This is a randomized, double-blind,

This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant.
Secondary objectives of the study include:
Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo.
Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
Time to first clinical and/or virologic recurrence,
Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine,
Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods.
Evaluation of cellular and humoral responses to GEN-003 antigens.
Additional objectives include:
Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above.
Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study.
Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.

Condition Intervention Phase
Genital Herpes Simplex Type 2
Biological: Matrix-M2 Adjuvant
Biological: GEN-003 Vaccine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex
U.S. FDA Resources

Further study details as provided by Genocea Biosciences, Inc.:

Primary Outcome Measures:
Change in proportion of days with detectable viral shedding [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate [ Time Frame: 53 weeks ] [ Designated as safety issue: No ]
Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 315
Study Start Date: July 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GEN-003 30μg / Matrix-M 25μg
GEN-003/M2: GEN-003 (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
Biological: Matrix-M2 Adjuvant
Matrix-M2 adjuvant (25, 50 or 75 μg), administered in combination with GEN-003 vaccine as a 0.5 mL intramuscular (IM) injection.
Matrix-M2 is made up of immune stimulating complexes derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. Quillaja saponins are surface-active substances derived from the tree Quillaja saponaria Molina.
Other Names:
Matrix M2
Matrix M
Matrix-M
Biological: GEN-003 Vaccine
GEN-003 Vaccine (30 or 60μg of each antigen) in combination with Matrix-M2 Adjuvant, administered as a 0.5mL intramuscular injection
GEN-003 is a HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens:
GB208: a T cell antigen and internal fragment of the immediate early (IE) protein ICP4.
GB217: a B cell antigen (also known as glycoprotein D, or gD)
Othe

結果 (中文) 1:

This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant.Secondary objectives of the study include:Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo.Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:Time to first clinical and/or virologic recurrence,Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine,Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods.Evaluation of cellular and humoral responses to GEN-003 antigens.Additional objectives include:Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above.Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study.Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.Condition Intervention Phase生殖器疱疹单纯形类型 2生物: 矩阵-M2 佐剂生物: 创-003 疫苗药物: 安慰剂第二阶段研究类型: 介入研究设计: 分配: 随机终结点分类: 安全/效果研究干预模式: 析因转让掩蔽: 双盲 (主体、 照顾者、 研究者、 成果评)主要用途: 治疗官方的标题: 随机、 双盲、 阶乘研究来比较不同的组合，GEN-003 和矩阵-M2 生殖器 HSV-2 感染患者的疗效及安全性缅甸新光报提供的资源链接:相关专题: 生殖器疱疹单纯疱疹美国 FDA 资源进一步研究 Genocea 生物科学公司所提供的细节:主要观察指标:天与检出病毒脱落比例变化 [时限: 6 周] [指定为安全问题: 无]二次结果的措施:免疫原性测定体液 (抗体) 和疫苗抗原的 T 细胞反应 [时间框架: 33 周] [指定为安全问题: 无]对单纯疱疹病毒 2 临床疾病的影响基于时间复发和病变率 [时间框架: 53 个星期] [指定为安全问题: 无]作为一项措施的安全性和耐受性的不良事件患者数目 [时间框架: 57 周] [指定为安全问题: 是的]估计注册: 315研究开始日期: 7 月 2014 2014年估计的研究完工日期: 5 月 2016 2016年估计主要完成日期: 2016 2016年 3 月 (主要结局指标最终数据收集日期)武器分配的干预措施实验: 创-003 30 μ g / 矩阵 M 25μgGEN-003/M2: 创-003 (30 μ g 的每个抗原) 与矩阵 M2 佐剂 (25 μ g)，作为 0.5 毫升注射 (IM) 管理。生物: 矩阵-M2 佐剂矩阵-M2 佐剂 (25、 50 或 75 μ g)，管理创-003 疫苗作为 0.5 毫升注射 (IM) 的结合。矩阵-M2 组成的免疫刺激复合物来自分馏 Quillaja 皂苷、 磷脂酰胆碱和胆固醇。Quillaja 皂苷是表面活性物质来自树 Quillaja 皂质 · 莫利纳。其他名称:矩阵 M2矩阵 M矩阵 M生物: 创-003 疫苗GEN-003 疫苗 (30 或每种抗原 60μg) 结合矩阵-M2 佐剂，0.5 毫升肌内注射作为管理GEN-003 是组成的 2 重组 T 细胞抗原的 HSV-2 蛋白亚单位疫苗:GB208: T 细胞抗原和内部立即早期 (IE) 蛋白 ICP4 的片段。GB217: B 细胞抗原 (也称为糖蛋白 D 或 gD)其他合金钢

