Schwarz Tino F, Spaczynski Marek, Schneider Achim, Wysocki Jacek, Galaj Andrzej, Schulze Karin, Poncelet Sylviane M, Catteau Gregory, Thomas Florence, Descamps Dominique
Central Laboratory and Vaccination Centre, Stiftung Juliusspital Würzburg, Germany.
Hum Vaccin. 2011 Sep;7(9):958-65. doi: 10.4161/hv.7.9.15999. Epub 2011 Sep 1.
The HPV-16/18 AS04-adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) has been shown to induce a robust immune response in women aged 15-55 years (103514/NCT00196937). This follow-up study is the first report of persistence of immune response and safety profile through 48 months after vaccination in women aged 15-55 years. In this open-label, age-stratified Phase III study in Germany and Poland (105882/NCT00196937), healthy women aged 15-55 years received 3 doses of HPV-16/18 AS04-adjuvanted vaccine at 0, 1, and 6 months. Anti-HPV-16/18 seropositivity rates and geometric mean antibody titers (GMTs) were assessed by enzyme-linked immunosorbent assay (ELISA) in women aged 15-25 (n=168), 26-45 (n=186) and 46-55 years (n=177) from the time of first vaccination through 48 months. At Month 48, all subjects were seropositive for anti-HPV-16 antibodies and 99.4% were seropositive for anti-HPV-18. Antibody kinetics were as previously reported, with peak response at Month 7 followed by a gradual decline tending towards a plateau in all age groups. Anti-HPV-16/18 GMTs were sustained at Month 48 in all age groups, including women aged 46-55 years in whom GMTs were respectively 11-fold and 5-fold higher than natural infection levels. The vaccine exhibited a clinically acceptable safety profile in all age groups. In summary, the HPV-16/18 AS04-adjuvanted vaccine induces high and sustained immune responses in women aged 15-55 years, with antibody levels remaining several-fold higher than natural infection levels for at least 4 years after the first vaccine dose.
人乳头瘤病毒16/18 AS04佐剂疫苗（希瑞适®，葛兰素史克生物制品公司）已被证明可在15至55岁女性中诱导强烈的免疫反应（103514/NCT00196937）。这项随访研究是关于15至55岁女性接种疫苗后48个月免疫反应持久性和安全性的首次报告。在德国和波兰进行的这项开放标签、按年龄分层的III期研究（105882/NCT00196937）中，15至55岁的健康女性在0、1和6个月时接种3剂人乳头瘤病毒16/18 AS04佐剂疫苗。通过酶联免疫吸附测定（ELISA）评估了15至25岁（n = 168）、26至45岁（n = 186）和46至55岁（n = 177）女性从首次接种疫苗到48个月时的抗人乳头瘤病毒16/18血清阳性率和几何平均抗体滴度（GMT）。在第48个月时，所有受试者抗人乳头瘤病毒16抗体均为血清阳性，99.4%的受试者抗人乳头瘤病毒18血清阳性。抗体动力学与先前报告一致，所有年龄组在第7个月时反应达到峰值，随后逐渐下降，趋于平稳。所有年龄组在第48个月时抗人乳头瘤病毒16/18 GMT均得以维持，包括46至55岁的女性，其GMT分别比自然感染水平高11倍和5倍。该疫苗在所有年龄组中均表现出临床可接受的安全性。总之，人乳头瘤病毒16/18 AS04佐剂疫苗可在15至55岁女性中诱导高且持续的免疫反应，首次接种疫苗后至少4年抗体水平仍比自然感染水平高几倍。
