Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong.
Hong Kong Med J. 2010 Jun;16(3):171-9.
To assess the immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in Chinese women aged 18 to 35 years enrolled from Hong Kong.
Double-blind, randomised controlled trial with vaccine and placebo groups.
Single-centre study in Hong Kong.
Three hundred women enrolled (150 per group) between March 2006 and June 2007.
Subjects received three doses of human papillomavirus-16/18 vaccine or placebo (aluminium hydroxide), administered intramuscularly at 0, 1, and 6 months.
Human papillomavirus-16/18 seroconversion rates and geometric mean titres at month 7 (in human papillomavirus-16/18 recipients); reactogenicity and safety (in all subjects).
A total of 294 women completed the study (148 in the vaccine group, 146 in placebo group). All initially seronegative subjects in the vaccine group had seroconverted for human papillomavirus-16/18 antibodies by month 7. Anti-human papillomavirus-16 and anti-human papillomavirus-18 antibody geometric mean titres were 10 422 (95% confidence interval, 8730-12 442) EL.U/mL and 4649 (3975-5437) EL.U/mL, respectively. High compliance (99% in both groups) was observed for the three-vaccination course. The frequencies of local injection site reactions were higher in the vaccine than placebo group; pain being the most common symptom in both groups. Regarding solicited symptoms, fatigue and myalgia were the most frequent in both groups. Five serious adverse events (four in vaccine group, one in placebo group) were reported, but all were considered unrelated to the vaccinations.
The human papillomavirus-16/18 AS04-adjuvanted vaccine was highly immunogenic, safe, and generally well tolerated in Chinese women from Hong Kong.
评估 HPV-16/18 AS04 佐剂宫颈癌疫苗在香港 18-35 岁女性中的免疫原性和安全性。
双盲、随机对照试验，设疫苗组和安慰剂组。
香港单中心研究。
2006 年 3 月至 2007 年 6 月期间共招募 300 名女性（每组 150 名）。
受试者分别于 0、1 和 6 个月接受三剂 HPV-16/18 疫苗或安慰剂（氢氧化铝）肌内注射。
HPV-16/18 血清转化率和第 7 个月的几何平均滴度（在 HPV-16/18 疫苗接种者中）；反应原性和安全性（在所有受试者中）。
共 294 名女性完成了研究（疫苗组 148 名，安慰剂组 146 名）。所有最初 HPV-16/18 血清阴性的疫苗组受试者在第 7 个月时均已转为 HPV-16/18 抗体阳性。抗 HPV-16 和抗 HPV-18 抗体的几何平均滴度分别为 10 422（95%置信区间，8730-12 442）EL.U/mL 和 4649（3975-5437）EL.U/mL。三组疫苗接种的依从性均很高（两组均为 99%）。疫苗组的局部注射部位反应频率高于安慰剂组；疼痛是两组最常见的症状。对于应征症状，两组中最常见的是疲劳和肌痛。报告了 5 例严重不良事件（疫苗组 4 例，安慰剂组 1 例），但均认为与疫苗接种无关。
HPV-16/18 AS04 佐剂疫苗在香港的中国女性中具有高度的免疫原性、安全性和良好的耐受性。
