JNCI：尽早接种四价人乳头状瘤病毒疫苗可提高有效性

尖锐湿疣或生殖器疣的发病能最早评价人类乳头状瘤病毒疫苗的有效性。对于人类乳头状瘤病毒疫苗项目而言，在设计有效性研究时事先设定精确的纳入标准和排除标准的做法并不适合现实生活中疫苗研究的开展，因为其所针对的受试者人群不够广泛。来自瑞典Karolinska医学院的Amy Leval等为了评估四价人类乳头状瘤病毒疫苗的有效性而将整个瑞典人群的个体水平数据纳入了研究之中。他们的研究主要是根据生殖器疣的发病率来评价疫苗的有效性，研究结果发表在JCNI 4月的期刊上。
本研究为开放式研究，纳入的是年龄在10岁至44岁之间女性，这些女性在2006年至2010年期间在瑞典生活，研究者根据上述受试者的数据来评价生殖器疣的发病率和人类乳头状瘤病毒疫苗接种之间的关系。在疫苗有效性评价方面，研究者采用事件-时间分析来估计生殖器疣发病率的比率，并根据受试者的年龄、父母的受教育水平对研究结果进行了调整，同时根据受试者第一次疫苗接种的时间对受试者进行分层。
在2006年至2010年期间，共纳入了124000名女性受试者。研究者发现，如果受试者的父母中至少有一人接受过大学教育，那么她们在30岁前接受疫苗接种的概率——比起父母仅接受过高中教育的受试者而言——要增高15倍，相对风险比为15.45，95%可信区间为14.65-16.30。在年龄超过20岁的受试者中，研究者观察到，没有接种过疫苗的女性生殖器疣的发病率降低，这提示人乳头状瘤病毒疫苗优先应用于生殖器疣高危风险的女性中。在接种过3剂疫苗并且第一次接种时间在20岁以前的女性受试者中，其疫苗的有效性为76%（95%可信区间为73%-79%）。研究者发现，在14岁之前接种疫苗的女性其疫苗的有效性最高——93%（95%可信区间为73%-98%）。
本研究结果显示，为了将四价人类乳头状瘤病毒疫苗的有效性最大化，我们迫切需要尽早进行疫苗接种。
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Quadrivalent human papillomavirus vaccine effectiveness: a Swedish national cohort study.
Background
Incidence of condyloma, or genital warts (GW), is the earliest possible disease outcome to measure when assessing the effectiveness of human papillomavirus (HPV) vaccination strategies. Efficacy trials that follow prespecified inclusion and exclusion criteria may not be fully generalizable to real-life HPV vaccination programs, which target a broader segment of the population. We assessed GW incidence after on-demand vaccination with quadrivalent HPV vaccine using individual-level data from the entire Swedish population.
Methods
An open cohort of girls and women aged 10 to 44 years living in Sweden between 2006 and 2010 (N > 2.2 million) was linked to multiple population registers to identify incident GW in relation to HPV vaccination. For vaccine effectiveness, incidence rate ratios of GW were estimated using time-to-event analyses with adjustment for attained age and parental education level, stratifying on age at first vaccination.
Results
A total of 124 000 girls and women were vaccinated between 2006 and 2010. Girls and women with at least one university-educated parent were 15 times more likely to be vaccinated before age 20 years than girls and women whose parents did not complete high school (relative risk ratio = 15.45, 95% confidence interval [CI] = 14.65 to 16.30). Among those aged older than 20 years, GW rates declined among the unvaccinated, suggesting that HPV vaccines were preferentially used by women at high risk of GW. Vaccination effectiveness was 76% (95% CI = 73% to 79%) among those who received three doses of the vaccine with their first dose before age 20 years. Vaccine effectiveness was highest in girls vaccinated before age 14 years (effectiveness = 93%, 95% CI = 73% to 98%).
Conclusions
Young age at first vaccination is imperative for maximizing quadrivalent HPV vaccine effectiveness.
Prophylactic human papillomavirus (HPV) vaccination programs have been launched around the world with the aim of preventing cervical cancer and other HPV-related cancers. Vaccinated cohorts in Sweden are still too young to assess effectiveness against precancerous lesions or invasive HPV-related cancers. Condyloma acuminata, also referred to as genital warts (GWs), has a shorter incubation time after incident HPV infection and as such is ideal to measure in early evaluations of HPV vaccine effectiveness.