Age distribution of human papillomavirus infection and neutralizing antibodies in healthy Chinese women aged 18-45 years enrolled in a clinical trial
Age distribution of human papillomavirus infection and neutralizing antibodies in healthy Chinese women aged 18-45 years enrolled in a clinical trial
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参加临床试验的18-45岁中国健康女性人乳头瘤病毒感染和中和抗体的年龄分布
DOI：
10.1016/j.cmi.2019.12.010
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发表时间：
2020-08-01
影响因子：
14.2
通讯作者：
Xia，N-S
中科院分区：
文献类型：
--
作者：
Wei，L-H;Su，Y-Y;Xia，N-S
人乳头瘤病毒（HPV）疫苗的临床试验数据显示，（类型特异性抗体和DNA均为阴性）的疫苗类型将从接种中获益;因此，了解不同年龄组中未接受过HPV疫苗接种的妇女的比例对于制定HPV疫苗接种策略非常重要。在中国五省共招募了7372名18-45岁的健康女性。在进入时收集每个妇女的宫颈标本和血清样本。宫颈标本先用HPV DNA酶免疫法检测，阳性者再用反向杂交线探针法和HPV-16、HPV-18特异性聚合酶链反应检测。用假病毒中和试验检测HPV-16或HPV-18的中和抗体。结果高危型HPV DNA的总检出率为14.8%（1088/7367，95%CI 14.0-15.6），HPV-16和HPV-18中和抗体阳性率为12.6%（925/7367）和4.9%（364/7367）。在年轻女性（18-26岁）和中年女性（27-45岁）中，分别有83.8%（3116/3719）和81.4%（2968/3648）对HPV-16和HPV-18均为初治（中和抗体和DNA均为阴性）。此外，本发明还提供了一种方法，百分之九十八点五（3664/3719）和98.0%（3575/3648）的年轻或中年妇女对至少一种HPV类型是初治的HPV-16或HPV-18的感染。讨论本研究显示，大多数18-26岁和27-45岁的中国女性对HPV-16和HPV-18均未感染。18，因此将从二价HPV疫苗接种中获得充分益处。
ObjectivesData from clinical trials of human papillomavirus (HPV) vaccines showed that women naïve (negative for both type-specific antibodies and DNA) to vaccine types would derive benefit from vaccination; therefore, an understanding of the proportion of naïve women in different age groups is important for developing HPV vaccination strategies.MethodsFrom November 2012 to April 2013, a total of 7372 healthy women aged 18–45 years were recruited in five provinces in China. Cervical specimens and serum samples were collected for each woman at entry. Cervical specimens were first tested by the HPV DNA enzyme immunoassay method; if positive, the specimens were then tested by reverse hybridization line probe assay and HPV-16 and HPV-18 specific polymerase chain reactions. Neutralizing antibodies against HPV-16 or HPV-18 were tested with a pseudovirion-based neutralization assay.ResultsThe overall prevalence of high-risk HPV DNA was 14.8% (1088/7367, 95% CI 14.0–15.6), and the seroprevalence of neutralizing antibodies against HPV-16 and HPV-18 was 12.6% (925/7367) and 4.9% (364/7367), respectively. In younger women (18–26 years) and middle-aged women (27–45 years), 83.8% (3116/3719) and 81.4% (2968/3648) were naïve to both HPV-16 and HPV-18 (both neutralizing antibodies and DNA were negative), respectively. In addition, 98.5% (3664/3719) and 98.0% (3575/3648) of the younger or middle-aged women were naïve to at least one HPV type (HPV-16 or HPV-18).DiscussionThis study revealed that the majority of Chinese women aged 18–26 years and 27–45 years were naïve to both HPV-16 and HPV-18 and would thus derive full benefit from bivalent HPV vaccination.