Thiem Vu Dinh, Quang Nguyen Dang, Tuan Nguyen Hai, Cheon Kyeongmi, Gallagher Nancy, Luxembourg Alain, Group Thomas, Badshah Cyrus
National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Merck & Co., Inc., Kenilworth, NJ, USA.
Hum Vaccin Immunother. 2021 Jul 3;17(7):1980-1985. doi: 10.1080/21645515.2020.1865739. Epub 2021 Apr 12.
This open-label, single-center, Phase 3 study (NCT03546842) assessed the immunogenicity and safety of the nine-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine in Vietnamese males and females, with the aim to support 9vHPV vaccine licensure in Vietnam. Participants aged 9-26 years received three 9vHPV vaccine doses (Day 1, Month 2, Month 6). Serum samples were obtained on Day 1 (pre-vaccination) and at Month 7 (one month post-Dose 3) for the measurement of anti-HPV antibodies. Geometric mean titers (GMTs) and seroconversion percentages were obtained using the HPV-9 competitive Luminex immunoassay. Injection-site adverse events (AEs), systemic AEs, serious AEs (SAEs), and study discontinuations due to AEs were recorded. Of 201 participants enrolled, 200 (99.5%) received ≥1 vaccine dose. All participants who received the three-dose regimen (198/200, 98.5%) seroconverted for all 9vHPV vaccine types by Month 7. Robust anti-HPV GMT responses were also observed. Half of participants (50.5%) reported ≥1 AE; the majority were injection-site-related (45.0%) and mild (43.0%). There were no deaths, vaccine-related SAEs, or discontinuations due to AEs. Administration of three 9vHPV vaccine doses was highly immunogenic and resulted in acceptable seropositivity percentages for all vaccine HPV types. The 9vHPV vaccine was generally well tolerated among this study population.: Vietnam: clinicaltrials.gov Identifier NCT03546842.
这项开放标签、单中心的3期研究（NCT03546842）评估了九价人乳头瘤病毒（9vHPV；HPV6/11/16/18/31/33/45/52/58）疫苗在越南男性和女性中的免疫原性和安全性，旨在支持该疫苗在越南获得许可。9至26岁的参与者接种了三剂9vHPV疫苗（第1天、第2个月、第6个月）。在第1天（接种前）和第7个月（第3剂接种后1个月）采集血清样本，用于检测抗HPV抗体。使用HPV-9竞争性Luminex免疫测定法获得几何平均滴度（GMT）和血清转化率。记录注射部位不良事件（AE）、全身AE、严重AE（SAE）以及因AE导致的研究中断情况。在纳入的201名参与者中，200名（99.5%）接受了≥1剂疫苗。所有接受三剂接种方案的参与者（198/200，98.5%）在第7个月时对所有9vHPV疫苗类型均发生了血清转化。还观察到了强烈的抗HPV GMT反应。一半的参与者（50.5%）报告了≥1次AE；大多数与注射部位有关（45.0%）且为轻度（43.0%）。没有死亡病例、与疫苗相关的SAE或因AE导致的研究中断。接种三剂9vHPV疫苗具有高度免疫原性，并且所有疫苗HPV类型的血清阳性率均可接受。在该研究人群中，9vHPV疫苗总体耐受性良好。越南：clinicaltrials.gov标识符NCT03546842。