結果 (中文) 3:

这是一项随机，双盲，析因研究6种不同的组合之间的病毒脱落GEN-003还原比较，治疗HSV-2疫苗和佐剂
matrix-m2。该研究的次要目标包括：
的安全性与安慰剂相比，组合matrix-m2 GEN-003
耐受性的评价。比较的影响，临床上单纯疱疹病毒2型（HSV-2）抗原和佐剂的GEN-003 matrix-m2测量6个不同的疾病：
首次临床和/或病毒学复发，
谁在疫苗最后一次给药后6个月和12个月无复发者的比例，
病变率（生殖器病变，目前天%）的疫苗接种后抽汲期间。
到GEN-003抗原的细胞和体液免疫反应的评价。
额外的目标包括：
免疫反应和病毒脱落或临床疾病的影响变化的相关性评估
如上定义。测定复发率在不受抑制的抗病毒药物一个子课题的研究。
合格的受试者将进入一个基线期收集肛拭子连续28天之前随机。每一个主题将在21天的时间间隔接收到3次剂量。受试者将遵循安全性和免疫应答12个月最后一次剂量以下。

条件干预相
生殖器单纯疱疹病毒2型
生物：matrix-m2辅助
生物：GEN-003疫苗
药物：安慰剂
2期

研究类型：介入
研究设计：配置：随机
端点分类：安全/疗效研究
干预模式
因子赋值掩蔽：双盲（主体，照顾者，研究者，结果评）
主要目的：治疗
官方头衔：一项随机，双盲，阶乘比较疗效和安全性的不同组合，matrix-m2 GEN-003生殖器HSV-2感染者

资源环节提供的NLM：

MedlinePlus相关的主题：生殖器疱疹的单纯疱疹
美国FDA资源

进一步研究细节由Genocea生物科学公司：
，
主要成果的措施：
在检测病毒脱落[时限天比例的变化：6周] [指定为安全问题：没有]

次要结果：
测定体液免疫原性（抗体）和T细胞反应疫苗抗原[时限：33周] [指定为安全问题：没有]
影响基于临床HSV-2疾病复发时间和病变率[时限：53周] [指定为安全问题：没有]
数量的患者的不良事件作为衡量安全性和耐受性[时限：57周] [指定为安全问题：是]

估计报名：315
研究开始日期：七月2014
估计研究的完成日期：2016
初步估计完工日期：3月2016（最后的主要结果测量数据收集日期）
武器分配干预实验：
GEN-003 30μ克/ M 25μG
GEN-003 /平方米：GEN-003（30μG各抗原与佐剂（25）matrix-m2μG），作为一个0.5毫升肌肉注射（IM）注射。
生物：matrix-m2辅助
matrix-m2佐剂（25，50或75μG），在与GEN-003疫苗0.5毫升肌肉注射（IM）联合给药。
matrix-m2由免疫刺激来自分离的皂树皂苷，磷脂复合物，和胆固醇。皂树皂甙有表面活性的物质来自树Quillaja皂莫丽娜。
其他名称：
矩阵M2
矩阵M M

生物：疫苗
GEN-003GEN-003疫苗（30或60μG各抗原）与matrix-m2佐剂组合，为0.5ml肌内注射
GEN-003是HSV-2病毒蛋白亚单位疫苗由2个重组T细胞抗原进行管理：
gb208：T细胞抗原和即刻早期内部碎片（IE）蛋白：一
gb217 ICP4。B细胞抗原（也被称为糖蛋白D，或其他
GD）