Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Department of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.
Hum Vaccin Immunother. 2022 Nov 30;18(5):2052700. doi: 10.1080/21645515.2022.2052700. Epub 2022 Mar 31.
The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the base study were selected and invited for this long-term follow-up (LTFU) study to assess the long-term effectiveness of the 4vHPV vaccine in preventing HPV-related diseases. A total of 368 participants were included in this LTFU study with a median follow-up of 94 months. Among 27 participants (Vaccine vs. Placebo: 8 vs. 19) who underwent colposcopy and biopsy due to cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) was observed in the vaccine group while two HPV-16-related cases (CIN1/VaIN) were observed in the placebo group. There were another two HPV-related cases (non-vaccine HPV types) found in the placebo group. Consistent with the findings from global studies that suggested long-term efficacy of 4vHPV vaccine, our study showed continued protective effect of 4vHPV vaccine against HPV-related precancerous diseases through a median follow-up time of 94 months with the longest follow-up time of 125 months after completing three doses of vaccination among Chinese women 20-45 years of age.
四价人乳头瘤病毒（HPV）疫苗已在全球范围内证实对预防 HPV 相关疾病具有有效性，可预防女性和男性的 HPV 相关疾病。在中国进行的一项 III 期、随机、双盲疗效研究（基础研究，NCT00834106）显示，该疫苗对 HPV 16/18 相关的宫颈上皮内瘤变具有 100%的效力，对 HPV 持续感染的效力可维持 78 个月。本长期随访（LTFU）研究入选了基础研究中接种过三剂四价 HPV 疫苗或安慰剂且年龄在 20-45 岁的参与者，以评估四价 HPV 疫苗在预防 HPV 相关疾病方面的长期有效性。本 LTFU 研究共纳入 368 名参与者，中位随访时间为 94 个月。在因宫颈细胞学异常或 HPV 感染而行阴道镜和活检的 27 名参与者中（疫苗组：8 例；安慰剂组：19 例），疫苗组未观察到 HPV-16/18 相关的宫颈上皮内瘤变（CIN）、外阴上皮内瘤变（VIN）或阴道上皮内瘤变（VaIN）病例，而安慰剂组观察到 2 例 HPV-16 相关的病例（CIN1/VaIN）。安慰剂组还发现了另外 2 例 HPV 相关病例（非疫苗 HPV 型）。与全球研究的结果一致，即四价 HPV 疫苗具有长期有效性，本研究显示，在中国 20-45 岁女性中，完成三剂疫苗接种后中位随访时间为 94 个月，最长随访时间为 125 个月，四价 HPV 疫苗对 HPV 相关癌前病变具有持续的保护作用。
