A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
研究概览
简要总结
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
详细描述
The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant is in good physical health
- •Participant has had a lifetime history of 0 to 4 sexual partners
- •Females between 18-to-24 years
排除标准
- •Participant has a history of abnormal Pap test
- •Participant has a history of positive test for HPV
- •Participant has a history of recent or ongoing alcohol or drug abuse
- •Participant is immunocompromised or has an autoimmune condition
- •Participant has received immunosuppressive therapy within a year of screening
- •Participant has previously received an HPV vaccine
- •Participant is pregnant
- •Participant has a history of external genital/vaginal warts
- •Participant is currently enrolled in a clinical trial
- •Participant has a history of a severe allergic reaction that required medical attention
结局指标
主要结局
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
时间窗: 4 weeks postdose 3 (Phase A)
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
时间窗: 4 weeks postdose 3 (Phase B)
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
时间窗: 4 weeks postdose 3 (Phase A)
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
时间窗: 4 weeks postdose 3 (Phase B)
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
次要结局
未报告次要终点