Joura Elmar A, Kjaer Susanne K, Wheeler Cosette M, Sigurdsson Kristján, Iversen Ole-Erik, Hernandez-Avila Mauricio, Perez Gonzalo, Brown Darron R, Koutsky Laura A, Tay Eng Hseon, García Patricia, Ault Kevin A, Garland Suzanne M, Leodolter Sepp, Olsson Sven-Eric, Tang Grace W K, Ferris Daron G, Paavonen Jorma, Lehtinen Matti, Steben Marc, Bosch Xavier, Dillner Joakim, Kurman Robert J, Majewski Slawomir, Muñoz Nubia, Myers Evan R, Villa Luisa L, Taddeo Frank J, Roberts Christine, Tadesse Amha, Bryan Janine, Lupinacci Lisa C, Giacoletti Katherine E D, Lu Shuang, Vuocolo Scott, Hesley Teresa M, Haupt Richard M, Barr Eliav
Department of Gynecology and Obstetrics, Medical University of Vienna, Vienna, Austria.
Vaccine. 2008 Dec 9;26(52):6844-51. doi: 10.1016/j.vaccine.2008.09.073. Epub 2008 Oct 16.
The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.
四价人乳头瘤病毒(HPV)疫苗的效力被认为是由体液免疫介导的。我们评估了四价HPV疫苗诱导的血清抗HPV反应与效力之间的相关性。17622名女性在第1天以及第2个月和第6个月时接种了疫苗。在第1天以及之后长达48个月的时间里,每隔6 - 12个月,受试者接受巴氏涂片检查和生殖器HPV检测。由于病例数较少,未发现保护的免疫相关性。尽管在研究结束时40%的疫苗接种受试者抗HPV 18血清学阴性,但尽管安慰剂组的发病率较高,针对HPV 18相关疾病的效力仍然很高(98.4%;95%可信区间:90.5 - 100.0)。这些结果表明疫苗通过免疫记忆诱导保护,或者抗HPV 18抗体滴度低于可检测水平。