicited, unsolicited, and serious adverse events were recorded.
Manufacturing consistency across all four vaccine formulations was demonstrated. After two doses, the AS03(A)-adjuvanted prepandemic influenza vaccine demonstrated high seroprotection rates against the A/Vietnam/1194/2004 strain (95.8%) and good immunogenicity against the heterologous A/Indonesia/05/2005 strain (45.7%), as compared to the non-adjuvanted vaccine (4.6% and 1.5%, respectively). The seroconversion rates induced by the adjuvanted formulations in terms of viral neutralising antibodies against the two strains were much higher than those induced by the non-adjuvanted formulations. There were no safety concerns for any of the adjuvanted vaccine formulations.
The AS03(A)-adjuvanted H5N1 prepandemic influenza vaccine demonstrated good immunogenicity and an acceptable safety profile in Hong Kong.
呈现来自大型亚洲人群（包括泰国、新加坡和中国台湾）的香港特有数据，评估四种 AS03(A)-佐剂 H5N1 疫苗在针对 A/Vietnam/1194/2004 株的免疫反应方面的安全性和制造一致性。还评估了针对异源 A/Indonesia/05/2005 株的免疫原性。NCT00449670。
前瞻性、观察者盲法研究。
香港一家三级医院的门诊诊所。
共 360 名 18 至 60 岁的受试者被随机分为六组，接受两剂（间隔 21 天）研究疫苗。
疫苗的四种佐剂制剂之一（3.75 微克 H5N1 血凝素[HA]+AS03(A)）（H5N1-AS03(A)）或两种非佐剂制剂之一（3.75 微克 H5N1[HA]）（H5N1-DIL）。
在接种前和每次接种疫苗后 21 天采集血样，使用血凝抑制和中和测定进行分析。记录了预期的、未预期的和严重的不良事件。
证明了所有四种疫苗制剂的制造一致性。在接受两剂疫苗后，AS03(A)佐剂的大流行前流感疫苗对 A/Vietnam/1194/2004 株的血清保护率很高（95.8%），对异源 A/Indonesia/05/2005 株的免疫原性良好（45.7%），而非佐剂疫苗分别为 4.6%和 1.5%。与非佐剂制剂相比，佐剂制剂诱导的针对两种菌株的病毒中和抗体的血清转化率要高得多。任何佐剂疫苗制剂都没有安全性问题。
AS03(A)佐剂的 H5N1 大流行前流感疫苗在香港具有良好的免疫原性和可接受的安全性。
