Wei Mingwei, Han Weiwei, Zhang Jing, Liu Yongjiang, Yu Hongyang, Li Jingxin, Wang Wenjuan
School of Public Health, National Vaccine Innovation Platform, Nanjing Medical University, Nanjing 211166, China.
Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing 210009, China.
Vaccines (Basel). 2025 May 13;13(5):511. doi: 10.3390/vaccines13050511.
Prophylactic human papillomavirus (HPV) vaccination substantially alleviates cervical cancer burden. This study aimed to evaluate the safety, tolerability, and immunogenicity of an -expressed recombinant nonavalent HPV vaccine.
A dose-escalating phase 1 clinical trial was conducted in Sheyang County, Jiangsu Province, China. Each participant received either the test vaccine or the control vaccine (Gardasil 9) following a 0/2/6-month schedule. Adverse reactions (ARs) within 7 days after vaccination, adverse events (AEs) within 30 days, and serious adverse events (SAEs) throughout the study were recorded. Blood parameters were measured before and 3 days after each dose. Serum immunoglobulin G (IgG) and neutralizing antibodies (nAbs) against nine HPV types were analyzed at months 0, 3, and 7.
A total of 160 women aged 18-45 years were enrolled, and 155 participants completed the full vaccination regimen. Within 7 days following vaccination, the incidence of ARs ranged from 56.67% to 90.00%, with the low-dose group showing a significantly higher rate than the control group ( = 0.004). Most AEs were mild or moderate, and no vaccine-related SAEs occurred. No significant differences were observed among the four groups regarding the incidence of abnormal laboratory findings. Seroconversion rates for nAbs and IgG against nine HPV types exceeded 97.92% following three doses. High levels of nAbs and IgG were observed at months 3 and 7, with geometric mean titers (GMTs) showing further increases by month 7.
This new recombinant nonavalent HPV vaccine exhibits good tolerability and strong immunogenicity among women aged 18-45 years, supporting further efficacy studies in larger populations.
预防性人乳头瘤病毒（HPV）疫苗接种可大幅减轻宫颈癌负担。本研究旨在评估一种表达的重组九价HPV疫苗的安全性、耐受性和免疫原性。
在中国江苏省射阳县进行了剂量递增的1期临床试验。每位参与者按照0/2/6月的接种程序接受试验疫苗或对照疫苗（佳达修9）。记录接种后7天内的不良反应（ARs）、30天内的不良事件（AEs）以及整个研究期间的严重不良事件（SAEs）。在每次接种前和接种后3天测量血液参数。在第0、3和7个月分析针对九种HPV类型的血清免疫球蛋白G（IgG）和中和抗体（nAbs）。
共招募了160名年龄在18至45岁之间的女性，155名参与者完成了完整的疫苗接种方案。接种后7天内，ARs的发生率在56.67%至90.00%之间，低剂量组的发生率显著高于对照组（P = 0.004）。大多数AE为轻度或中度，未发生与疫苗相关的SAEs。四组之间在实验室检查异常发生率方面未观察到显著差异。三剂接种后，针对九种HPV类型的nAbs和IgG的血清转化率超过97.92%。在第3和7个月观察到高水平的nAbs和IgG，几何平均滴度（GMTs）在第7个月进一步升高。
这种新型重组九价HPV疫苗在18至45岁女性中表现出良好的耐受性和强大的免疫原性，支持在更大人群中进行进一步的疗效研究。
