GlaxoSmithKline Vaccines, Wavre, Belgium.
Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9.
During the 2009-2010 Northern Hemisphere influenza season, both seasonal and pandemic influenza vaccines were expected to be administered to elderly people, which is an important target group for influenza vaccination. Two multicentre randomised clinical studies were conducted in participants aged ≥61 years to assess the immunogenicity and reactogenicity following vaccination with two doses of an AS03-adjuvanted A(H1N1)pmd09 vaccine when either sequentially administered (21 days before first dose [N=73] or 21 days after second dose [N=72]) or co-administered (first dose [N=84] or second dose [N=84]) with a licensed trivalent seasonal influenza vaccine (TIV). Overall, 313 participants from 2 centres in Sweden (ClinicalTrials.gov, NCT00968890) and 6 centres in Germany (NCT00971425) were randomised to one of the four treatment groups. The AS03-adjuvanted A(H1N1)pmd09 vaccine elicited a good immune response against A(H1N1)pmd09-like virus in all treatment groups after the first and second dose, meeting and exceeding the European licensing criteria for pandemic influenza vaccines. After one dose of the AS03-adjuvanted A(H1N1)pmd09 vaccine, haemagglutination inhibition seroconversion rates ranged from 85% (95% confidence interval: 74-93%) to 93% (85-97%), seroprotection rates from 87% (76-94%) to 96% (90-99%) and geometric mean fold rise from 15 (11-19) to 20 (16-25). The haemagglutination inhibition immune responses to the AS03-adjuvanted A(H1N1)pmd09 vaccine seemed lower when TIV was administered 3 weeks before, while immune responses to TIV seemed not affected by either vaccination schedule. Solicited symptoms were more frequently reported following administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine compared to TIV, but these were mainly mild to moderate in intensity and transient in the four treatment groups. These results suggest that sequential or co-administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine and TIV induced a good immune response to both vaccines and had a clinically acceptable safety profile in people aged ≥61 years.
在 2009-2010 年北半球流感季节，预计将为老年人接种季节性和大流行流感疫苗，老年人是流感疫苗接种的重要目标人群。在≥61 岁的参与者中进行了两项多中心随机临床试验，以评估在接种两剂 AS03 佐剂 A（H1N1）pmd09 疫苗时的免疫原性和反应原性，接种方式分别为（首剂前 21 天[73 人]或第二剂后 21 天[72 人]）或同时接种（首剂[84 人]或第二剂[84 人]）已许可的三价季节性流感疫苗（TIV）。来自瑞典 2 个中心（ClinicalTrials.gov，NCT00968890）和德国 6 个中心（NCT00971425）的总共 313 名参与者被随机分配到四个治疗组中的一个。AS03 佐剂 A（H1N1）pmd09 疫苗在所有治疗组中，在接种第一剂和第二剂后，对 A（H1N1）pmd09 样病毒均产生了良好的免疫应答，符合并超过了大流行流感疫苗的欧洲许可标准。接种一剂 AS03 佐剂 A（H1N1）pmd09 疫苗后，血凝抑制血清转化率范围为 85%（95%置信区间：74-93%）至 93%（85-97%），血清保护率为 87%（76-94%）至 96%（90-99%），几何平均倍数升高 15（11-19）至 20（16-25）。当 TIV 在接种前 3 周给药时，AS03 佐剂 A（H1N1）pmd09 疫苗的血凝抑制免疫应答似乎较低，而 TIV 的免疫应答似乎不受任何接种方案的影响。与 TIV 相比，接种 AS03 佐剂 A（H1N1）pmd09 疫苗后更常报告有症状，但在四个治疗组中，这些症状主要为轻度至中度，且为一过性。这些结果表明，AS03 佐剂 A（H1N1）pmd09 疫苗与 TIV 序贯或同时接种可诱导对两种疫苗的良好免疫应答，并在≥61 岁人群中具有可接受的临床安全性。
